CN113662196A

CN113662196A - A nutritional composition for improving intestinal health

Info

Publication number: CN113662196A
Application number: CN202010420071.2A
Authority: CN
Inventors: 陈勇; 王炬; 潘健存
Original assignee: Heilongjiang Feihe Dairy Co Ltd
Current assignee: Heilongjiang Feihe Dairy Co Ltd
Priority date: 2020-05-13
Filing date: 2020-05-18
Publication date: 2021-11-19

Abstract

The invention relates to an infant nutritional composition, in particular to a nutritional composition and an infant formula food capable of improving infant intestinal health and/or improving infant intestinal tolerance and/or reducing infant eczema. Infant nutritional compositions include galactooligosaccharides, 1, 3-dioleoyl-2-palmitoyl triglyceride, hydrolyzed whey protein, and other nutritional ingredients.

Description

A nutritional composition for improving intestinal health

Technical Field

The invention relates to an infant nutritional composition, in particular to a nutritional composition capable of improving infant intestinal health and/or improving infant intestinal tolerance and/or reducing infant eczema, an infant formula food and a preparation method thereof.

Background

The breast milk is a natural food most suitable for infants, and is an ideal natural nutrient source for the infants. Breast milk can provide all nutrient components required for growth and development of infants, is the best choice suitable for absorption, gastrointestinal tract function and osmotic pressure of infants, and is also the key for promoting short-term and long-term health guarantee of infants. This is because the breast milk contains not only various nutrients which are necessary for the growth and development of the infant and have a suitable ratio and are easily digested and absorbed, but also active ingredients which have physiological functions of preventing infection, promoting the proliferation of intestinal cells and the like, and can help the infant to resist diseases. The infant stage is the fastest growing stage in the life of a human, sufficient energy, particularly the supply of high energy density fat, is necessary for the growth and development of the infant, and it is known that the milk of a well-nourished lactating mother can meet the nutritional requirements of the infant of 0-6 months of age.

At present, due to various factors such as working reasons or illness occurring in the lactation period, the infant mothers cannot carry out breast feeding on the infants, so that the breast feeding rate of the infants tends to be reduced, and for infants lacking breast milk and without breast milk, the breast milk is required to be designed as a 'gold standard' so as to obtain a formula which is most suitable for and meets the nutritional requirements of the infants, and the formula is used as a breast milk substitute. The original infant formula milk powder in the market mostly takes cow milk as a main raw material, but researches show that the fat and protein composition in cow milk are obviously different from that of breast milk.

In order to make infant formula milk powder closer to breast milk, scientists continuously research the nutrition of breast milk at present, and by adding the types of nutrients contained in the breast milk, the types of the nutrients such as protein, fat, carbohydrate, mineral matters, vitamins and the like are made to be as close to the breast milk as possible.

The establishment of a balanced intestinal microbiota during infancy is particularly important, whereas the intestinal microbiota of infants is rapidly established in the first few weeks after birth, and how to rapidly establish a balanced intestinal microbiota during infancy is a subject of intense research. Recently, it has been found that the presence of prebiotics, such as galactooligosaccharides, in breast milk affects and promotes the proliferation of specific microbial flora, such as bifidobacteria in the intestinal tract of infants.

The intestinal ecosystem is associated with the daily dietary components and the interaction among the various microflora in the intestinal ecosystem is very complex. Thus, when such ingredients are provided as a supplement in the diet of formula-fed infants, the base of the infant formula or other pediatric nutritional composition may then affect the effectiveness of the prebiotic, galactooligosaccharide. In addition, the type and concentration of lipids and proteins used in the formulation matrix may also modulate the intestinal microflora.

However, in many cases it has been found that infants fed by breast milk and infant formula also possess different gut microflora when actually fed. It is known that the intestinal microbiota of infants has a great influence on the immune system of infants, and that the regulation of the intestinal microbiota during infancy has a major impact on the future health status of infants. Similarly, the health of the gut is also an indicator of the health of infants, and infants with diarrhea, inadequate nutrient absorption, colic, altered sleep and altered growth, in addition to being associated with protein and fat digestion, are likely to be caused by altered intestinal microbiota.

In view of the above, the present invention is particularly proposed.

Disclosure of Invention

It is an object of the present invention to provide a nutritional composition comprising galacto-oligosaccharides, hydrolysed whey protein, 1, 3-dioleate 2-palmitoyl triglyceride and other nutritional ingredients for improving gut health and/or improving gut tolerance and/or reducing the incidence of eczema in infants.

It is a further object of the present invention to provide an infant nutritional composition further comprising alpha-lactalbumin, based on the above ingredients.

It is a further object of the invention to provide an infant nutritional composition, the protein source of which provides between 0.40g/100kJ and 1.2g/100kJ of protein, the total fat content is between 0.80g/100kJ and 1.43g/100kJ, and the carbohydrate content is between 1.8g/100kJ and 4g/100 kJ.

The inventor of the invention discovers that the components of the nutritional composition are close to breast milk through the effective combination of galacto-oligosaccharide, 1, 3-dioleate-2-palmitic acid triglyceride, hydrolyzed whey protein and other nutritional components, and the nutritional composition achieves better technical effects in the aspects of improving the intestinal health of infants and/or improving the intestinal tolerance of infants and/or reducing the occurrence of infantile eczema.

Detailed Description

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art, but in case of conflict, the definitions in this specification shall control.

As used herein, the following terms have the following meanings.

The term "infant" refers to a person of 0-6 months of age.

The term "older baby" refers to a person 7-12 months of age.

The term "young child" refers to a person 13-36 months of age.

The term "infant" broadly refers to a person 0-36 months of age.

The expression "nutritional composition" refers to a composition that provides nutrients to a subject, nutritionally feeding the subject. Typically, the nutritional compositions are ingested parenterally, orally, parenterally or intravenously, and typically comprise a lipid or fat source and a protein source. Preferably, the nutritional composition is for oral use.

In the context of the present invention, the nutritional composition is typically a synthetic nutritional composition, i.e. a composition not derived from a human (e.g. the composition is not breast milk). Some embodiments of the nutritional composition according to the invention are infant formulas, infant supplementary foods, nutritional supplements, reconstituted milk powders. The nutritional composition according to the invention is preferably an infant formula. The nutritional composition may be in powder or liquid form.

As used herein, the term "infant formula" refers to a nutritional composition for infants, as defined in the national standard of the people's republic of china "national standard for food safety infant formula" (GB10765), food Codex STAN 721981), and is infant specific. As defined in national Standard for food safety infant formula (GB10765) of the people's republic of China, it refers to a liquid or powder product prepared by adding appropriate amount of vitamins, minerals and/or other ingredients into main raw materials (milk and milk protein products or soybean and soybean protein products) and only using physical method. Is suitable for normal infants, and the energy and nutrient components of the infant formula can meet the normal nutritional requirements of the infants of 0-6 months. It also refers to a food product that is specifically designed to provide nutrition to infants in the first months of life, and which itself meets the various nutritional requirements of such infants (subject to article 2(C) of the No. 91/321/EEC 2006/141/EC directive for infant and follow-up infant formulas issued by the european union council 2006 at 12/22), as defined by the food code (Codex STAN 721981).

The infant formula may include infant formulas, follow-on formulas and infant formulas. Typically, infant formulas are used as breast milk substitutes from the birth of the infant, older infant formulas are used as breast milk substitutes from 7-12 months after the birth of the infant, and toddler formulas are used as breast milk substitutes from 13-36 infants.

The term "infant formula" refers to a liquid or powder product made by adding appropriate amounts of vitamins, minerals and/or other ingredients to milk and milk protein products or soy and soy protein products as the main raw materials and producing and processing only by physical methods. Is suitable for normal infants, and the energy and nutrient components of the infant formula can meet the normal nutritional requirements of the infants of 0-6 months.

The term "follow-up infant formula" refers to a liquid or powder product made by adding appropriate amounts of vitamins, minerals and/or other ingredients to milk and milk protein products or soy and soy protein products as the main raw materials and producing and processing by physical methods only. Is suitable for older infants, and has energy and nutritional components capable of meeting partial nutritional requirements of older infants of 7-12 months.

The term "infant formula" refers to a liquid or powder product prepared by using milk and milk protein products or soybean and soybean protein products as main raw materials, adding appropriate amount of vitamins, minerals and/or other components, and producing and processing by a physical method. Is suitable for children, and has energy and nutritional components capable of meeting partial nutritional requirements of normal children of 13-36 months.

"mother's milk" is understood to mean mother's milk or colostrum.

The term "sn-2 palmitic acid" as used herein refers to palmitic acid bonded at the sn-2 position of a triglyceride.

"high sn-2 palmitic acid triglycerides" refers to triglycerides with more than 45% palmitic acid bonded at the sn-2 position.

Fully breastfed infants or young children: has the usual meaning of referring to infants whose vast majority of nutrients and/or energy are derived from human breast milk.

Infants/older infants/young children, fed predominantly with infant formula, have the usual meaning: the nutrient source of nutrient substances and/or energy mainly comes from infant formula food, larger infant milk or infant growing up milk which are produced and processed by a physical method. By "primarily" is meant at least 50% of those nutrients and/or energies, or at least 75%.

All percentages are by weight unless otherwise indicated.

The invention will now be described in more detail. It should be noted that the various aspects, features, examples, and embodiments described herein may be compatible and/or may be combined together.

Furthermore, in the context of the present invention, the term "comprising" or "comprises" does not exclude other possible elements. The compositions of the present invention (including the various embodiments described herein) may comprise, consist of, or consist essentially of the following elements: essential elements and necessary limitations of the invention described herein, as well as any other or optional ingredients, components or limitations described herein or otherwise required.

The term "hydrolysis" means in the context of the present invention that a protein has been wholly or partially hydrolyzed into small molecules, peptides or free amino acids thereof.

Prebiotics

Prebiotics are non-digestible food ingredients that beneficially affect the host by selectively stimulating the growth and/or activity of one or a limited number of bacteria in the colon, thereby improving host health. These ingredients are indigestible in the sense that they are not broken down and absorbed in the stomach or small intestine, so that they pass intact through the stomach and small intestine to the colon where they are selectively fermented by beneficial bacteria.

Galacto-oligosaccharides

Galactooligosaccharides are oligosaccharides comprising two or more galactose molecules, which are not charged, nor have N-acetyl residues.

The expressions "galacto-oligosaccharide" and "GOS" may be used interchangeably. They refer to oligosaccharides comprising two or more galactose molecules, which are not charged, nor have N-acetyl residues.

The nutritional composition of the invention is preferably used in infant formulas such as infant formulas and/or follow-on formulas and/or toddler formulas. The infant or young child may be between 0 and 36 months of age, preferably between 0 and 12 months of age, more preferably between 0 and 6 months of age.

The invention provides a nutritional composition for improving infant intestinal health and/or infant intestinal tolerance and/or reducing eczema, which comprises galacto-oligosaccharide, hydrolyzed whey protein, 1, 3-dioleate 2-palmitic acid triglyceride and other nutritional ingredients. Wherein the other ingredients include, but are not limited to, raw milk, desalted whey liquid or desalted whey powder, docosahexaenoic acid, arachidonic acid, and the like.

The raw milk source can be selected from cow milk. "cow milk" or "cow milk" are used interchangeably herein, as known to those skilled in the art, and include, but are not limited to: plain milk, such as whole milk; liquid milk fractions obtained by processing normal milk, such as semi-skimmed milk obtained by skimmed milk, ultrafiltered milk, concentrated milk; or reconstituted milk formulated with one or more of milk powder, cream, hydrolyzed protein, whey powder, or other components of milk.

In the infant nutritional composition of the invention, the desalted whey may be derived from desalted whey, desalted whey powder, or a combination thereof.

Suitable galactooligosaccharides according to the present nutritional composition include Gal β 1,3Gal β 1,4Glc, Gal β 1,6Gal β 1,4Glc, Gal β 1,3Gal β 1,4Glc, Gal β 1,6Gal β 1,4Glc, Gal β 1,3Gal β 1,6Gal β 1,4Glc, Gal β 1,6Gal β 1,3Gal β 1,4Glc, Gal β 1,6Glc, Gal β 1,3Glc, Gal β 1,4Glc and Gal β 1,4Glc, and any mixture thereof. Synthetic galactooligosaccharides such as Gal β 1,6Gal β 1,4Glc, Gal β 1,6Glc, Gal β 1,3Gal β 1,4Glc, Gal β 1,6Gal β 1,4Glc, Gal β 1,6Gal β 1,3Gal β 1,4Glc, Gal β 1,3Gal β 1,6Gal β 1,4Glc, Gal β 1,4Glc, and Gal β 1,4Glc and mixtures thereof. Available under trade name and commercially. Other suppliers of galactooligosaccharides are Friesl and Campina Domo, Quantum Hitaceae (China Co., Ltd.), bowling Bao Bio Inc., and the like. Alternatively, specific glycosyltransferases (such as galactosyltransferases) may be used to produce neutral oligosaccharides.

In one aspect the invention relates to a nutritional composition comprising at least 1.5 wt.%, preferably at least 3 wt.% of galactooligosaccharides.

In some embodiments of the invention, such as in infant formulas, preferably from 2% to 15% galacto-oligosaccharide, more preferably from 2% to 10% galacto-oligosaccharide, on a dry basis.

The nutritional composition contains 1, 3-dioleoyl-2-palmitic acid triglyceride which is also called OPO structure fat, has a special two-position palmitic acid structure, and is not easy to form calcium soap during digestion, so that the nutritional composition is not easy to cause constipation of infants and is easier to absorb fatty acid and calcium.

In one aspect the invention relates to an infant nutritional composition comprising at least 2 wt.%, preferably at least 4 wt.% 1, 3-dioleate 2-palmitoyl triglyceride (calculated as C52). The sn-2 palmitic acid content is at least 45% of the palmitic acid content of the total fatty acids.

In some embodiments of the invention, such as infant formulas, the content of 1, 3-dioleoyl 2-palmitoyl triglyceride (as C52) is preferably between 2% and 15% by weight, more preferably between 3% and 10% by weight.

The 1, 3-dioleoyl 2-palmitoyl triglyceride may be derived from any source that provides nutrition to infants. Some sources of 1, 3-dioleate-containing 2-palmitic acid triglycerides include, for example, bovine milk, goat milk, vegetable oils, and the like.

The protein can meet the amino acids required by infants and young children in growth and development, the appropriate protein quality and the essential amino acid content ensure the satisfactory growth of the infants and young children, and the protein content and the type close to the breast milk are considered to be the most critical to the invention. A particular protein may provide the most suitable substrate for the microbiota.

The hydrolyzed whey protein of the present invention is a partially hydrolyzed whey protein which has been partially hydrolyzed into small molecule proteins, peptide fragments or free amino acids thereof.

In one embodiment, the hydrolyzed whey protein is available from denmark ARLA.

Alpha-lactalbumin

The "alpha-lactalbumin" of the present invention is the major protein present in breast milk. The structure of alpha-lactalbumin consists of 123 amino acids and 4 disulfide bonds.

The alpha-lactalbumin can be derived from raw cow and/or sheep milk, whole milk powder, skimmed milk powder, desalted whey liquid, lactalbumin powder (alpha-lactalbumin powder), milk fat globule membrane protein, and concentrated lactalbumin powder.

The hydrolyzed whey protein of the invention is present in an amount and/or amount of at least 0.3 wt.%, preferably in an amount sufficient to have the effect of promoting gut health and/or improving gut tolerance and/or reducing the incidence of eczema in infants and/or young children with galacto-oligosaccharides, 2-palmitoleic acid triglycerides in the composition.

In some embodiments of the invention, such as in infant formulas, the preferred amount of hydrolyzed whey protein is sufficient to have the effect of promoting gut health and/or improving gut tolerance and/or reducing the incidence of eczema in infants with galacto-oligosaccharides, 1, 3-dioleate 2-palmitate triglycerides in the composition. Preferred compositions comprise hydrolysed whey protein in an amount and/or addition of 0.55-6.00%.

In particular, the composition may further comprise 0.50 wt% to 3.00 wt% of alpha-lactalbumin.

It is believed that the presence of certain amounts of hydrolyzed whey protein and alpha-lactalbumin may be more favorable for digestive absorption.

The nutritional composition of the invention comprises in addition to hydrolyzed whey protein and alpha-lactalbumin, a source of other proteins. The other protein source is preferably selected from raw cow and/or sheep milk, whole milk powder, skimmed milk powder, desalted whey liquid, whey protein powder (alpha-lactalbumin powder), concentrated whey protein powder, milk fat globule membrane protein and their combination.

The protein source of the invention can provide between 0.40g/100kJ to 1.2g/100kJ of protein.

As far as whey proteins are concerned, the protein source may preferably be bovine and/or ovine milk, whole milk powder, skim milk powder, desalted whey, whey protein powder (alpha-lactalbumin powder), concentrated whey protein powder, hydrolyzed whey protein powder, milk fat globule membrane protein and combinations and mixtures thereof.

The infant nutritional compositions of the present invention may also comprise a source of carbohydrates. The composition may comprise one or more carbohydrates. The preferred carbohydrate source is lactose, but other carbohydrates may be added. Preferably, the carbohydrate present in the nutritional composition according to the invention is between 1.8g/100kJ and 4g/100 kJ.

The infant nutritional composition of the invention comprises, in addition to the 1, 3-dioleoyl 2-palmitoyl triglyceride, a source of other fats. The fat source may be any lipid or fat or lipid or fat containing material suitable for feeding a nutritional composition to an infant. Preferred fat sources include bovine and/or ovine milk, soybean oil, and/or coconut oil, and/or linseed oil, and/or walnut oil, and/or soybean lecithin, and/or sunflower seed oil, and/or phospholipids. The essential polyunsaturated fatty acids linoleic and alpha-linolenic acid, as well as the long chain polyunsaturated fatty acids arachidonic acid (ARA) and docosahexaenoic acid (DHA) may also be added. The total fat content of the infant formula of the invention may be between 0.8g/100kJ and 1.43g/100 kJ. Preferably, the ratio of linoleic acid to alpha-linoleic acid in the fat source is between 5:1 and 15:1, preferably 8:1 to 11:1, even more preferably 10:1, and the ratio of arachidonic acid and docosahexaenoic acid in the fat source is preferably between 4:1 and 1:1, preferably between 1:1 and 2: 1.

The nutritional composition may also comprise all vitamins and minerals that are considered essential for the daily diet, in particular to maintain the normal nutritional needs of the infant, which are present in the composition as nutrients. Minimum requirements for certain vitamins and minerals have been identified. Examples of minerals, vitamins, and other nutrients optionally present in the nutritional composition include vitamin a, vitamin D, vitamin E, vitamin K, vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin C, biotin, folic acid, inositol, niacin, pantothenic acid, choline, calcium, phosphorus, iodine, iron, magnesium, copper, zinc, manganese, chlorine, potassium, sodium, selenium, taurine, and l-carnitine. The minerals are usually added in the form of salts.

Other Components

If necessary, the nutritional composition may comprise emulsifiers and stabilizers, for example: phospholipids, and the like.

The infant formula containing the nutritional composition according to the invention may optionally comprise compounds which may also have beneficial effects or other ingredients well known in the art, such as lutein, nucleotides, casein phosphopeptides. The amounts are those amounts normally used in nutritional compositions.

Casein phosphopeptides (CPP for short) are polypeptides with biological activity prepared by using cow milk casein as a raw material and adopting a biological technology. Has good stability. In human body, calcium is easy to be absorbed only when existing in ion form, and calcium is easy to form insoluble salt with acid radical ions in neutral and weak alkaline environment and then lose. CPP can be combined with calcium, so that loss of calcium due to generation of insoluble precipitates is avoided, and finally calcium is passively diffused and absorbed in intestinal tracts due to increase of the concentration of free calcium, so that the effect of osteoclast is weakened, and bone resorption is inhibited.

The infant formula containing the nutritional composition according to the present invention may use nucleotides, which may consist of cytidine 5' -monophosphate (CMP) and/or its sodium salt, uridine 5' -monophosphate (UMP) and/or its sodium salt, adenosine 5' -monophosphate (AMP) and/or its sodium salt, guanosine 5' -monophosphate (GMP) and/or its sodium salt, inosine 5' -monophosphate (IMP) and/or its sodium salt and mixtures thereof.

All of the ingredients of the present invention are commercially available.

The present infant nutritional composition contains galactooligosaccharides in an amount of at least 1.5 wt.%, preferably at least 3 wt.%. Preferably from 2% to 15% by weight, more preferably from 2% to 10% by weight.

The content of 1, 3-dioleoyl-2-palmitoyl triglyceride in the infant nutritional composition of the invention is at least 2 wt.%, preferably at least 4 wt.%, more preferably from 2 wt.% to 15 wt.%, even more preferably from 3 wt.% to 10 wt.%.

The infant nutritional composition of the invention comprises at least 0.3 wt.% of hydrolysed whey protein, preferably alpha-lactalbumin in an amount of 0.50 wt.% to 3.00 wt.%.

In addition, all the ingredients of the invention can be obtained by the market and meet the requirements of infant food.

The infant nutritional compositions of the present invention may be formed in any suitable manner for infant feeding, such as infant formulas, baby snacks, nutritional supplements, modified milk powders, formula milks, infant formulas, and the like.

Compared with the prior art, the invention has the beneficial effects that:

the infant nutritional composition has the effects of improving the intestinal absorption, intestinal tolerance and eczema occurrence of infants.

The infant nutritional composition provided by the invention has no obvious difference between the intestinal health condition of infants and breast-fed infants due to the components, and particularly has the aspects of defecation times, stool characters, stool color and the like.

The infant nutritional composition provided by the invention has good intestinal tolerance. Experiments show that after the nutritional composition disclosed by the invention is eaten, the average daily crying frequency, crying time, milk overflow frequency and the like of the infants can be obviously reduced.

The infant nutritional composition provided by the invention can improve the intestinal flora formation of infants, and has no obvious difference with a breast feeding group.

The short-chain fatty acid is a main product of colon fermentation of a human body, has important effects on the human body, such as intestinal flora regulation, energy supply, body fluid and electrolyte balance maintenance and the like, and has the excrement short-chain fatty acid content close to that of infants and breast milk group infants eating the infant formula milk powder containing the nutritional composition.

Infants fed infant formula comprising the nutritional composition of the invention have a higher intestinal immunity than children fed regular milk powder. In addition, the infant nutritional composition can reduce the occurrence of infantile eczema.

Embodiments of the present invention will be described in detail below with reference to examples, but it will be understood by those skilled in the art that the following examples are only illustrative of the present invention and should not be construed as limiting the scope of the present invention. The examples, in which specific conditions are not specified, were conducted under conventional conditions or conditions recommended by the manufacturer. The reagents or instruments used are not indicated by the manufacturer, and are all conventional products available commercially.

Example 1

This example provides a formula milk powder for infants, which comprises (unit: kg)

The preparation method is the conventional method in the field.

Example 2

The preparation method is the conventional method in the field.

Example 3:

this example provides a control group of milk powder for experiments, which has the following formulation (unit: kg).

The preparation method is the conventional method in the field.

Test examples

The double-blind and random grouping test performed in Jinhua, Zhejiang, China tests the improvement effect of the control group, breast milk and the test group (namely the nutritional composition provided by the invention) on the intestinal absorption and intestinal tolerance of infants and the occurrence condition of eczema.

180 infants born 7-90 days need to be recruited in the study, and are randomly allocated into 3 groups, 60 breast milk groups, 60 control groups and 60 test product groups, so that at least 144 infants are finally guaranteed to complete the study.

The study adopts double-blind, random grouping, breast milk-study control group, single center and three groups of clinical studies. Study was expected to last for 12 weeks.

The three groups of infants respectively took the following products: group 1 (control, fed the product of example 3); group 2 (test group, fed the product of example 1); group 3 (breast milk feeding group).

The test totally has 180 infants entering the group, 4 infants exit in the test process, wherein 1 in the group 1, 1 in the group 2, 2 in the breast milk group, and the reason for exiting the group is not found to be related to the product, and 176 infants finally finish the test and are brought into statistical analysis.

Test example 1

Study on the Effect on intestinal health

The test was conducted to observe the number of bowel movements, stool characteristics and stool color in infants on 5 days per week in weeks 4, 8 and 12 and to determine whether the infants fed infant formula had a difference in bowel health from breast milk.

Defecation frequency, stool character and stool color

The baseline average daily stool frequency, stool character score and stool color score of each test group were not significantly different (table 3), and as the infant age in the month increased, the weekly average daily stool frequency of each group of infants during the test period gradually decreased, the stool character score gradually decreased, and the stool color score increased. The average number of bowel movements per day and the amplitude of change in stool color scores were greater for group 2 and breast milk than for group 1, with the differences increasing progressively; while the decrease in fecal trait score was greatest in group 1 and least in the breast milk group in group 2.

Statistical differences were observed between the group comparisons of the daily stool frequency and stool characteristics score from week 4 of the study (p <0.001, multiple comparisons show that group 1 had an average daily stool frequency and stool characteristics score significantly lower than the breast milk group, stool color score also appeared between the groups at week 8, group 1 had a score significantly lower than the breast milk group, group 2 had no statistical differences between the stool indices and the breast milk group, the results are shown in table 1.

TABLE 1 duration of the test period infant defecation in each test group (mean. + -. standard deviation, single factor analysis of variance)

P < 0.05; p < 0.001; no mark, p is more than or equal to 0.05

Wherein, the test on the defecation times shows that:

at the start of the experiment, there were no differences between the three groups, with group 1 having a clear difference from the breast milk group at week 4, and by week 12, group 2 was closer to the breast milk group, while group 1 was significantly different from the other two groups.

The test result shows that the infant eating the nutritional composition can increase the defecation times of the infant, and the times are close to those of a breast milk group after 3 months. While the control group had less number of stools per day.

For stool traits, stool color, significant differences in stool trait scores occurred between group 2 and group 1 starting at week 4; at week 12, group 2 feces color was significantly different from group 1, but not statistically different from the breast milk group.

The stool character score includes soft, hard, character and other factors, the stool score of the infants eating the breast milk is higher, the stool score of the infants eating the milk powder of the control group is lower, and the stool score of the infant formula milk powder group eating the nutritional composition is closer to that of the breast milk group without difference. The color score of the feces of the common milk powder is very different from that of the breast milk.

Test example 2

Study on intestinal tolerance of infants

The tests were carried out to evaluate the intestinal tolerance of infants 5 days after each week, on weeks 4, 8 and 12, by observing the average number of crying per day, the cumulative crying time per day and the number of milk spills.

Number and time of crying

Table 2 shows the mean and standard deviation of the average daily crying times and the cumulative daily crying times for each group of infants, and the comparison of the differences between groups. At baseline, there was no significant difference between the average daily crying times and the cumulative daily crying times for each group; as the experiment proceeded, the number of crying times and the cumulative crying time of the group 2 and breast milk group gradually decreased, the number of crying times and the cumulative crying time of the group 1 increased at week 4, then decreased slightly, but always higher than those of the other two groups; from the 4 th week to the end of the experiment, the number of crying times per day and the time of the test were significantly different between the groups, and multiple comparisons showed that the number of crying times per day and the time of the test were significantly higher in group 1 than in the breast milk group, and no significant difference was observed between group 2 and the breast milk group.

TABLE 2 Cry condition of the infants in each test group during the test period

Mean ± standard deviation, single factor analysis of variance (p value)

P < 0.05; p < 0.01; no mark, p is more than or equal to 0.05

During the whole experiment, the crying times of the infants of the group 2 and the breast milk group are not different, while the differences of the group 1 and the other two groups are obvious; the crying time is similar to the crying times;

the factors influencing the crying of the infants are many, the body comfort is an important influence factor, and compared with a control group, the infant formula milk powder containing the nutritional composition can obviously improve the body comfort of the infants, reduce the crying times of the infants and reduce the crying time of each time.

Number of milk spills

Table 3 shows the mean and standard deviation of the mean daily number of milk spills per week for each group of infants, and the comparison of the differences between groups. At baseline, the milk spilling times of all groups have no obvious difference, except that the average daily milk spilling times of the group 1 at week 4 are increased, and the milk spilling times of all groups of infants are gradually reduced along with the increase of the month ages of the infants; the comparisons between groups showed significant differences starting at week 4 of the experiment, with the average daily number of milk spills in the breast milk group being significantly lower than in group 1, and not significantly different from group 2.

TABLE 3 milk loss in the test groups during the test period

Mean ± standard deviation, single factor analysis of variance (p value)

TABLE 3 milk loss in the test groups during the test period

Mean ± standard deviation, single factor analysis of variance (p value)

*:p<0.05；**:p<0.01；no symbol:p≥0.05

Starting at week 4, the number of milkings in group 1 differed significantly from that in the breast milk group and group 2, while there was no difference between group 2 and the breast milk group. It can be seen that the infant formula comprising the nutritional composition according to the invention significantly reduces the number of milk spills, more closely resembling that of breast milk.

Test example 3

Influence on intestinal flora of infants

Changes in the intestinal flora of the infants during the test are listed in table 4. At baseline and during experimental intervention, the contents of bifidobacterium, lactobacillus and clostridium perfringens in intestinal tracts of all groups of infants have no statistical difference. After 3 weeks of product intervention, the numbers of bifidobacteria and lactobacilli were slightly increased and the number of perfringens was slightly decreased in groups 2 and breast milk, but there was no significant difference from the start of the experiment; group 1 intestinal flora did not change significantly during the test.

TABLE 4 changes in the intestinal flora of infants in the test groups during the test period

Mean ± standard deviation, single factor analysis of variance (p value)

Test example 4

Influence on infant intestinal short-chain fatty acids

Changes in infant fecal short chain fatty acids during the trial are listed in table 5. The fecal short-chain fatty acid has no interclass difference at baseline, significant interclass difference (p values are 0.021 and 0.019 respectively) occurs in the fecal acetic acid content and the total short-chain fatty acid content after 3 weeks of intervention, and the difference between the two indexes before and after intervention is also significant interclass difference (p values are 0.003 and 0.001 respectively); the contents of propionic acid and butyric acid were not significantly different between groups before and after intervention.

TABLE 5 duration of the test period changes in short chain fatty acids in infant faeces (mean. + -. standard deviation, single factor analysis of variance)

P < 0.05; p < 0.01; p < 0.001; no mark, p is more than or equal to 0.05

After 3 weeks from the start of the experiment, there was no difference between the acetic acid and total short chain fatty acid content in the feces of the breast milk group and group 2. The short-chain fatty acid is a main product of colon fermentation of a human body, has important effects on the human body, such as intestinal flora regulation, energy supply, body fluid and electrolyte balance maintenance and the like, and has the excrement short-chain fatty acid content close to that of infants and breast milk group infants eating the infant formula milk powder containing the nutritional composition.

Test example 5

Effect on intestinal secretory immunoglobulin (sIgA)

Changes in fecal sIgA content during the trial are listed in Table 6. There was no difference between groups in fecal sIgA content at baseline, and there was a significant difference between groups 12 weeks after intervention (p 0.000), and there was also a significant difference between the pre-and post-intervention differences for both indices (p 0.022).

Table 6 units of change in fecal sIgA content of infants of each test group during the test: ug/ml

Mean ± standard deviation, single factor analysis of variance (p value)

P < 0.05; p < 0.01; no mark, p is more than or equal to 0.05

After 3 months of consumption of the milk powder, there was a significant difference in intestinal sIgA in infants between group 1 and the breast milk group, whereas infants consuming the infant formula comprising the nutritional composition according to the invention had no difference compared to the breast milk group.

Secretory sIgA is present in human body's secretory fluids and is a major antibody of body's mucosa for local immunity against infection, and from the above results, it can be presumed that infants who consume the infant formula containing the nutritional composition of the present invention have higher intestinal immunity than children who consume ordinary milk powder.

Test example 6

Influence on infantile eczema

Table 7 lists the past history of eczema in each group of infants, and chi-square test results showed no significant differences between groups in the presence of eczema before the start of the trial.

TABLE 7 incidence of eczema in the infants of the test groups during the test period

Number of people (percentage), chi fang test

The incidence and duration of eczema in the groups of infants during the trial are shown in table 8. A total of 32 (18.2%) infants developed eczema, with 15 in group 1 (25.4%), 9 in group 2 (15.3%), and 8 in the breast milk group (13.8%). The duration of eczema was the longest in group 1, and thereafter, the breast milk group was the lowest in group 2. There were significant differences between groups in both eczema incidence and duration.

TABLE 8 incidence of eczema in the infants of the test groups during the test period

Number of people (percent), chi-square test mean ± standard deviation, ANOVA

The results of pairwise comparisons of differences between groups (table 8) show that the duration of eczema was significantly higher in group 1 than in the breast milk group (p ═ 0.005); no significant difference in eczema duration was seen in group 2 compared to the breast milk group.

While particular embodiments of the present invention have been illustrated and described, it would be obvious that various other changes and modifications can be made without departing from the spirit and scope of the invention. It is therefore intended to cover in the appended claims all such changes and modifications that are within the scope of this invention.

Claims

1. A nutritional composition for infants, comprising galacto-oligosaccharides, 1, 3-dioleoyl-2-palmitoyl triglyceride, hydrolyzed whey protein and other nutritional ingredients.

2. The infant nutritional composition according to claim 1, characterized by further comprising alpha-lactalbumin.

3. Infant nutritional composition according to claim 1 or 2, characterized in that the nutritional composition comprises at least 1.5 wt.%, preferably at least 3 wt.% galactooligosaccharides.

4. Infant nutritional composition according to any one of claims 1 to 3, characterized in that the nutritional composition comprises at least 2 wt.%, preferably at least 4 wt.% of 1, 3-dioleoyl-2-palmitic acid triglyceride, more preferably 2 wt.% to 15 wt.%, even more preferably 3 wt.% to 10 wt.% of 1, 3-dioleoyl-2-palmitic acid triglyceride.

5. Infant nutritional composition according to any one of claims 1-4, characterized in that the nutritional composition comprises at least 0.3 wt.% of hydrolysed whey protein.

6. Infant nutritional composition according to claim 2, characterized in that the content of alpha-lactalbumin is between 0.50 and 3.00 wt%.

7. Infant nutritional composition according to any one of claims 1-6, characterized in that the protein source provides between 0.40g/100kJ and 1.2g/100kJ of protein, the total content of fat is between 0.80g/100kJ and 1.43g/100kJ and the carbohydrate is between 1.8g/100kJ and 4g/100 kJ.

8. Infant nutritional composition according to any one of claims 1-7, characterized in that the infant nutritional composition is in the form of an infant formula, an infant complementary food, a nutritional supplement, a recombined milk powder, a formula milk or an infant formula.

9. Use of an infant nutritional compound according to claims 1-8 for the manufacture of a nutritional composition, infant formula for improving infant gut health and/or improving infant gut tolerance and/or reducing the incidence of eczema in infants.