RU2779601C2 - Nutrition for infants, providing useful metabolic effects - Google Patents

Abstract

FIELD: food industry.

SUBSTANCE: nutritional compositions for complementary food are described, characterized by a low glycemic load, and/or a low glycemic index, and/or containing an ingredient characterized by a low glycemic index, for use in the treatment, prevention, and/or reduction in the risk of development of a disorder related to a metabolic syndrome, manifesting in later life.

EFFECT: invention allows for the reduction in a glycemic load in order to prevent disorders related to a metabolic syndrome in children.

12 cl, 9 dwg, 2 tbl, 9 ex

Description

The field of technology to which the invention belongs

The present invention relates to a nutritional composition for a weaning period for use in the treatment, prevention and/or reduction of the risk of developing a disorder associated with metabolic syndrome manifesting later in life.

State of the art

Evidence from observational studies suggests that postprandial glycemia is implicated in the development of obesity and chronic metabolic disease such as type 2 diabetes and cardiovascular disease in adults.

It is also known that a high degree/duration of insulin response is associated with insulin resistance and the risk of developing type 2 diabetes in adults.

While extensive data are available on the glycemic index (GI) of various foods and their potential health effects in adults, especially diabetics, much less is known in infants/children, especially healthy ones.

The prenatal and early postnatal periods are now recognized as critical periods for early programming. It is now recognized that suboptimal nutrition during critical periods of development may cause long-term changes in organ structures or function, which may predispose individuals to subsequent chronic diseases.

In particular, there is evidence that prenatal and early postnatal nutrition (lactation) plays a role in determining susceptibility to later life development of one or more disorders associated with metabolic syndrome (see, for example, Srinivasan M. et al, “A high carbohydrate diet in the immediate postnatal life of rats induces adaptations predisposing to adult-onset obesity” Journal of endocrinology (2008), 197, 565-574). In any case, very little is known about the long-term metabolic effects of foods intended for complementary feeding and subsequent feeding in young children (< 3 years of age).

Thus, a nutritional composition to be administered during the weaning period would be advantageous in reducing the risk of developing disorders associated with the metabolic syndrome later in life.

There is a particular need for specific nutritional compositions that can be administered at specific intervention periods in the early life of young children and that may have the ability to reduce the risk, prevent, or reduce the severity of suboptimal health conditions that are commonly associated with metabolic syndromes, such as overweight. , obesity, diabetes, or even cardiovascular disease.

In these infants, who are at increased risk of developing these suboptimal conditions, for example due to genetic inheritance, parental health, early developmental difficulties, there is an even greater need.

There is also a need for nutritional compositions to be administered at specific intervention times in the early life of young children, in which the macronutrients that are present in the composition are optimized in accordance with the latest nutritional guidelines.

Thus, in one embodiment, a nutritional composition to be administered during the weaning period that is nutritionally balanced and reduces the risk of developing later life disorders associated with metabolic syndrome would be advantageous.

Disclosure of invention

The present inventors have surprisingly shown that rats fed a low glycemic index, low glycemic load diet during the weaning period experienced a protective effect against impaired glucose homeostasis and insulin response even when fed an adipogenic diet in the adult rat stage. In contrast, rats fed during the weaning period with a diet with a higher glycemic index and glycemic load in the pup stage were not protected.

Accordingly, a first aspect of the present invention relates to a nutritional complementary food composition having a low glycemic load and/or a low glycemic index for use in the treatment, prevention and/or reduction of the risk of developing a later life metabolic syndrome disorder.

The invention also provides a method for treating, preventing and/or reducing the risk that an infant or young child will develop a metabolic syndrome disorder later in life; in particular, when subjected to an adipogenic diet load, said method comprising the step of administering, at the age of an infant or young child, which falls between 4 months and 5 years of age, a nutritional composition having a low glycemic load and/or a low glycemic index.

In another aspect, the present invention provides a complementary nutritional composition comprising at least one low glycemic index ingredient for use in the treatment, prevention, and/or reduction in the risk of developing a metabolic syndrome disorder later in life.

In another aspect, the present invention provides a complementary nutritional composition comprising at least one carbohydrate ingredient having a low glycemic index for use in the treatment, prevention, and/or reduction in the risk of developing a metabolic syndrome disorder later in life.

Another aspect of the present invention relates to the use of at least one carbohydrate ingredient having a low glycemic index for the preparation of a nutritional complementary food composition for use in the treatment, prevention or reduction of a subject's risk of developing a disorder associated with metabolic syndrome later in life.

In a further aspect, the present invention provides the use of a nutritional complementary feeding composition as described in any one of claims 1-25 for the treatment, prevention and/or reduction of the risk of developing a later life metabolic syndrome disorder.

The invention also provides a method for treating, preventing and/or reducing the risk that an infant or young child will develop a metabolic syndrome disorder later in life; in particular, when subjected to an adipogenic diet load, said method comprising the step of administering, at 4 months to 5 years of age, an infant or young child, a nutritional composition comprising at least one ingredient, such as at least one carbohydrate ingredient having a low glycemic load and/or a low glycemic index.

In a further aspect, the present invention provides a nutritional complementary food kit that includes a nutritional complementary food composition having a low glycemic load and/or a low glycemic index and/or containing a low glycemic index ingredient for use in the treatment, prevention and/or risk reduction development of a disorder associated with metabolic syndrome manifesting later in life.

In another aspect, the present invention provides a nutritional complementary food composition comprising:

- flour from cereals in an amount varying in the range from 20 to 90 wt.%;

- sugar in an amount ranging from 0 to 30 wt.%, for example from 0 to 20 wt.%, for example from 5 to 18 wt.%;

- added sugar with a low glycemic index in an amount ranging from 0 to 30 wt.%, for example from 1 to 20 wt.%, for example from 5 to 15 wt.%;

- the total amount of dietary fiber in an amount varying in the range from 0 to 25 wt.%, for example from 2 to 25 wt.%;

- added fiber in an amount ranging from 0 to 20 wt.%;

- legume in an amount ranging from 0 to 40%, for example from 1 to 40%, for example from 5 to 40 wt.%;

- the fruit of the plant in an amount ranging from 0 to 25 wt.%, for example from 1 to 18 wt.%.

In another aspect, the present invention provides a nutritional complementary food composition comprising:

- flour from cereals in an amount varying in the range from 20 to 90 wt.%, for example from 30 to 55 wt.%;

- sugar in an amount ranging from 0 to 30 wt.%, for example from 0 to 20 wt.%, for example from 5 to 18 wt.%;

- added sugar with a low glycemic index in an amount ranging from 0 to 30 wt.%, for example from 1 to 20 wt.%, for example from 5 to 15 wt.%;

- fats in an amount ranging from 8 to 20 wt.% of the composition, for example in the range from 10 to 17 wt.%, for example from 10 to 15 wt.%;

- the total amount of dietary fiber in an amount varying in the range from 0 to 25 wt.%, for example from 2 to 25 wt.%;

- added fiber in an amount ranging from 0 to 20 wt.%;

- dairy ingredient in an amount ranging from 0 to 30 wt.%, for example from 1 to 25 wt.%, for example from 5 to 25 wt.%;

- legume in an amount ranging from 0 to 40%, for example from 1 to 40 wt.%, for example from 5 to 40 wt.%;

- the fruit of the plant in an amount ranging from 0 to 25 wt.%, for example from 1 to 18 wt.%.

In another aspect, the present invention provides a nutritional complementary food composition comprising:

- flour from cereals in an amount varying in the range from 20 to 90 wt.%, for example from 30 to 55 wt.%;

- sugar in an amount ranging from 0 to 30 wt.%, for example from 0 to 20 wt.%, for example from 5 to 18 wt.%;

- added sugar with a low glycemic index in an amount ranging from 0 to 30 wt.%, for example from 1 to 20 wt.%, for example from 5 to 15 wt.%;

- fat in an amount ranging from 8 to 20 wt.% of the composition, for example in the range from 10 to 17 wt.%, for example from 10 to 15 wt.%;

- the total amount of dietary fiber in an amount varying in the range from 0 to 25 wt.%, for example from 2 to 25 wt.%;

- added fiber in an amount ranging from 0 to 20 wt.%;

- dairy ingredient in an amount ranging from 0 to 30 wt.%, for example from 1 to 25 wt.%, for example from 5 to 25 wt.%;

- legume in an amount ranging from 0 to 40%, for example from 1 to 40 wt.%, for example from 5 to 40 wt.%;

- the fruit of the plant in an amount varying in the range from 0 to 25 wt.%, for example from 1 to 18 wt;

for use in the treatment, prevention and/or reduction of the risk of developing a disorder associated with metabolic syndrome manifesting later in life.

In another aspect, the present invention provides a method for treating, preventing and/or reducing the risk that an infant or young child will develop a metabolic syndrome disorder later in life; in particular, when subjected to an adipogenic diet load, said method comprising the step of administering, at the age of an infant or young children, which falls between 4 months and 5 years of age, a nutritional composition comprising:

- flour from cereals in an amount varying in the range from 20 to 90 wt.%, for example from 30 to 55 wt.%;

- sugar in an amount ranging from 0 to 30 wt.%, for example from 0 to 20 wt.%, for example from 5 to 18 wt.%;

- added sugar with a low glycemic index in an amount ranging from 0 to 30 wt.%, for example from 1 to 20 wt.%, for example from 5 to 15 wt.%;

- fat in an amount ranging from 8 to 20 wt.% of the composition, for example in the range from 10 to 17 wt.%, for example from 10 to 15 wt.%;

- the total amount of dietary fiber in an amount varying in the range from 0 to 25 wt.%, for example from 2 to 25 wt.%;

- added fiber in an amount ranging from 0 to 20 wt.%;

- dairy ingredient in an amount ranging from 0 to 30 wt.%, for example from 1 to 25 wt.%, for example from 5 to 25 wt.%;

- legume in an amount ranging from 0 to 40%, for example from 1 to 40 wt.%, for example from 5 to 40 wt.%;

- the fruit of the plant in an amount ranging from 0 to 25 wt.%, for example from 1 to 18 wt.%.

In a further aspect, the present invention provides a nutritional complementary food kit that comprises a nutritional complementary food composition comprising:

- flour from cereals in an amount varying in the range from 20 to 90 wt.%, for example from 30 to 55 wt.%;

- sugar in an amount ranging from 0 to 30 wt.%, for example from 0 to 20 wt.%, for example from 5 to 18 wt.%;

- added sugar with a low glycemic index in an amount ranging from 0 to 30 wt.%, for example from 1 to 20 wt.%, for example from 5 to 15 wt.%;

- fat in an amount ranging from 8 to 20 wt.% of the composition, for example in the range from 10 to 17 wt.%, for example from 10 to 15 wt.%;

- the total amount of dietary fiber in an amount varying in the range from 0 to 25 wt.%, for example from 2 to 25 wt.%;

- added fiber in an amount ranging from 0 to 20 wt.%;

- dairy ingredient in an amount ranging from 0 to 30 wt.%, for example from 1 to 25 wt.%, for example from 5 to 25 wt.%;

- legume in an amount in the range from 0 to 40%, for example from 1 to 40%, for example from 5 to 40 wt.%;

- the fruit of the plant in an amount ranging from 0 to 25 wt.%, for example from 1 to 18 wt.%.

Brief description of the figures

The figure 1 shows a diagram of the experimental design during the study described in example 1.

Figure 2 shows a chart of body weight observed in different groups from example 1 from day 0 to day 21.

Figure 3 shows diagrams of energy consumption in the three groups of example 1 during the intervention period of complementary feeding (phase I) and the follow-up period (phase II).

Figure 4 shows charts of baseline blood glucose levels after 8 hours fasting for the three groups in the experiment described in Example 1.

Figure 5 shows charts of baseline blood insulin levels after 8 hours of fasting for the three groups in the experiment described in Example 1.

Figure 6 shows the postprandial increase in glucose in response to the foods tested in example 9.

Figure 7 shows the postprandial rise in insulin in response to the products tested in example 9.

8 shows the incremental area under the curve (IAUC) of glucose for Prototypes 1 and 2 of Example 7 relative to the glucose IAUC of the reference product of the same Example.

Figure 9 shows the insulin IAUC of prototypes 1 and 2 of example 9 relative to the insulin IAUC of the standard product of the same example. Detailed description of the invention

Definitions

Before discussing the present invention in more detail, the following terms and conventions will first be defined:

In the context of the present invention, unless otherwise indicated, the percentages mentioned are weight percentages (% wt./wt.).

The term "and/or" used in the context of "X and/or Y" should be interpreted as "X" or "Y" or "X and Y".

Numerical ranges herein are intended to include all numbers and subsets of numbers contained within that range, whether specifically disclosed or not. In addition, these numerical ranges should be considered as confirmation of a claim that refers to any number or subset of numbers within this range. For example, the description "1 to 10" should be considered as confirming the range "1 to 8", "3 to 7", "4 to 9", "3.6 to 4.6", "3, 5 to 9.9", etc.

All references to features or limitations of the present invention in the singular shall include the corresponding feature or limitation in the plural, and vice versa, unless otherwise noted or unless the context in which the reference is made expressly implies otherwise.

All technical and scientific terms used in this document, unless otherwise defined, have the generally accepted meaning understood by the average person skilled in the art.

The term "infant" means a child under the age of 12 months.

The term "young child" means a child over 12 months old and up to the age of 5 years (including a toddler).

The expression "child" essentially means a person under the age of eighteen.

"Premature" or "premature" refers to an infant or young child who was not born at term. Essentially, this term refers to an infant born before the 37th week of pregnancy.

The term "term infant" means an infant born after 37 weeks' gestation.

In the context of the present invention, the term "low birth weight" means a newborn weighing less than 2500 g (5.5 lb), as a result of preterm birth (i.e., before 37 weeks of gestation) and/or due to intrauterine growth retardation.

In the context of the present invention, the term "small for gestational age (SGA)" refers to infants with a birth weight that is below the 10th percentile for infants of the same gestational age.

The expression "postnatal period" is the period beginning immediately after the birth of a child and lasting approximately six weeks.

The term "nutritional composition" means a composition fed to a subject. This nutritional composition is typically intended for enteral, oral, parenteral, or intravenous administration and typically includes one or more nutrients selected from a lipid or fat source, a protein source, and a carbohydrate source. Preferably, the nutritional composition is for oral administration.

The expression "artificial composition" means a mixture obtained by chemical and/or biological means, which may be chemically identical to a mixture of natural origin, present in the milk of mammals. In one embodiment of the present invention, the complementary nutritional composition is a synthetic composition.

The expression "infant formula" means a food product specially intended for consumption by infants during the first four to six months of life and which by itself satisfies the nutritional needs of this category of persons (Article 1.2 of European Commission Directive 91/321/EEC of 14 May 1991 on infant formula and complementary formula).

The expression "formula for infants" means a food product specially intended for consumption by infants over four months of age and which constitutes the main liquid component in the diet of this category of persons, which involves progressively increasing diversity.

In the context of the present invention, the term "1 to 3 year old infant formula (GUM)" refers to a formula that can be given to children from 12 months of age, in some cases after the infant formula has been discontinued. "Milk formula for children from 1 to 3 years" (or GUM) is given after one year and beyond. Essentially, it is a milk-based drink adapted to the specific nutritional needs of young children.

In the present context, the term "infant cereal product" refers to a cereal product that has been formulated specifically for infants to provide the infant with essential nutrients.

The expression "infant food" means a food product specifically intended for consumption by infants during the first years of life.

The term "fortifier" refers to liquid or dry nutritional compositions suitable for mixing with breast milk or infant formula.

By "mother's milk" (also "human breast milk", HBM) is meant the mother's breast milk or colostrum.

The term "weaning period" refers to the process of gradually introducing a mammalian infant into what will be its adult diet and supplementing its mother's milk with solid foods. For humans, the weaning period usually begins at an infant's age of 4 to 6 months and is considered complete when the infant is no longer fed breast milk (or substitute infant formula) at all, usually at 24 months of age. In one embodiment, the feeding period is from 4, eg 6, months to 24, eg 18, months of the infant's age.

The term “weaning nutritional composition” or “weaning nutritional composition” means a nutritional composition, as defined above, which is intended to be administered to an infant or young child at or after the onset of the weaning period. In one embodiment, the complementary nutritional composition is administered during the complementary feeding period. This nutritional composition is typically intended for enteral, oral, parenteral, or intravenous administration and typically includes a lipid or fat source, a protein source, and a carbohydrate source. Optionally, these nutritional compositions also contain vitamins and minerals. Preferably, the nutritional composition is for oral administration. Non-limiting examples of complementary nutritional compositions are infant cereals, formula for complementary foods, GUMS, infant formula. Grain foods for babies can be grouped into two main categories: a complete grain product that needs to be diluted in water as it already contains all the essential nutrients that need to be delivered with the meal; and a standard grain product, which means that it must be diluted with milk, infant formula, formula for feeding children and/or GUM.

The term "reduced risk" means that an event has a lower probability of occurring than an appropriate and commonly used reference (eg, the general population or normal weight infants or young children).

The term "prevention" means that the occurrence of an event or disorder is either completely or partially prevented (ie, the event occurs in a milder form and/or occurs later). The terms "prevention" also includes reducing the severity of an event or disorder (or health condition), or reducing the frequency of occurrence of such events or disorders, or delaying the impact on such events or disorders.

The terms "normal weight/overweight/underweight" refer to internationally recognized body weight charts for infants, toddlers and older children and, in particular, depends on the age of the subject.

The expression "glycemic index" (GI) in the context of the present invention means a number associated with a particular type of food/composition and/or ingredient that indicates the effect of a food on a person's blood glucose level. The value of 100 is the standard, the equivalent amount of pure glucose. GI is the overall rise in human blood sugar following consumption of a food/composition/ingredient. The glycemic index of a food is defined as the incremental area under the 2-hour blood glucose response (AUC) curve after 12 hours of fasting and eating a food with a specified amount of available carbohydrates (typically 50 g). The incremental AUC of the test food is divided by the incremental AUC of the standard (either glucose or white bread, giving two different definitions) and multiplied by 100. The mean GI is calculated from data collected from 10 test subjects. Both the standard and the test food must contain equal amounts of available carbohydrates. The result gives a relative rank for each food item tested. In modern validated methods, glucose is used as a standard food product, attributing to it a glycemic index value of 100 by definition.

The glycemic index of an ingredient or food composition can be measured in accordance with the method described in ISO (International Organization for Standardization) 26642:2010 (English version).

Tables are available in the literature that list many types of foods and their GI values (see, for example: “International table of glycemic index and glycemic load values: 2002”, Foster-Powell et al., The American Journal of Clinical Nutrition, 2002, 76:5-56)

In one embodiment, when reference is made to GI in the context of the present invention, it is understood that the GI for that particular ingredient or food product has been measured in healthy adult subjects.

In the context of the present invention, the term "glycemic load" (GL) of a food is a number that measures how much a serving of a food composition will increase a person's blood glucose levels after it is ingested. The glycemic load reflects how many carbohydrates are in a serving of a food and how much each gram of carbohydrates in a serving of a food raises blood glucose levels. The glycemic load is based on the glycemic index (GI) of the ingredients in a food composition and is calculated by multiplying the grams of available carbohydrates in a food by the GI of available carbohydrates and then dividing by 100.

The glycemic load in a serving of a food with different types and amounts of available carbohydrate (CHO) is calculated as the sum of (GI available CHO A per serving x mass of CHO A in food) + (GI of available CHO B x mass of CHO B per serving in food) + the same for each available CHO in food/100.

A suitable serving size will be apparent to one skilled in the art for each type of food product.

As a guide, the following is an illustrative serving size to use when calculating GL for infants:

Whole grain infant (to be diluted in 150 ml of water) = 50 g

Standard Infant Cereal (must be diluted in 160 ml infant formula) = 25 g

Infant formula = 100 ml

Baby food = 100 g.

In the context of the present invention, the term "glucose response" (GR) refers to the postprandial blood glucose response (change in blood concentration) elicited by the consumption of a single serving of a food and is measured by the consumption of a serving of the food regardless of the amount of carbohydrate available.

The glucose response can be measured as described below:

- The concentration of glucose in blood samples (capillary) is analyzed using a calibrated analyzer of glucose and lactate YSI 2300 Stat Plus.

- The increase in blood glucose concentration at various time points (15-120 minutes after ingestion of test meals) is calculated by subtracting the baseline value (blood glucose level before ingestion of test meals) from each value.

- The total area under the two-hour blood glucose response curve (IAUC) is calculated using the trapezoidal rule.

- Results can be expressed as % reaction relative to one standard product.

In the context of the present invention, the term "insulin index" (II) means a number associated with a particular type of food/composition and/or ingredient that indicates the effect of a food on an individual's blood insulin levels. This index is similar to the glycemic index (GI), but instead of being based on blood glucose levels, II is based on blood insulin levels.

II can be calculated from the 2-hour increase in plasma insulin concentration after ingestion of a test food compared to an isoenergetic food (1000 kJ bread) or after ingestion of a test food with 50 g of available carbohydrate (versus 50 g of glucose).

The insulin index of an ingredient or food composition can be measured according to the method described in "An insulin index of food: the insulin demand generated by 100 kJ portions of common foods", Holt HA S. et al, The American Journal of Clinical Nutrition, 1997; 66; 1264-76

In the context of the present invention, the term "insulin response" (IR) means the 2-hour postprandial insulin response in the blood (change in concentration) caused by the amount of test food or meal consumed, and is measured as a curve of plasma insulin levels after consumption of the test food according to compared with the corresponding standard.

The insulin response can be measured as described below:

- Plasma insulin concentration is measured using a human insulin immunoassay kit.

- The increase in plasma insulin concentration at different time points was calculated as explained above for glucose (for GR);

- % reaction relative to the standard product can be calculated as explained above for glucose.

The expression "a nutritional composition having a low glycemic index" in the context of the present invention means a nutritional composition having a glycemic index equal to or less than 70. For example, the glycemic index of such a nutritional composition may be in one embodiment less than or equal to 65, less than or equal to 60 , less than or equal to 55, less than or equal to 50. The expression should be assumed to be the opposite of "a nutritional composition having a high glycemic index", which means a nutritional composition having a glycemic index greater than 70.

The expression "low glycemic index ingredient" in the context of the present invention means a food ingredient having a glycemic index equal to or less than 70. For example, the glycemic index of such a carbohydrate ingredient can be in one embodiment less than or equal to 65, less than or equal to 60, less than or equal to 55, less than or equal to 50, less than or equal to 45.

In the context of the present invention, the expression "low glycemic load nutritional composition" or "low glycemic load nutritional composition" means a nutritional composition having a glycemic load equal to or less than 20. The expression is to be understood as the opposite of "high glycemic load nutritional composition load" which means a nutritional composition having a glycemic load greater than 20. For example, the glycemic load of such a low glycemic load nutritional composition may be less than or equal to 19, less than or equal to 17, less than or equal to 15 in one embodiment. the glycemic load has a value ranging from 15 to 20, for example 16 to 19.

The expression "carbohydrate ingredient" or "carbohydrate ingredients" in the context of the present invention means a food ingredient consisting of or containing one or more carbohydrates. Non-limiting examples of carbohydrate ingredients are: cereal flour varieties (e.g. whole grain or refined flour from maize, wheat, rice, oats), cereal starches (e.g. maize, wheat, oats, rice), sugars [honey, monosaccharides (e.g. , galactose, fructose, glucose), disaccharides (eg sucrose, lactose, isomaltulose, maltose)], oligosaccharides (fructooligosaccharides, galactooligosaccharides, gluco-oligosaccharides, maltodextrins), polysaccharides (eg resistant starches), fiber types (soluble and insoluble), pulses [e.g., green lentils, red lentils, yellow lentils, kidney beans, green beans, mutton peas, lima beans, black-eyed beans, Turkish beans, peas, pigeon peas, soybeans, corn beans and multiflowered beans, kidney beans, soybeans, peas , lupins, horse beans, golden beans, Turkish peas, Chinese cowpea, lentils (red, yellow, green), Tsaregradsky pod, face White/Green/Black/Red Bean, Multiflora Bean, Lima Bean, Pinto Bean, Cayanus, Mungo Bean, Carioquinha Bean, Bambara Groundnut (Vigna subterranean), Pachyrhusus, Canola Flour, Flaxseed Powder, Chestnut Flour], Plant Fruit, Dairy ingredients (e.g. powdered skimmed or whole milk).

The terms "sugar" or "sugar" in the context of the present invention include available monosaccharides (eg galactose, fructose, glucose), available disaccharides (eg sucrose, lactose, isomaltulose, maltose), or mixtures thereof.

In the context of the present invention, the term "added sugar" means an ingredient consisting mainly or entirely of sugar, which is added to a nutritional complementary food composition and whose sugar content contributes to the total sugar content of the composition.

The total sugar content of a nutritional complementary food composition is provided by the sum of the sugars naturally present in the ingredients used in the formulation (e.g. from cereal flour), the sugars that may be obtained during processing, plus the amount of added sugar. As one of skill in the art will appreciate, total sugars will also include any amount of sugar that may be released by the ingredients used in the formulation during processing due to the specific conditions employed (eg, involving partial hydrolysis of starch). Determination of the total sugar content of a nutritional complementary food composition according to the invention can be carried out in accordance with methods well known to the person skilled in the art.

For example, the following method can be used to quantify total sugars in infant cereal products:

Quantification of mono- and disaccharides in infant cereal samples can be done by weighing 1-3 ± 0.001 grams of the sample into a 100 ml volumetric flask and adding 60 ml of demineralized water. The mono- and disaccharides contained in the samples are extracted by placing the flasks in a 70 °C water bath for 20 minutes with constant stirring. The samples are cooled to room temperature and more demineralized water is added up to the mark on each volumetric flask, stoppered and the closed flasks are shaken vigorously. Samples are then filtered through folded filter paper (No. 597, 150 mm Ø) and through a 0.2 µm HPLC filter before injection (25 mm Ø, 8825-P-2 Infochroma AG). A solution containing monomeric glucose, dimeric lactose, sucrose, maltose, isomaltulose and maltooligosaccharides with a degree of polymerization in the range of 3-7 is prepared as a standard for peak identification and saccharide quantification.

The filtered samples are injected into the chromatograph after degassing the eluents (demineralized water, minimum 18 MΩ.cm; 300 mM NaOH; 500 mM NaOH with 150 mM NaOAc), sparging with helium for 20-30 min and allowing the system to equilibrate. The following chromatographic conditions can be used: CarboPac PA1 column and precolumn (Dionex); injection volume 20 µl; eluent 300 mM NaOH with 0.6 ml/min at a flow rate as a post-column addition; temperature 22 °C.

The expression "milk ingredient" or "milk ingredients" in the context of the present invention means carbohydrate-containing ingredients derived from mammalian milk, such as cow, goat and/or buffalo or mixtures thereof. Non-limiting examples of such ingredients include fresh milk, concentrated milk, milk powder, whole milk, skimmed and/or semi-skimmed milk.

As will be appreciated by one of skill in the art, the dairy ingredients of the present invention can provide additional nutrients in addition to carbohydrates, such as proteins and fats, to the complementary nutritional composition.

In the context of the present invention, the term "added sugar with a low glycemic index" means added sugar, as defined above, which has a low glycemic index. To be clear, the amount of lactose contained in any dairy ingredient used in a recipe will also be counted as low glycemic index added sugar.

The expressions "fiber" or "types of fiber" or "dietary fiber" or "types of dietary fiber" in the context of the present invention means the indigestible part of the food product in the small intestine, which comes from plants and includes two main components: soluble fiber, which dissolves in water , and insoluble fiber. The scope of the above terms includes mixtures of different types of fiber. Soluble fiber is readily fermented in the colon into gases and physiologically active by-products and can be prebiotic and viscous. Insoluble fiber is insoluble in water, is metabolically inert and provides swelling, or it may be prebiotic and metabolically fermented in the colon. Chemically, dietary fiber consists of non-starch polysaccharides such as arabinoxylans, cellulose, and many other plant components such as resistant starch, resistant dextrins, inulin, lignin, chitins, pectins, beta-glucans, and oligosaccharides. Non-limiting examples of dietary fiber types are prebiotic fiber types such as fructooligosaccharides (FOS), inulin, galactooligosaccharides (GOS), plant fiber, plant fiber, cereal fiber, resistant starch such as high amylose cereal starch. Since fiber varieties are indigestible, they do not contain available carbohydrates and, as such, they do not contribute to the GI or GL of the composition of which they are part.

In the context of the present invention, the term "added fiber" or "added dietary fiber" means an ingredient consisting mainly or entirely of fiber that is added to a nutritional complementary food composition and whose fiber content contributes to the total fiber content of the composition. The total fiber content of a nutritional complementary food composition is provided by the sum of the amount of fiber naturally present in the ingredients used in the formulation (eg whole grain cereal flour) plus the amount of added fiber.

In the context of the present invention, the term "legume" or "legumes" means the fruits or seeds of a plant of the Fabaceae family or mixtures thereof. Notable legumes include, but are not limited to, alfalfa, clover, peas, beans, lentils, lupins, prosopis, hornwort, soybeans, peanuts, and tamarind. Cereal seeds of such plants are commonly known as "legumes" and are included within the scope of the term "legumes" in accordance with the present invention.

As will be appreciated by one of skill in the art, the legumes of the present invention can provide complementary nutrients in addition to carbohydrates, such as, for example, vitamins, minerals, plant-derived proteins, and/or fiber varieties, to the complementary nutritional composition.

In the context of the present invention, the term "plant fruit" or "plant fruit" means ingredients derived from plant fruits, such as, for example, fresh plant fruit, plant fruit paste, dried plant fruit, extracts and/or centrifuges from plant fruits. The scope of the terms mentioned above also includes mixtures of such ingredients. Non-limiting examples of the fruit of the plant according to the present invention are apple, apricot, banana, cherry, pear, strawberry, mango, orange, peach.

The expression "low glycemic index carbohydrate ingredient" in the context of the present invention means a carbohydrate ingredient having a glycemic index equal to or less than 70. For example, the glycemic index of such a carbohydrate ingredient can be in one embodiment less than or equal to 65, less than or equal to 60, less or equal to 55, less than or equal to 50, less than or equal to 45.

Non-limiting examples of carbohydrate ingredients are cereal flours (e.g., whole grain or refined flour from maize, wheat, rice, oats), sugars [monosaccharides (e.g., galactose, fructose), disaccharides (e.g., sucrose, lactose, isomaltulose), oligosaccharides ( fructooligosaccharides, galactooligosaccharides, glucooligosaccharides)], polysaccharides (eg, resistant starches), fiber types (soluble and insoluble), legumes [especially legumes, eg, green lentils, red lentils, yellow lentils, kidney beans, asparagus beans, mutton peas, lima beans , black-eyed beans, chick beans, peas, pigeon peas, soybeans, corn beans and multi-flowered beans, common beans, soybeans, peas, lupins, horse beans, golden beans, chickpeas, Chinese cowpea, lentils (red, yellow, green ), Tsaregradsky pod, white / green / black / red beans, multi-flowered beans, lima beans, pin beans then, cayanus, mungo bean, potato protein isolate, Carioquinha bean, bambara peanut (Vigna subterranean), pachyrhusus, canola meal, sunflower protein, hemp, flaxseed powder, chestnut flour], plant fruit (e.g., dried fruit or fruit paste plants), dairy ingredients such as powdered skimmed milk or whole milk.

The glycemic index of low glycemic index sugars in one embodiment of the present invention is less than or equal to 70, less than or equal to 60, less than or equal to 45, less than or equal to 35, less than or equal to 30. In one embodiment, the GI of low glycemic index sugars varies in range from 0 to 55, eg 0 to 40. In one embodiment, the sugar is selected, for example, from the group consisting of: galactose, fructose, sucrose, lactose, and isomaltulose.

The glycemic index of legumes in one embodiment of the present invention is less than or equal to 55, less than or equal to 50, less than or equal to 45, less than or equal to 35, less than or equal to 30. In one embodiment, the GI of legumes ranges from 15 to 40, for example from 20 to 35.

The glycemic index of dairy ingredients in one embodiment of the present invention is less than or equal to 55, less than or equal to 50, less than or equal to 45, less than or equal to 35. In one embodiment, the GI of dairy ingredients ranges from 20 to 40, for example, from 25 to 35 .

The glycemic index of the plant fruit in one embodiment of the present invention is less than or equal to 55, less than or equal to 50, less than or equal to 45, less than or equal to 35, less than or equal to 30. In one embodiment, the GI of the legume ranges from 15 to 40, for example 20 to 35. In one embodiment, the plant fruit is a dried plant fruit selected, for example, from the group consisting of apple, apricot, banana, cherry, pear, strawberry, mango, orange and peach.

The expression "fat" or "source of fats" or "lipid" or "source of lipids" or "fats" in the context of the present invention means an edible solid or liquid fat or mixtures thereof. Non-limiting categories of fats are fats of animal, fish or vegetable origin. Non-limiting examples of fats that can be used in accordance with the present invention are, among others, fish oil, cocoa butter, cocoa butter equivalents (CBE), cocoa butter substitutes (CBS), vegetable oils (for example, rapeseed oil, palm oil, corn butter, soybean oil, coconut oil and/or sunflower oil) and cottonseed oils for the production of margarine.

In the context of the present invention, the term "nutrition pack" means all foods in liquid or solid form that are consumed daily by an infant or young child during the period of complementary feeding. In accordance with the present invention, the complementary nutritional kit comprises a complementary nutritional composition having a low glycemic index and/or containing a low glycemic index ingredient. In one embodiment, the complementary food nutritional composition of the present invention provides at least 10%, such as 20%, or 30%, or 50%, or 70%, or 90% of the total calories in the complementary food nutritional set, in which she enters.

In the context of the present invention, if quantities of certain ingredients (such as, for example, sugars, fats, dietary fiber types, etc.) are indicated that may come from various components included in the recipe, then such quantities will reflect the total content of such ingredient in the composition, regardless of the component from which it is derived.

On the other hand, if the present invention refers to an “added” ingredient (such as, for example, added fiber varieties, added low glycemic sugars, etc.), then only the amount of the ingredient that is mainly or completely contains such an ingredient.

Implementation of the invention

The present invention relates in a first aspect to a nutritional complementary food composition having a low glycemic load for use in the treatment, prevention and/or reduction of the risk of developing a later life metabolic syndrome disorder.

The present invention also relates to a nutritional complementary food composition having a low glycemic index for use in the treatment, prevention and/or reduction of the risk of developing a metabolic syndrome disorder later in life.

The present invention also relates to a nutritional complementary food composition having a low glycemic load and a low glycemic index for use in the treatment, prevention and/or reduction of the risk of developing a metabolic syndrome disorder later in life.

In one embodiment of the present invention, the complementary nutritional composition is characterized by the induction of a low glucose response in the subject receiving it.

In one embodiment of the present invention, the nutritional complementary food composition is characterized by the induction of a low insulin response in the subject receiving it.

In one embodiment of the present invention, the nutritional complementary food composition is characterized by the induction of a low glucose and insulin response in the subject receiving it.

In one embodiment of the present invention, a nutritional complementary food composition having a low glycemic index is obtained by reducing the amount of carbohydrate ingredient in any way.

In another aspect, the nutritional complementary food composition of the present invention comprises at least one low glycemic index ingredient.

In one embodiment, the nutritional composition for feeding according to the present invention contains one type of cereal flour or a mixture with it. In one embodiment, the cereal flour may be refined or whole grain. In a further embodiment, the cereal flour may be refined or whole grain flour made from maize, wheat, rice, oats, corn, or barley.

In one embodiment, the nutritional complementary food composition of the present invention comprises an amount of various types of cereal flour ranging from 20 to 90% by weight, for example from 20 to 70% by weight.

In one embodiment, if the nutritional complementary food composition is an infant cereal product, such as a complete infant cereal product, it contains an amount of various cereal flours ranging from 30 to 55 wt%. In one embodiment, it contains from 0 to 30 wt.% refined flour and from 0 to 55% various types of whole grain flour.

In one embodiment, if the nutritional complementary food composition is an infant cereal product, such as a standard infant cereal product, it contains an amount of different types of cereal flour ranging from 40 to 85 wt.% or from 50 to 90 wt. .%. In one embodiment, it contains from 30 to 50 wt.% refined flour and from 20 to 40% various types of whole grain flour.

In one embodiment, the nutritional complementary food composition of the present invention contains at least one carbohydrate ingredient with a low glycemic index.

In a further embodiment, the nutritional complementary food composition of the present invention comprises at least one carbohydrate ingredient selected from the group consisting of: resistant starches, amylose, sucrose, lactose, isomaltulose, maltitol, galactose, fructose, isomalt, xylitol, and polydextrose.

In one embodiment, the nutritional complementary food composition of the present invention contains sugar alone or mixtures with it.

In one embodiment, the total amount of sugars in the nutritional food composition according to the invention ranges from 0 to 30 wt.%, preferably from 0 to 20, for example from 5 to 18 wt.%.

In one embodiment, for example, if the product is a whole grain product for infants, the total amount of sugars in the nutritional complementary food composition according to the invention ranges from 0 to 30 wt.%, preferably from 2 to 25, for example from 5 to 25 wt. .%.

In one embodiment, for example, if the product is a standard infant cereal product, the total amount of sugars in the nutritional complementary food composition according to the invention ranges from 0 to 30 wt.%, preferably from 2 to 25, for example, from 5 to 20 wt. .%.

In another embodiment, the amount of added sugars in the nutritional complementary food composition ranges from 0 to 30% by weight, such as 1 to 20% by weight or 5 to 15% by weight.

In one embodiment, the nutritional complementary food composition of the present invention contains an amount of low glycemic index added sugars that ranges from 0 to 30% by weight, such as 1 to 20% by weight or 5 to 15% by weight. For example, a low glycemic index sugar may be selected from the group consisting of lactose, galactose, fructose, and isomaltulose.

In one embodiment, the nutritional complementary food composition of the invention comprises, or mixtures with, edible fat, for example, it contains vegetable oils (e.g., rapeseed oil, palm oil, corn oil, soybean oil, coconut oil, and/or sunflower oil) and/or fats derived from milk.

In a further embodiment, the complementary nutritional composition contains fats in an amount ranging from 8 to 20% by weight of the composition, eg in the range of 10 to 20% by weight, eg in the range of 10 to 17% by weight. or from 10 to 15 wt.%.

In one embodiment, the energy provided by the fats in the composition ranges from 22% to 40%, eg 27% to 38%, of the total calorie intake provided by the complementary feeding composition of the invention.

In one embodiment, the nutritional composition for feeding according to the present invention does not contain fat. In such an embodiment, the nutritional complementary food composition of the invention may be a standard cereal product as defined above.

In one embodiment, the nutritional composition for feeding according to the present invention contains dietary fiber or mixtures with it. In one embodiment, the total amount of dietary fiber in the nutritional complementary food composition according to the invention ranges from 0 to 25 wt.%, for example from 2 to 22 wt.%; for example from 2 to 12 wt.%, for example from 6 to 10 wt.%.

In another embodiment, if the complementary food composition is a complete infant cereal product, the amount of added fiber species in the complementary food composition ranges from 0 to 10% by weight, such as from 1 to 8% by weight, or from 1, 5 to 7 wt.%.

In a further embodiment, if the complementary food composition is a standard infant cereal product, the amount of added fiber species in the complementary food composition ranges from 0 to 20% by weight, such as 5 to 18% by weight.

In one embodiment, the nutritional composition for feeding according to the present invention contains a milk ingredient or mixtures with it.

In one embodiment, the nutritional complementary food composition contains a milk ingredient in an amount ranging from 0 to 35 wt.%, for example, from 0 to 30 wt.%, for example, from 1 to 25 wt.%, for example, from 5 to 25 wt. %.

In a further embodiment, the nutritional complementary food composition contains dairy ingredients having a GI less than or equal to 30 in an amount ranging from 0 to 35 wt%, such as 0 to 30 wt%, such as 1 to 25 wt%. , for example from 5 to 25 wt.%.

In one embodiment, the nutritional composition for feeding according to the present invention contains a legume or mixtures with it.

In one embodiment, the nutritional complementary food composition contains legumes in an amount ranging from 5 to 40% by weight, eg 8 to 30% by weight, eg 10 to 25% by weight.

In a further embodiment, the complementary nutritional composition comprises legumes having a GI less than or equal to 50 in an amount ranging from 5 to 40% by weight, eg 8 to 30% by weight, eg 10 to 25% by weight.

In one embodiment, the complementary nutritional composition of the present invention comprises or mixtures with the fruit of the plant.

In one embodiment, the complementary nutritional composition contains plant fruits in an amount ranging from 0 to 25% by weight, such as 1 to 18% by weight.

In a further embodiment, the complementary nutritional composition comprises plant fruits having a GI less than or equal to 70, such as less than or equal to 50, in an amount ranging from 0 to 20% by weight, such as from 1 to 15% by weight.

In one embodiment, the present invention provides a nutritional complementary food composition comprising:

- flour from cereals in an amount varying in the range from 20 to 90 wt.%;

- sugar in an amount ranging from 0 to 30 wt.%, for example from 0 to 20 wt.%, for example from 5 to 18 wt.%;

- added sugar with a low glycemic index in an amount ranging from 0 to 30 wt.%, for example from 1 to 20 wt.%, for example from 5 to 15 wt.%;

- fat in an amount ranging from 8 to 20 wt.% of the composition, for example in the range from 10 to 17 wt.%, for example from 10 to 15 wt.%;

- the total amount of dietary fiber in an amount varying in the range from 0 to 25 wt.%, for example from 2 to 25 wt.%;

- added fiber in an amount ranging from 0 to 20 wt.%;

- dairy ingredient in an amount ranging from 0 to 30 wt.%, for example from 1 to 25 wt.%, for example from 5 to 25 wt.%;

- legume in an amount varying in the range from 0 to 40 wt.%, for example from 5 to 40 wt.%;

- the fruit of the plant in an amount ranging from 0 to 25 wt.%, for example from 1 to 18 wt.%.

In one embodiment, the complementary nutritional composition described above is characterized by a low glycemic index and/or a low glycemic load. In one embodiment, the nutritional composition of the invention described above is an infant cereal product. In one embodiment, the complementary nutritional composition described above is characterized by inducing a low glucose and/or insulin response in the subject receiving it. In one embodiment, the above-described nutritional complementary feeding composition of the invention is for use in the treatment, prevention, and/or reduction in the risk of developing a disorder associated with metabolic syndrome manifesting later in life.

In one embodiment, the present invention provides a nutritional complementary food composition comprising:

- flour from cereals in an amount varying in the range from 20 to 70 wt.%, for example from 30 to 55 wt.% varieties of flour from cereals;

- sugar in an amount ranging from 0 to 30 wt.%, for example from 0 to 20 wt.%, for example from 5 to 18 wt.%;

- added sugar with a low glycemic index in an amount ranging from 0 to 30 wt.%, for example from 1 to 20 wt.%, for example from 5 to 15 wt.%;

- fat in an amount ranging from 8 to 20 wt.% of the composition, for example in the range from 10 to 17 wt.%, for example from 10 to 15 wt.%;

- the total amount of dietary fiber in an amount varying in the range from 2 to 12 wt.%, for example from 6 to 10 wt.%;

- added fiber in an amount ranging from 0 to 10 wt.%, for example from 1 to 8 wt.%, for example from 1.5 to 7 wt.%;

- dairy ingredient in an amount ranging from 0 to 35 wt.%, for example from 0 to 30 wt.%, for example from 1 to 25 wt.%, for example from 5 to 25 wt.%;

- legume in an amount ranging from 5 to 40 wt.%, for example from 8 to 30 wt.%, for example from 10 to 25 wt.%;

- the fruit of the plant in an amount ranging from 0 to 25 wt.%, for example from 1 to 18 wt.%.

In another embodiment, the present invention provides a nutritional complementary food composition comprising:

- flour from cereals in an amount varying in the range from 20 to 70 wt.%, for example from 30 to 55 wt.% varieties of flour from cereals, for example from 33 to 50 wt.%;

- sugar in an amount ranging from 0 to 30 wt.%, for example from 0 to 25 wt.%, for example from 5 to 25 wt.%, for example from 0 to 20 wt.%, for example from 5 to 18 wt. %;

- added sugar with a low glycemic index in an amount ranging from 0 to 30 wt.%, for example from 1 to 20 wt.%, for example from 5 to 15 wt.%;

- fat in an amount ranging from 8 to 20 wt.% of the composition, for example in the range from 10 to 17 wt.%, for example from 10 to 15 wt.%;

- the total amount of dietary fiber in an amount varying in the range from 2 to 12 wt.%, for example from 6 to 10 wt.%;

- added fiber in an amount ranging from 0 to 10 wt.%, for example from 1 to 8 wt.%, for example from 1.5 to 7 wt.%;

- dairy ingredient in an amount ranging from 0 to 35 wt.%, for example from 0 to 30 wt.%, for example from 1 to 25 wt.%, for example from 5 to 25 wt.%;

- legume in an amount ranging from 5 to 40 wt.%, for example from 5 to 40 wt.%, for example from 8 to 30 wt.%, for example from 10 to 25 wt.%;

- the fruit of the plant in an amount ranging from 0 to 25 wt.%, for example from 1 to 18 wt.%.

In a further embodiment, the present invention provides a nutritional complementary food composition comprising:

- flour from cereals in an amount varying in the range from 33 to 50 wt.%;

- sugar in an amount varying in the range from 5 to 25 wt.%;

- added sugar with a low glycemic index in an amount ranging from 5 to 15 wt.%;

- fat in an amount varying in the range from 10 to 17 wt.%;

- the total amount of dietary fiber in an amount ranging from 6 to 10 wt.%;

- added fiber in an amount ranging from 0 to 10 wt.%, for example from 1 to 8 wt.%, for example from 1.5 to 7 wt.%;

- dairy ingredient in an amount ranging from 5 to 25 wt.%;

- legume in an amount ranging from 5 to 40 wt.%, for example from 5 to 40 wt.%, for example from 8 to 30 wt.%, for example from 10 to 25 wt.%;

- the fruit of the plant in an amount ranging from 0 to 25 wt.%, for example from 1 to 18 wt.%.

In a further embodiment, the present invention provides a nutritional complementary food composition comprising:

- flour from cereals in an amount varying in the range from 33 to 50 wt.%;

- sugar in an amount varying in the range from 5 to 25 wt.%;

- added sugar with a low glycemic index in an amount ranging from 5 to 15 wt.%;

- fat in an amount varying in the range from 10 to 17 wt.%;

- the total amount of dietary fiber in an amount ranging from 6 to 10 wt.%;

- added fiber in an amount ranging from 1.5 to 7% by weight;

- dairy ingredient in an amount ranging from 5 to 25 wt.%;

- legume in an amount varying in the range from 10 to 25 wt.%;

- the fruit of the plant in an amount varying in the range from 1 to 18 wt.%;

- moreover, the nutritional composition for complementary foods contains from 0 to 30 wt.% refined flour from cereals and from 0 to 55% of various types of whole grain flour from cereals.

In a further embodiment, the present invention provides a nutritional complementary food composition comprising:

- flour from cereals in an amount varying in the range from 33 to 50 wt.%;

- sugar in an amount varying in the range from 5 to 25 wt.%;

- added sugar with a low glycemic index in an amount ranging from 5 to 15 wt.%;

- fat in an amount varying in the range from 10 to 17 wt.%;

- the total amount of dietary fiber in an amount ranging from 6 to 10 wt.%;

- added fiber in an amount ranging from 0 to 10 wt.%, for example from 1 to 8 wt.%, for example from 1.5 to 7 wt.%;

- dairy ingredient in an amount ranging from 5 to 25 wt.%;

- legume in an amount varying in the range from 10 to 25 wt.%;

- the fruit of the plant in an amount varying in the range from 1 to 18 wt.%;

- moreover, the nutritional composition for complementary foods contains from 0 to 30 wt.% refined flour from cereals and from 0 to 55% of various types of whole grain flour from cereals.

In a further embodiment, the present invention provides a nutritional complementary food composition comprising:

- flour from cereals in an amount varying in the range from 33 to 50 wt.%;

- sugar in an amount varying in the range from 5 to 25 wt.%;

- added sugar with a low glycemic index in an amount ranging from 5 to 15 wt.%;

- fat in an amount varying in the range from 10 to 17 wt.%;

- the total amount of dietary fiber in an amount ranging from 6 to 10 wt.%;

- added fiber in an amount ranging from 1.5 to 7% by weight;

- dairy ingredient in an amount ranging from 5 to 25 wt.%;

- legume in an amount varying in the range from 10 to 25 wt.%;

- the fruit of the plant in an amount ranging from 0 to 25 wt.%, for example from 1 to 18 wt.%.

- moreover, the nutritional composition for complementary foods contains from 0 to 30 wt.% refined flour from cereals and from 0 to 55% of various types of whole grain flour from cereals.

In a further embodiment, the present invention provides a nutritional complementary food composition comprising:

- flour from cereals in an amount varying in the range from 33 to 50 wt.%;

- sugar in an amount varying in the range from 5 to 25 wt.%;

- added sugar with a low glycemic index in an amount ranging from 5 to 15 wt.%;

- fat in an amount varying in the range from 10 to 17 wt.%;

- the total amount of dietary fiber in an amount ranging from 6 to 10 wt.%;

- added fiber in an amount ranging from 1.5 to 7% by weight;

- dairy ingredient in an amount ranging from 5 to 25 wt.%;

- legume in an amount ranging from 5 to 40 wt.%, for example from 5 to 40 wt.%, for example from 8 to 30 wt.%, for example from 10 to 25 wt.%;

- the fruit of the plant in an amount varying in the range from 1 to 18 wt.%;

- moreover, the nutritional composition for complementary foods contains from 0 to 30 wt.% refined flour from cereals and from 0 to 55% of various types of whole grain flour from cereals.

In one embodiment, the seven complementary nutritional compositions described above are characterized by a low glycemic index and/or a low glycemic load. In one embodiment, the above-described nutritional composition for feeding according to the invention is a complete cereal product for infants. In one embodiment, the complementary nutritional composition described above is characterized by inducing a low glucose and/or insulin response in the subject receiving it. In one embodiment, the above-described nutritional complementary feeding composition of the invention is for use in the treatment, prevention, and/or reduction in the risk of developing a disorder associated with metabolic syndrome manifesting later in life.

In another embodiment, the present invention provides a nutritional complementary food composition comprising:

- flour from cereals in an amount varying in the range from 20 to 90 wt.%, for example from 40 to 85 wt.% varieties of flour from cereals;

- total sugar in an amount ranging from 0 to 30 wt.%, for example from 0 to 20 wt.%, for example from 5 to 18 wt.%;

- added sugar with a low glycemic index in an amount ranging from 0 to 30 wt.%, for example from 1 to 20 wt.%, for example from 5 to 15 wt.%;

- fat in an amount ranging from 0 to 10 wt.% of the composition, for example in the range from 0 to 8 wt.%, for example from 0 to 5 wt.%;

- the total amount of dietary fiber in an amount varying in the range from 0 to 25 wt.%, for example from 2 to 22 wt.%;

- added fiber in an amount ranging from 0 to 20 wt.%, for example from 5 to 18 wt.%;

- legume in an amount ranging from 5 to 40 wt.%, for example from 8 to 30 wt.%, for example from 10 to 25 wt.%;

- the fruit of the plant in an amount ranging from 0 to 25 wt.%, for example from 1 to 18 wt.%.

In another embodiment, the present invention provides a nutritional complementary food composition comprising:

- flour from cereals in an amount varying in the range from 20 to 90 wt.%, for example from 40 to 85 wt.%, for example from 50 to 90 wt.% varieties of flour from cereals;

- total sugar in an amount ranging from 0 to 30 wt.%, for example from 5 to 25 wt.%, for example from 0 to 20 wt.%, for example from 2 to 20 wt.%, for example from 5 to 18 wt. .%;

- added sugar with a low glycemic index in an amount ranging from 0 to 30 wt.%, for example from 1 to 20 wt.%, for example from 5 to 15 wt.%;

- fat in an amount ranging from 0 to 10 wt.% of the composition, for example in the range from 0 to 5 wt.%;

- the total amount of dietary fiber in an amount varying in the range from 0 to 25 wt.%, for example from 2 to 22 wt.%;

- added fiber in an amount ranging from 0 to 20 wt.%, for example from 5 to 18 wt.%;

- legume in an amount ranging from 5 to 40 wt.%, for example from 8 to 30 wt.%, for example from 10 to 25 wt.%;

- the fruit of the plant in an amount ranging from 0 to 25 wt.%, for example from 1 to 18 wt.%.

In a further embodiment, the present invention provides a nutritional complementary food composition comprising:

- flour from cereals in an amount varying in the range from 50 to 90 wt.%;

- total sugar in an amount ranging from 5 to 18% by weight;

- added sugar with a low glycemic index in an amount ranging from 5 to 15 wt.%;

- fat in an amount ranging from 0 to 10 wt.% of the composition, for example in the range from 0 to 5 wt.%;

- the total amount of dietary fiber in an amount ranging from 2 to 22 wt.%;

- added fiber in an amount ranging from 0 to 20 wt.%, for example from 5 to 18 wt.%;

- legume in an amount ranging from 5 to 40 wt.%, for example from 8 to 30 wt.%, for example from 10 to 25 wt.%;

- the fruit of the plant in an amount ranging from 0 to 25 wt.%, for example from 1 to 18 wt.%.

moreover, the nutritional composition for feeding contains from 30 to 50 wt.% refined flour from cereals and from 20 to 40% of various types of whole grain flour from cereals.

In a further embodiment, the present invention provides a nutritional complementary food composition comprising:

- flour from cereals in an amount varying in the range from 50 to 90 wt.%;

- total sugar in an amount ranging from 5 to 18% by weight;

- added sugar with a low glycemic index in an amount ranging from 5 to 15 wt.%;

- fat in an amount ranging from 0 to 10 wt.% of the composition, for example in the range from 0 to 5 wt.%;

- the total amount of dietary fiber in an amount ranging from 2 to 22 wt.%;

- added fiber in an amount ranging from 5 to 18% by weight;

- legume in an amount varying in the range from 10 to 25 wt.%;

- the fruit of the plant in an amount varying in the range from 1 to 18 wt.%;

moreover, the nutritional composition for feeding contains from 30 to 50 wt.% refined flour from cereals and from 20 to 40% of various types of whole grain flour from cereals.

In one embodiment, the three complementary nutritional compositions described above are characterized by a low glycemic index and/or a low glycemic load. In one embodiment, the nutritional complementary food composition of the invention described above is a standard infant cereal product. In one embodiment, the complementary nutritional composition described above is characterized by inducing a low glucose and/or insulin response in the subject receiving it. In one embodiment, the above-described nutritional complementary feeding composition of the invention is for use in the treatment, prevention, and/or reduction in the risk of developing a disorder associated with metabolic syndrome manifesting later in life.

In a further embodiment, the present invention provides a nutritional complementary food kit that comprises a nutritional complementary food composition comprising:

- flour from cereals in an amount varying in the range from 20 to 70 wt.%, for example from 30 to 55 wt.% varieties of flour from cereals, for example from 33 to 50 wt.%;

- sugar in an amount ranging from 0 to 30 wt.%, for example from 0 to 25 wt.%, for example from 5 to 25 wt.%, for example from 0 to 20 wt.%, for example from 5 to 18 wt. %;

- added sugar with a low glycemic index in an amount ranging from 0 to 30 wt.%, for example from 1 to 20 wt.%, for example from 5 to 15 wt.%;

- fat in an amount ranging from 8 to 20 wt.% of the composition, for example in the range from 10 to 17 wt.%, for example from 10 to 15 wt.%;

- the total amount of dietary fiber in an amount varying in the range from 2 to 12 wt.%, for example from 6 to 10 wt.%;

- added fiber in an amount ranging from 0 to 10 wt.%, for example from 1 to 8 wt.%, for example from 1.5 to 7 wt.%;

- dairy ingredient in an amount ranging from 0 to 35 wt.%, for example from 0 to 30 wt.%, for example from 1 to 25 wt.%, for example from 5 to 25 wt.%;

- legume in an amount ranging from 5 to 40 wt.%, for example from 5 to 40 wt.%, for example from 8 to 30 wt.%, for example from 10 to 25 wt.%;

- the fruit of the plant in an amount varying in the range from 0 to 25 wt.%, for example from 1 to 18 wt;

OR

- flour from cereals in an amount varying in the range from 20 to 90 wt.%, for example from 40 to 85 wt.%, for example from 50 to 90 wt.% varieties of flour from cereals;

- total sugar in an amount ranging from 0 to 30 wt.%, for example from 5 to 25 wt.%, for example from 0 to 20 wt.%, for example from 2 to 20 wt.%, for example from 5 to 18 wt. .%;

- added sugar with a low glycemic index in an amount ranging from 0 to 30 wt.%, for example from 1 to 20 wt.%, for example from 5 to 15 wt.%;

- fat in an amount ranging from 0 to 10 wt.% of the composition, for example in the range from 0 to 8 wt.%, for example from 0 to 5 wt.%;

- the total amount of dietary fiber in an amount varying in the range from 0 to 25 wt.%, for example from 2 to 22 wt.%;

- added fiber in an amount ranging from 0 to 20 wt.%, for example from 5 to 18 wt.%;

- legume in an amount ranging from 5 to 40 wt.%, for example from 8 to 30 wt.%, for example from 10 to 25 wt.%;

- the fruit of the plant in an amount varying in the range from 0 to 25 wt.%, for example from 1 to 18 wt;

- OR

any of the above described complementary foods according to the present invention.

Compositions for Use - Disorders

The present invention relates to a nutritional complementary food composition of the present invention for use in the treatment, prevention and/or reduction of the risk of later life development of a disorder associated with metabolic syndrome.

In one embodiment, the invention relates to a nutritional complementary feeding composition of the present invention for use in preventing and/or reducing the risk of later life development of a disorder associated with metabolic syndrome.

As used herein, the term "disorder associated with metabolic syndrome" refers to one or more disorders associated with metabolic syndrome. Examples of such disorders include diabetes, such as diabetes mellitus, impaired glucose tolerance, impaired fasting glucose, insulin resistance, hypertension, dyslipidemia, overweight, obesity (especially central obesity) and microalbuminuria. These disorders are usually the result of dysregulation of glucose homeostasis. For example, the disorder may be selected from the group consisting of diabetes mellitus, impaired glucose tolerance, impaired fasting glucose, insulin resistance, hypertension, overweight, and obesity (especially central obesity).

Thus, in one embodiment, the present invention provides a composition for use according to the present invention, wherein the disorder is selected from the group consisting of diabetes mellitus, impaired glucose tolerance, impaired fasting glucose, insulin resistance, hypertension, dyslipidemia, body weight, obesity (especially central obesity) and microalbuminuria.

In other embodiments, the present invention relates to a composition for use in accordance with the present invention, the use being intended to improve insulin sensitivity, achieve normal body weight, and/or prevent overweight later in life.

The term "later in life" in the context of the present invention refers to the time period after childhood, ie after the age of 12 years. In embodiments of the present invention, the disorder associated with the metabolic syndrome occurs after the age of 12 years or, for example, after the age of 15 years, for example, after the age of 18 years, for example, after the age of 25 years, after the age of 30 years, after the age of 35 years.

Thus, a further embodiment of the invention relates to a composition for use according to the invention, the use being for the treatment, prevention and/or reduction of the risk of developing a disorder associated with the metabolic syndrome manifesting later in life with an adipogenic diet.

In the context of the present invention, the term "adipogenic diet" refers to a diet that results in an increase in body fat in an individual. Generally, an excess of energy intake leads to an increase in fat mass, so one example of an adipogenic diet is a diet in which calorie intake exceeds the individual's caloric requirement. Other examples of an adipogenic diet include the typical Western diet, also known as the Western-style diet or the standard American diet. Another example of an adipogenic diet is a diet that is characterized by a fat content that exceeds the dietitian's recommended value of 30% energy from fat, a diet high in sugars, and/or a diet in which caloric intake exceeds the individual's caloric requirement.

Thus, it appears that a composition for use according to the invention, when administered early in life (e.g., an infant over 4 months of age or a toddler) will protect that individual if and when said individual later in life (e.g., adulthood) , or, for example, after 18, after 20, after 25, after 30 years of life) will follow an adipogenic diet. By protected is meant that glucose homeostasis and/or insulin sensitivity is not or is not impaired to the same extent. Without being bound by theory, it has been hypothesized that use of the composition of the present invention during nursing modulates metabolic pathways.

In other embodiments, the present invention relates to a composition for use in accordance with the present invention, wherein the use is for improving insulin sensitivity, achieving normal body weight, and/or preventing overweight.

Composition for use - target groups

The composition for use in accordance with the invention is intended for administration to an infant over 4 months of age or a young child.

In one embodiment, an infant or young child, for example, is born to a mother who herself suffered or is suffering from one or more disorders associated with metabolic syndrome, for example, one or more disorders that are selected from the group consisting of diabetes mellitus , impaired glucose tolerance, impaired fasting glucose, insulin resistance, hypertension, dyslipidemia, overweight, obesity (especially central obesity) and microalbuminuria, or gestational diabetes.

In a further embodiment, the infant or young child is believed to be at risk of developing one or more disorders associated with the metabolic syndrome, for example, due to an inherited risk, such as a family history risk, low birth weight, or height limitation.

In one embodiment, the composition for use is for administration to an infant over 4 months of age or a young child, regardless of birth weight.

In another embodiment of the present invention, the composition for use in accordance with the invention is for administration to an infant older than 4 months, such as 6 months, or a young child whose birth weight was normal. In another embodiment, the birth weight of the infant or young child was underweight or overweight.

In a further embodiment, the present invention relates to a composition for use in accordance with the invention, wherein the composition is for administration to an infant older than 4 months, such as 6 months, or a young child who is experiencing catch-up growth after a period of growth restriction.

In a further embodiment, the present invention relates to a composition for use according to the invention, wherein the composition is for administration to an infant over 4 months of age, such as 6 months of age, or a young child who does not experience catch-up growth after a period of growth restriction.

In another further embodiment, the present invention relates to a composition for use according to the invention, wherein the composition is for administration to an infant over 4 months old, such as 6 months old, or a young child who was born at a normal weight and had an unrestricted food intake and a normal growth during infancy and/or early childhood.

Dosing regimen

The invention relates to the surprising finding that administration of low glycemic index nutritional compositions to an infant or young child between 4, e.g. 6 months to 5, e.g. 2 years of age, can protect against later life development of disorders associated with metabolic syndrome.

A complementary feeding composition for use in accordance with the invention is intended to be administered to an infant or young child between 4 and 60 months of age. In other embodiments, administration is for a period of time from 6 months to 36 months, or 24 months, such as up to 18 months, such as up to 12 months.

In one embodiment of the present invention, a composition for use in accordance with the invention is administered to an infant or young child during the weaning period.

Complementary feeding refers to the period in an infant's or young child's life when they transition from exclusive milk feeding (eg, breastfeeding) to a mixed diet of breast milk (or substitutes) and solid foods. This period depends on the individual characteristics of the infant or young child, but generally falls within the range of 4 months to 18 months, eg 6 to 18 months.

In one embodiment of the present invention, a complementary feeding composition for use according to the invention is intended to be administered to an infant or young child between the ages of 4 and 60 months, and the administration should last at least 3 months, such as 6 months, or 9 months, or 12 months .

In the aforementioned period, the administration may be, for example, intermittent, or, for example, on average once a day during the specified period, or, for example, once every two days during the specified period, or, for example, at least once a day for the specified period, or, for example, at least once a day for the specified period. the specified period.

In another embodiment of the present invention, the administration of the composition is for a shorter period of time within the time period mentioned above, for example, an average of once a day for at least six weeks in the specified time period; for example, an average of once a day for 3, 6, 8, 9 months during the specified time period.

Alternatively, the administration can be, for example, on average once every two days over a period of at least six weeks over a period of 4 months to 60 months, for example, on an average once every two days over a period of 3, 6, 8 or 9 months within the specified time period.

In other embodiments, the implementation of the present invention relates to the use in accordance with the present invention, and the composition is administered at least once a day for at least 1 month.

In one embodiment of the present invention, the nutritional complementary food composition provides the receiving infant or young child with at least 10%, for example, 20%, or 30%, or 50%, or 70%, or 80% of the total daily caloric intake.

In another embodiment, the complementary nutritional composition provides the receiving infant or young child with a total daily caloric intake.

Forms of nutritional composition

Therapeutic nutrition is a special class of nutritional compositions designed to provide control of certain conditions through diet. Therapeutic nutrition meets certain criteria which are established and regulated by Section 5 [360ee](b)(2)(D) of the Orphan Drugs Act of 1983. Therapeutic nutrition may be presented in any suitable form as described below.

Thus, one embodiment of the invention relates to a nutritional complementary food composition according to the invention, the nutritional composition being a health food.

The nutritional composition for complementary foods according to the invention may be in any suitable form.

The form of the nutritional complementary food composition for use in accordance with the invention may be adapted to the age of the infant or young child to whom it is administered.

Examples of forms of nutritional composition suitable for infants include formula for feeding children, milk formula for children from 1 to 3 years old, cereal product for infants or baby food.

Examples of forms suitable for infants and/or young children include ready-to-drink compositions, liquid foods, milk drinks, milk shakes, milk biscuits, yogurts, soups, desserts, puddings, bars such as cereal bars, extruded cereal products, cereals, drinks and various types of baby food.

If the nutritional complementary food composition is an infant cereal product, it may contain at least 0.48 g/100 kJ of a protein source, not more than 1.1 g/100 kJ of a lipid source and a carbohydrate source.

Infant cereal products are known in the art. Infant cereal products are cereal-containing compositions intended for administration to infants. They usually need to be administered using a spoon and, for example, they can be presented as a dry cereal product for babies. Ready-to-eat cereal products for infants are also within the scope of the present invention. The Codex Alimentarius offers guidance on what ingredients an infant cereal product should contain. Infant cereal products may be intended to be diluted in water or milk.

In general, the calorie density and the amounts and types of proteins, carbohydrates and lipids present in an infant cereal product must be carefully tailored to the needs of the infant and depend on the stage of development and age of the infant.

It is well known that the nutritional requirements of an infant change with the development and age of an infant, and the composition of an infant cereal product ideally reflects this change.

Therefore, a standard infant cereal product (to be prepared with milk) according to the present invention, intended for administration to infants aged 4-6 months, may have an energy value of 220-240 kJ/15 g, 0.8-1.2 g/15 g protein source, 0.1-0.3 g fat source and 12.3-12.7 g/15 g carbohydrate source. Such an infant cereal product may contain, for example, rice flour, maize maltodextrin, vitamin C and iron.

A standard infant cereal product (for preparation with milk) according to the present invention, intended for administration to infants aged 6-12 months, may have an energy value of 220-240 kJ/15 g, 1.5-1.9 g/ 15 g protein source, 0.2-0.4 g fat source and 11.1-11.5 g/15 g carbohydrate source. Such an infant cereal product may contain, for example, wheat flour, wheat grits, iron, vitamin C, niacin, vitamin B6, thiamine, and maize maltodextrin.

Therefore, an infant cereal product intended to be prepared with milk according to the present invention, intended to be administered to infants from the age of 4-6 months, can have an energy value of 400-420 kcal per 100 g 100 g, 10-16 g source protein, 7-17 g fat source and 50-75 g carbohydrate source. Such an infant cereal product may contain, for example, rice flour, maize maltodextrin, vitamin C and iron.

An infant cereal product of the present invention for administration to infants aged 6-12 months may have some energy value. Such an infant cereal product may contain, for example, wheat flour, wheat grits, iron, vitamin C, niacin, vitamin B6, thiamine, and maize maltodextrin.

Infant cereal products may be made from one or more ground cereals, which may comprise at least 25% by weight of the final formula on a dry matter basis.

The infant cereal products of the present invention are preferably prepared from a single grain, such as a rice grain or a wheat grain, since single grain compositions are less likely to cause allergic reactions.

As a general rule, infant cereal products must be mixed with water or milk before consumption. For example, 15 g of an infant cereal product of the present invention may be mixed with 45 ml (in the case of a complete infant cereal product) of water or 90 ml of milk (in the case of a standard infant cereal product), respectively.

Combination of descriptions

It should be noted that embodiments and features described in the context of one aspect of the present invention are also applicable to other aspects and embodiments of the invention, mutatis mutandis.

Compositions for use in accordance with the invention are described herein using various parameters such as ingredients, nutritional composition forms, applications, target groups, etc. It should be noted that the embodiments, features, and illustrative embodiments described in the context of one of the composition parameters for use in accordance with the invention may also be combined with other embodiments, features, and illustrative embodiments described in the context of another parameter, unless explicitly stated otherwise.

All patent and non-patent references cited in this application are hereby incorporated by reference in their entirety.

The present invention will be further described in detail in the following non-limiting examples.

Experimental section

Example 1

The effect of diets during the feeding period with different GIs on subsequent adult blood glucose levels was investigated using a rat model of intrauterine growth retardation (IUGR). The IUGR model was used as a sensitive model for subsequent impaired glucose homeostasis (see Shankhalili Y. et Al, 2010, “Comparison of two models on intrauterine growth restriction for early catch up growth and later development of glucose intolerance and obesity in rats” (Am J. Physiol Regul Interg Comp Physiol 298; R141-R146).

Study scheme:

IUGR was induced in Sprague Dawley (SD) rats by 50% food restriction in the last 10 days of pregnancy. During the suckling period, the rat pups were fed by their mothers. At the end of the lactation period (age 21 days), 40 male rat pups from the IUGR group and twenty male rat pups from the non-IUGR group (comparison group) were separated from their mothers.

IUGR rats were randomly divided into two groups (20/group) with similar body weight and similar number of pups from each litter. Pups were then fed ad libitum from 21 to 52 days of age (Phase I) on a modified semi-synthetic AIN96 complementary diet with 15% glucose as an energy source (E) and either 15% galactose E (galactose diet: Group G IUGR) or 15% starch E (control diet: non-IUGR groups C and IUGR groups C). The micronutrient and fiber content and macronutrient energy distribution of both complementary diets were similar with 20% protein E, 17% fat E and 67% CHO E with or without 15% galactose E as an isocaloric replacement for cornstarch in the control. diet (table 1).

All animals were then fed an ad libitum high fat diet (Kliba 2126, 45% fat E) until 155 days of age (phase II). The figure 1 shows the scheme of the study.

During the study, food intake and body weight were recorded (2-3 times a week). Blood samples for baseline determination (8 hours after food deprivation) were taken from the tail vein at 52 and 141 days of age for glucose and insulin analysis.

For the two diets given to these groups, a rat glycemic load substitute (SGL) was calculated based on a daily intake of 15 g. For the control diet, SGL = 7.1, while for the galactose diet, SGL = 5.76, resulting in 19. 2% reduction in SGL compared to the control diet.

Table 1 - composition of diets

Ingredient Galactose Diet Control Diet Starch from cornmeal 33 48 K-casein twenty twenty D-glucose fifteen fifteen Galactose fifteen - Soybean oil 7 7 Cellulose 5 5 Mixture of minerals 3.5 3.5 Vitamin Blend one one Other 0.5 0.5 Total (wet weight) 100 100 kcal/100g wet mix 360.0 360.0 The energy value, % Protein twenty twenty CHO 62 62 Fat eighteen eighteen

results

Body weight and energy intake

Birth weight in both IUGR groups was significantly lower than in the non-IUGR group. However, growth in the IUGR group was faster than in the non-IUGR group during the first week of the suckling period (catch-up growth), and all groups had similar body weights from 10 days of age (Figure 2). The total caloric intake (Figure 3) and body weight (Figure 4) of all groups were also similar during the complementary feeding intervention period (Phase I) and the follow-up period (Phase II).

Baseline blood glucose and insulin levels

It can be seen from the results that both IUGR groups had lower baseline blood glucose and insulin levels relative to the non-IUGR group at the end of the complementary feeding period (age 51 days), indicating an altered glucose metabolism in IUGR rats and no immediate effect of the complementary diet.

Surprisingly, the IUGR group that was previously fed galactose (a low GI sugar) only during the feeding period (21-51 days of age) had lower blood glucose levels in adulthood (at 142 days of age) compared to the control group. IUGR fed a higher starch (higher GI carbohydrate) complementary diet (Figure 4). Values in the group that received galactose during the complementary feeding period normalized and were similar to those in the non-IUGR comparison group. A similar trend was observed in the insulin response at the age of 142 days (figure 5).

In conclusion, these results show for the first time that complementary diets with different GI, GL have an impact on the subsequent control of blood glucose / insulin levels in adulthood and, therefore, on the risk of developing metabolic diseases. Therefore, these results suggest a beneficial programming effect of low glycemic load and/or low glycemic index complementary foods on the subsequent control of glucose homeostasis and the risk of developing type 2 diabetes and other metabolic diseases later in life.

Example 2

An example of an infant cereal prepared with water (wt %).

A traditional infant cereal to be diluted with water is prepared according to the following formula: wheat flour 45% (40.1 g CHO), skim milk 26% (14.6 g CHO), butter 7%, glucose 6%, sucrose 15 %, vitamin and minerals 1% GI (calculated from the GI of the ingredients) of this example is 70, and the GL is 24.6.

Glycemic Load Calculation (serving size 50 g): GL=24.6 [GL= ((40.1/2 x 71) + (14.6/2 x 32) + (6.0/2 x 100) + ( 15/2x68)/100]

An appropriate infant cereal product according to the present invention can be prepared according to the following formulation using methods known to one skilled in the art: wheat flour 43% (38.3 g CHO), added lactose 15%, skim milk 26% (14.6 g CHO ), oil 13%, sucrose 2%, vitamins and minerals 1%. The GI of this example is 63 and the GL is 20.

Glycemic Load Calculation (serving size 50g): GL 20= [GL= ((38.3/2 x 71) + (14.6/2 x 32) + (15/2 x 46)+(2/2x68) )/100]

Example 3

An example of an infant cereal product prepared with milk (wt %).

A traditional infant cereal to be diluted with milk is prepared according to the following recipe: rice flour 75% (71 g CHO), glucose 7%, sucrose 15%, banana 2% (1.4 g CHO), vitamins and minerals 1% .

Glycemic Load Calculation (serving size 25 g): 21-[GL= ((71/4 x 85) + (7/4 x 100) + (15/4 x 68) + (1.4/4 x 61)) /100]

An appropriate infant cereal product according to the present invention can be prepared according to the following formulation using methods known to the person skilled in the art: rice flour 66% (62.5 g CHO), sucrose 2%, galactose 20%, banana 4% (1.4 g CHO), fat 5%, fiber 2.0%, vitamins and minerals 1%.

Glycemic Load Calculation (serving size 25g): 16 -[GL= ((62.5/4 x 71) + (2/4 x 68) + (20/4 x 20) + (2.8/4 x 61) ))/100]

Example 4

Cereal product for infants to be prepared with water (wt.%)

A cereal product for infants to be diluted with water is prepared according to the following formula: 23% refined wheat flour with 4% fiber (20 g available CHO with GI 71), 20% whole grain wheat flour with 8.6% fiber (14 g available CHO with GI 71), 14% red lentils with 11% fiber (8.2 g available CHO with GI 26), 15% skim milk (8.4 g CHO, GI 32), 12% fat (no GI), 11% sucrose (GI 68), 4% prebiotic (no GI), vitamins and minerals 1% (no GI) (serving size = 50 g powder + 150 ml water). Total sugar content: 20% by weight

Glycemic Load Calculation (serving size 50 g): GL=18 [GL= ((20/2 x 71) + (14/2 x 71) + (8.2/2 x 26) + (8.4/2 x 32) + (11/2 x 68)) /100]

Example 5

Cereal product for infants to be prepared with water (wt.%)

A cereal product for infants to be diluted with water is prepared according to the following formula: 24% refined wheat flour with 4% fiber (21 g available CHO with GI 71), 15% whole grain wheat flour with 8.6% fiber (10.5 g available CHO with GI 71), 14% red lentils with 11% fiber (8.2 g available CHO with GI 26), 15% skim milk (8.4 g CHO, GI 32), 15% fat (no GI), 4% prebiotic (no GI), 4% lactose (GI 46), 8% dry apple with 15% fiber (available CHO 5.8 with GI 29), vitamins and minerals 1% (no GI) (serving size = 50 g powder + 150 ml of water). Total sugar content: 19% by weight

Calculating the glycemic load (serving size 50 g) gives: GL=15.4

[GL= ((21/2 x 71) + (10.5/2 x 71) + (8.2/2 x 26) + (8.4/2 x 32) + (4/2 x 46) + (5.8/2x29)) / 100]

Comparison example 6

Cereal product for infants to be prepared with water (wt.%)

A traditional infant cereal to be diluted with water is prepared according to the following formula: 52% refined wheat flour with 4% fiber (43% available CHO with GI 70), 26% skimmed milk (14.6 g available CHO, GI 36) , 6% fat (no GI), 15% sucrose (GI 68), vitamins and minerals 1% (no GI). (Serving size = 50 g powder + 150 ml water). Total sugar content: 30% by weight.

Glycemic load calculation gives: GL=22.7

GL= ((43/2 x 71) + (14.6/2 x 32) + (15/2 x 68))/ 100

Example 7

Cereal product for infants to be prepared with water (wt.%)

A cereal product for infants to be diluted with water is prepared according to the following formula: 27% refined wheat flour with 4% fiber (24 g available CHO with GI 71), 20% whole grain wheat flour with 8.6% fiber (14 g available CHO with GI 71), 14% red lentils with 11% fiber (8.2 g available CHO with GI 26), 15% skim milk (8.4 g CHO, GI 32), 12% fat (no GI), 11% sucrose (GI 68), vitamins and minerals 1% (no GI) (serving size = 50 g powder + 150 ml water). Total sugar content: 20% by weight.

Calculating the glycemic load (serving size 50 g) gives: GL=19.6 [GL= ((24/2 x 71) + (14/2 x 71) + (8.2/2 x 26) + (8.4 /2 x 32) + (11/2 x 68)) /100]

Example 8

Cereal product for infants to be prepared with water (wt.%)

A cereal product for infants to be diluted with water is prepared according to the following formula: 28% refined wheat flour with 4% fiber (25 g available CHO with GI 71), 15% whole grain wheat flour with 8.6% fiber (10.5 g available CHO with GI 71), 14% red lentils with 11% fiber (8.2 g available CHO with GI 26), 15% skim milk (8.4 g CHO, GI 32), 15% fat (no GI), 4% lactose (GI 46), 8% dry apple with 15% fiber (available CHO 5.8 GI 29), vitamins and minerals 1% (no GI) (serving size = 50 g powder + 150 ml water). Total sugar content: 19% by weight.

Glycemic load calculation gives: GL=16.8

[GL= ((25/2 x 71) + (10.5/2 x 71) + (8.2/2 x 26) + (8.4/2 x 32) + (4/2 x 46) + (5.8/2x29)) / 100]

Although due to differences among species, SGL and GL differ in their absolute values, it should be noted that a decrease in GL results in a decrease of 18.5% and 33% when comparing Comparative Example 6 with Example 4 and 5, respectively. Thus, this demonstrates a decrease in GL at least comparable to that observed in rats with SGL when switching from traditional products to products according to the invention.

Example 9

Two complete infant cereal compositions of the present invention (Prototype 1 and Prototype 2) were compared in a clinical trial with a standard complete infant cereal product.

The study design was randomized, single center, double-blind, cross-over, with three test meals (an existing infant cereal standard and 2 prototype infant cereals). Table 2 below shows the composition of infant cereals.

Table 2 - Major macronutrient composition of tested infant cereal products (g/100g powder)

Reference Prototype 1 Prototype 2 Refined wheat flour (starch) 40.5 16 15.5 Wheat whole grain starch 19.9 14.7 glucose and maltose 20.5 8.0 8.3 sucrose 11.0 isomaltulose 5.0 red lentils 14.0 14.0 Skimmed milk 27.0 14.8 14.4 (of which lactose) (15.1) (8.2) (8.0) Added fiber 4.0 4.0 Added Fat 9.0 12.0 15.3 Dried plant fruit* 8.0 Added fructose 2.7 GL (50 g serving) 26 twenty 17

*2.1 g sucrose and 3.6 g fructose

The total sugar content (including milk lactose and sugars from fruits of plants) of the tested dishes is; 38% in the comparison diet, 27.3% in prototype 1 and 27% in prototype 2.

Twenty healthy males aged 21-45 years with a BMI of 22.3 ± 2.03 kg/m2 consumed all 3 of the study infant cereal products after overnight fasting at random with an interval of at least 3 days between tests. The study was carried out in accordance with the international standard ISO 26642, 2010.10.01 for the glycemic index. Study meals were prepared with 75 g of infant cereal powder diluted with 225 ml of pre-boiled warm water (40°C) and consumed within 10 minutes along with 250 ml of water. Fingerstick capillary blood samples were taken on an empty stomach (-10 and 0 minutes before taking the test meals) and 15, 30, 45, 60, 90, 120, 150, and 180 minutes after the start of the test meals.

The level of glucose in capillary blood was analyzed using Cobas, using Roche GLUC2 (04657527, Switzerland). Serum insulin was analyzed using the AlphaLISA® Human Insulin Immunoassay Kit, PerkinElmer Inc.

Incremental area under the curve (IAUC) of postprandial 2-hour glucose and insulin was calculated using the trapezoidal rule. The results of the postprandial increase in glucose and insulin responses are presented in figures 6-7, and the 2-hour IAUC relative to the reference product is presented in figures 8-9.

The results of the clinical trial clearly demonstrate the benefit of the reformulated infant cereal prototypes (low GL of 20 and 17, respectively) in reducing postprandial both glucose and insulin responses relative to the standard product (high GL of 26).

Relative to the standard product, IAUCs of 2-hour glucose and insulin were 15% and 22% lower in response to Prototype 1 and 25% and 35% lower in response to Prototype 2, respectively (p<0.05 in all cases).

Claims (37)

1. Complementary nutritional composition having a low glycemic load for use in the treatment, prevention and/or reduction of the risk of developing a disorder associated with metabolic syndrome manifesting later in life, wherein the disorder is selected from the group consisting of diabetes mellitus, in particular type 2 diabetes mellitus, cardiovascular disease, impaired glucose tolerance, impaired fasting glucose levels, impaired glucose homeostasis, insulin resistance, wherein the composition is characterized by a low glycemic index and/or contains an ingredient that is characterized by a low glycemic index, and low glycemic load means a glycemic load equal to or less than 20, and low glycemic index means a glycemic index equal to or less than 70, moreover, in later life refers to the period of time after childhood, that is, after the age of 12 years, which contains at least one low glycemic index carbohydrate ingredient selected from the group consisting of: resistant starches, lactose, isomaltulose, galactose and fructose, wherein the composition is administered to an infant or young child who is at risk of developing a disorder associated with metabolic syndrome, and while the composition contains the amount of added sugars with a low glycemic index, which varies in the range from 1 to 30 wt.%. 2. Complementary nutritional composition for use according to claim 1, which contains an amount of added sugars with a low glycemic index, which varies in the range from 1 to 20 wt.%. 3. Complementary nutritional composition for use according to claim 1 or 2, which contains added fiber species in an amount ranging from 1 to 8% by weight. 4. Complementary nutritional composition for use according to any one of the preceding claims, which contains cereal flour in an amount ranging from 20 to 90% by weight. 5. Complementary nutritional composition for use according to any of the preceding claims, which contains sugars in an amount ranging from 5 to 18% by weight. 6. Complementary nutritional composition for use according to any one of the preceding claims, which contains dietary fiber species in an amount ranging from 1 to 25% by weight. 7. Complementary nutritional composition for use according to any one of the preceding claims, which is administered to an infant or young child whose age is from 4 months to 5 years, for example from 6 months to 3 years. 8. Complementary nutritional composition for use according to any one of the preceding claims, which is administered in the context of a low glycemic load and/or low glycemic index diet to an infant or young child whose age is from 6 months to 5 years, preferably from 6 months to 2 years old 9. Complementary nutritional composition for use according to any of the preceding claims, which is an infant cereal, formula for feeding children or milk formula for children from 1 to 3 years, a puree or biscuit adapted for infants or young children, and preferably the composition is an infant cereal product. 10. Complementary nutritional composition characterized by a low glycemic load, for use in the treatment, prevention and/or reduction of the risk of developing a disorder associated with metabolic syndrome, manifested in later life, containing: - flour from cereals in an amount varying in the range from 20 to 90 wt.%; - sugar in an amount ranging from 5 to 30 wt.%, for example from 5 to 20 wt.%, for example from 5 to 18 wt.%; - added sugar with a low glycemic index in an amount varying in the range from 1 to 30 wt.%, for example from 1 to 20 wt.%, for example from 5 to 15 wt.%; - the total amount of dietary fiber in an amount ranging from 2 to 25 wt.%, preferably from 6 to 10 wt.%; - added fiber in an amount ranging from 0 to 20 wt.%, preferably from 1.5 to 7 wt.%; - legume in an amount ranging from 0 to 40%, preferably from 5 to 40 wt.%; - the fruit of the plant in an amount ranging from 0 to 25 wt.%, for example from 1 to 18 wt.%, and low glycemic load means a glycemic load equal to or less than 20, and low glycemic index means a glycemic index equal to or less than 70, moreover, in later life refers to the period of time after childhood, that is, after the age of 12 years, wherein the composition is administered to an infant or young child who is at risk of developing a disorder associated with metabolic syndrome. 11. Nutritional composition for complementary foods for use according to claim 10, containing: - flour from cereals in an amount varying in the range from 20 to 70 wt.%, for example from 30 to 55 wt.%, preferably from 33 to 50 wt.%; - fat in an amount ranging from 8 to 20 wt.% of the composition, preferably from 10 to 17 wt.%; - the total amount of dietary fiber in an amount ranging from 2 to 12 wt.%, preferably from 6 to 10 wt.%; - added fiber in an amount ranging from 0 to 10 wt.%, for example from 1 to 8 wt.%, for example from 1.5 to 7 wt.%; a dairy ingredient in an amount ranging from 0 to 35% by weight, preferably from 5 to 25% by weight; - legume in an amount ranging from 5 to 40 wt.%, for example from 8 to 30 wt.%. 12. The use of nutritional compositions for complementary foods according to any one of paragraphs. 1-11 for treating, preventing and/or reducing the risk of developing a disorder associated with metabolic syndrome manifesting later in life, wherein the composition is administered to an infant or young child who is at risk of developing a disorder associated with metabolic syndrome.

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