[go: up one dir, main page]

WO2024161209A1 - Procedure for creating a recipe for patients suffering from phenylketonuria - Google Patents

Procedure for creating a recipe for patients suffering from phenylketonuria Download PDF

Info

Publication number
WO2024161209A1
WO2024161209A1 PCT/IB2024/000012 IB2024000012W WO2024161209A1 WO 2024161209 A1 WO2024161209 A1 WO 2024161209A1 IB 2024000012 W IB2024000012 W IB 2024000012W WO 2024161209 A1 WO2024161209 A1 WO 2024161209A1
Authority
WO
WIPO (PCT)
Prior art keywords
fibre
starch
food
phenylketonuria
semi
Prior art date
Application number
PCT/IB2024/000012
Other languages
French (fr)
Inventor
Marco Alvise Formiconi
Giorgio Iacoponi
Original Assignee
Marco Alvise Formiconi
Giorgio Iacoponi
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from IT102023000001641A external-priority patent/IT202300001641A1/en
Application filed by Marco Alvise Formiconi, Giorgio Iacoponi filed Critical Marco Alvise Formiconi
Publication of WO2024161209A1 publication Critical patent/WO2024161209A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/17—Amino acids, peptides or proteins
    • A23L33/175—Amino acids
    • A—HUMAN NECESSITIES
    • A21—BAKING; EDIBLE DOUGHS
    • A21D—TREATMENT OF FLOUR OR DOUGH FOR BAKING, e.g. BY ADDITION OF MATERIALS; BAKING; BAKERY PRODUCTS
    • A21D13/00—Finished or partly finished bakery products
    • A21D13/06—Products with modified nutritive value, e.g. with modified starch content
    • A21D13/064—Products with modified nutritive value, e.g. with modified starch content with modified protein content
    • A21D13/066—Gluten-free products
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
    • A23L29/20—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents
    • A23L29/206—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents of vegetable origin
    • A23L29/212—Starch; Modified starch; Starch derivatives, e.g. esters or ethers
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/20—Reducing nutritive value; Dietetic products with reduced nutritive value
    • A23L33/21—Addition of substantially indigestible substances, e.g. dietary fibres
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/40—Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula

Definitions

  • This Invention relates to production processes for recipes created to address health symptoms and conditions resulting from various genetic mutations. More specifically, the field of application for this optimisation process concerns the condition known as Phenylketonuria or PKB, as stated in IT 102023000001641.
  • Phenylketonuria or PKB which is a metabolic defect with an autosomal recessive pattern of inheritance.
  • Phenylketonuria is caused by a mutation in the gene coding for phenylalanine hydroxylase (PAH), a liver enzyme that metabolises Phenylalanine (Phe) i.e. one of the essential amino acids found in most foods that contain protein.
  • PAH phenylalanine hydroxylase
  • Phe Phenylalanine
  • Phenylalanine leads to hyperphenylalaninemia in the blood (HPA), which causes serious issues in the body and the central nervous system especially, with considerable impact on the brain.
  • Phenylketonuria globally means it is classed as a rare disease, however it is estimated that, considering the entire range of variants, in Italy one newborn out of 2-3 thousand has this condition (source: Observatory of Rare Diseases, June 2019 - see NPL1 ). i [0008] The worldwide occurrence of this disorder is not consistent however, and studies are currently underway to investigate the cause of the different percentage incidence in relation to environmental and behavioural factors.
  • Phenylketonuria can cause the following issues if not treated correctly: i. autism spectrum disorder; ii. delayed cognitive development; iii. impaired growth; iv. epilepsy; v. motor deficits; vi. psychiatric symptoms; vii. cognitive disability.
  • the micro-encapsulation solution can overcome the unpleasant taste of a preparation when added to a beverage or solid food, but patient liking for substances that are specially created to ensure nutritional balance remains much lower than the average for that of other foods.
  • Application WO2018/014920 describes the formulation and method for producing a recombinant protein, which is created outside of its natural environment, and including it in a diet for people which has no Phenylalanine. Additionally, this protein can be absorbed as a high-grade protein. In this case too these special formulations and production methods are not integrated with the necessary solutions for these substances to produce foods with none of the issues stated in the previous sections, especially in relation to taste.
  • Application LIS2016184271 shows amino acid manipulation for managing neurogenetic conditions at a nutritional level, but it does not entirely relate to Phenylketonuria and the range of solutions that it is desirable to achieve when creating food, as stated in this patent application.
  • Phenylketonuria Diet Promotes Shifts in Firmicutes Populations; Frontiers in Cellular and Infection Microbiology - https://pubmed.ncbi.nlm.nih.gov/31058098/ - April 2019 - Giulia Bassanini, Camilla Ceccarani, Francesca Borgo, Marco Severgnini, Valentina Rovelli, Giulia Morace, Elvira Verduci, Elisa Borghi.
  • this study shows that in people affected by Phenylketonuria (or PKU) who are on a specific diet, a change in the gut microbiome can be detected.
  • the study was conducted with two groups each with twenty-one subjects between the ages of four and eighteen years old, amounting to a total of forty-two people.
  • a large amount of the bacteria Blautia and Clostridium was detected in subjects with hyperphenylalaninemia. Clostridium is known to cause diarrhoea, colitis and abdominal pain. A considerable reduction in the bacteria known as Faecalibacterium was also observed.
  • This recipe can be used to make sweet or savoury products, and can be adapted for use in a non-industrial environment, in a domestic setting for example.
  • the recipe is based on the use of RS4 modified starch of gluten-free wheat and a mix of ingredients which, with respect to the Prior Art, makes it possible to obtain: i. sweet and savoury foods devised for Phenylketonuria sufferers that taste better than similar products, thanks to the combined effect of the individual ingredients, as claimed, ii. sweet and savoury foods that do not change the gut microbiome as a result of long-term consumption, iii. sweet and savoury foods that enable the control of postprandial glycaemia.
  • the two recipe formulations have a significant element in common i.e. the presence of the entire amino acid spectrum made up of the proteins excluding Phenylalanine, because they are aimed at patients suffering from Phenylketonuria (or PKU), as stated in the previous sections.
  • the two recipe formulations have another element in common i.e. the presence of the RS4 modified starch of gluten-free wheat within the general category of carbohydrates - required for the body to produce energy via the Kreb's Cycle - at a percentage equal to or greater than 14% of the total amount of carbohydrates used.
  • the use of the modified starch is essential for mitigating postprandial glycaemia.
  • prebiotic fibre As per the priority claimed in IT 102023000001641 , the presence of a suitable amount of prebiotic fibre in the recipe formulation is aimed at controlling issues resulting from changes in the gut microbiome in patients suffering from Phenylketonuria (or PKU). This prebiotic fibre restricts the proliferation of bacteria that negatively affect function of the intestine and the immune system.
  • each of the two formulations is suitable for making dry foods or foods with RH between 5% and 30%.
  • the sweet and savoury products made using the recipe in IT 102023000001641 may have resistance to mechanical stress that is incompatible with industrial packaging and distribution processes in the food industry, especially when RH is very low or the products are classed as dry food.
  • Another area of optimisation in this patent application is a special recipe formulation for patients suffering from Phenylketonuria on the basis of age and gender.
  • the aim of this Invention is therefore to devise a process for making the recipe in IT 102023000001641 such that some aspects are enhanced further, in particular to make it less crumbly and more palatable.
  • the Invention describes an innovative process to optimise the production of the recipe claimed in IT 102023000001641 for creating specific foods for patients suffering from Phenylketonuria. These foods are highly appetising and appealing with a taste that is comparable to normal food produced in the retail food industry.
  • the Invention enables the production of food without the structural fragility that would prevent it from being packaged and transported in the food industry, and from being enjoyed by the patients consuming it.
  • the Invention also describes specific recipe formulations for patients suffering from Phenylketonuria on the basis of factors relating to age and lifestyle.
  • the foods produced as per the idea of the Invention are sufficiently robust such that they can be packaged and transported in the retail food industry; ii. the foods obtained as per the idea of the Invention do not break or crumble when consumed by patients; iii. the foods obtained as per the idea of the Invention comply with the nutritional requirements of patients suffering from Phenylketonuria and are crunchy; iv. thanks to the foods produced as a result of the Invention, patients suffering from Phenylketonuria (or PKU) will no longer have to consume supplements with an unpleasant taste, or augment a low-protein diet with the aforementioned supplements; v.
  • the foods produced as a result of the Invention cover the full range of sweet and savoury foods; vi. the taste of foods produced as per the idea of the Invention is comparable with foods already available in the normal food supply chain; vii. the foods produced as per the idea of the Invention effectively control patient microbiome; viii. the foods produced as per the idea of the Invention limit postprandial glycaemia; ix. the foods produced as per the idea of the Invention are suited to patients suffering from Phenylketonuria who need to manage their lean body mass.
  • the process in this Invention aims to create a nutritional precursor i.e. a semi-finished RS4 product obtained from the RS4 modified starch of gluten-free wheat already used in the recipe in IT 102023000001641.
  • This method of using the starch does not contribute to forming a nutritional mix that is structurally effective for creating foods in which, after the final cooking or drying phase, the characteristics of crunchiness or mechanical resistance are comparable with foods on the market not aimed at patients suffering from Phenylketonuria.
  • RS4 modified starch of gluten-free wheat is put into a mechanical mixer used to mix dough in the food industry.
  • the starch/H2O ratio may vary from a minimum of 0.5 to a maximum of 0.90.
  • the temperature of the water added to the RS4 modified starch of gluten-free wheat is 100°C, however water at a temperature in the range of 90°C to 100°C can be used.
  • the starch and water can now start to be mixed with the mechanical mixer.
  • the mixing process lasts for between 120 and 240 seconds, which is the time required for the RS4 modified starch of gluten- free wheat in contact with the water to acquire the physical/mechanical characteristics of the semi-finished RS4 product i.e. i. a solid form; ii. a non-sticky surface; iii. a compact, cohesive appearance, damp to touch but not wet; iv. malleable; v. a shape that doesn't tend to correspond to that of the container.
  • the semi-finished RS4 product acquires these physical characteristics thanks to the soluble fibres forming the RS4 modified starch of gluten-free wheat linking together. This process is facilitated by the mechanical action of the mixer and the temperature of the water with which it is mixed, lengthening the insoluble fibres to encourage them to link and intertwine.
  • the insoluble fibres create a three- dimensional structure which traps most of the water, thereby facilitating the creation of well-defined physical characteristics in the semi-finished RS4 product as described in section 0060.
  • a fluctuation in physical environmental parameters may affect the timescales for making the semi-finished RS4 product specified in section 0060.
  • the process can also be deemed as finished when the semi-finished RS4 product acquires the physical/mechanical characteristics specified in 0060 even if not within the timescales indicated.
  • the RS4 modified starch of gluten-free wheat and water can be mixed together in a sealed container with an internal air pressure greater than atmospheric pressure, to accelerate the processing time.
  • the semi-finished RS4 product can also reduce the sensation on the palate linked to the unpleasant odour typical of the RS4 modified starch of gluten-free wheat.
  • the semi-finished RS4 product can now be removed from the mechanical mixer and used to make the recipes in IT 102023000001641.
  • the linking between the soluble fibres will enable the nutritional preparations to withstand mechanical stress in the final cooking phase, and to retain the physical characteristics that prevent crumbling: i. when further processed to add ingredients (decoration, dusting, icing etc.) using manual or mechanical procedures; ii. when packaged for distribution in the food sector; iii. when consumed by patients suffering from Phenylketonuria.
  • the use of the semi-finished RS4 product also offers clear benefits when producing soft sweet and savoury goods, such as pies, muffins etc., or those with a high RH level.
  • the insoluble fibre arrangement in the semi-finished RS4 product resulting from the procedure, and described in the previous sections, enables the food mixture to be cohesive even when the relative humidity is much higher than goods defined as dry products. After cooking the recipes created as specified in IT 102023000001641 , this characteristic also prevents food with a high RH level from crumbling undesirably when consumed by patients.
  • the resistance to mechanical stress obtained by the food by using the semi-finished RS4 product to stop it from crumbling also gives it a bite and makes it crunchy.
  • This feature is highly desirable in food as it results in a more pleasurable eating experience.
  • soft fillings can be contrasted with the increased crunchiness of surrounding pastry, avoiding the cloying sensation perceived with the soft part of filled items.
  • the aim of this patent is to create specific foods for patients suffering from Phenylketonuria that are as enjoyable and tasty as normal foods available in the retail food industry, and to avoid the need for supplements and/or foods that lack these pleasurable characteristics.
  • this additional process is defined as a consolidation period.
  • the consolidation period is after the food has been cooked in the oven and before it undergoes the final drying phase.
  • the food is kept in an atmosphere with a temperature of no greater than 24°C for between 4 and 24 hours. This process makes the mixture obtained with the semi-finished RS4 product more solid and robust.
  • the consolidation period also ensures that the subsequent drying phase does not cause crumbling or breakage, as such phenomena are already limited by the presence of the semi-finished RS4 product in the mixture.
  • the following amino acid amounts, excluding Phenylalanine, are used on the basis of 100 g of each of the two recipes, one for sweet and one for savoury goods, as stated in IT 102023000001641 : i. L-serine 900 mg ii. L-threonine 1200 mg iii. L-leucine 2900 mg iv. L-glycine 1250 mg v. L-alanine 900 mg vi. L-arginine 1100 mg vii. L-cystine 650 mg viii. L-glutamine 4600 mg ix. L-histidine 700 mg x. L-aspartic acid 1800 mg xi.
  • the recipe for making 100 g of savoury baked goods using the innovative process to create the semi-finished RS4 product is as follows: i. Amino acids - as specified in section 0055 ii. RS4 modified starch of gluten-free wheat in the form of the semi-finished RS4 product 6.00 g iii. Corn starch 12.90 g iv. Potato starch 14.00 g v. Guar gum 2.00 g vi. Tara gum 2.50 g vii. Bamboo fibre 2.00 g viii. FOS fibre 1.50 g ix. Psyllium fibre 0.60 g x. Acacia fibre 1.00 g xi. Arabinoxylan fibre 2.00 g xii. Bromelain 0.45 g xiii. Sunflower oil 18.00 g
  • the following alternative sources of fibre can be used in the formulation of the recipe for savoury baked goods: a) oat fibre b) citrus fibre c) cocoa fibre d) honey fibre e) hazelnut fibre f) additional sources of soluble and insoluble fibre.
  • the recipe for making 100 g of sweet baked goods is as follows: i. Amino acids - as specified in section 0055 ii. RS4 modified starch of gluten-free wheat in the form of the semi-finished RS4 product 6.00 g iii. Corn starch 9.00 g iv. Potato starch 9.00 g v. Guar gum 2.00 g vi. Tara gum 2.00 g vii. Bamboo fibre 1.50 g viii. FOS fibre 1.50 g ix. Psyllium fibre 0.60 g x. Acacia fibre 0.50 g xi. Arabinoxylan fibre 2.00 g xii. Erythritol 14.00 g xiii. Sunflower oil 17.80 g
  • the following alternative ingredients can be used in the formulation of the recipe for sweet baked goods: a) rice starch b) tapioca flour c) IMO d) polydextrose e) isomaltulose f) rice flour g) starches in general.
  • the following alternative sources of fibre can be used in the formulation of the recipe for sweet baked goods: a) oat fibre b) citrus fibre c) cocoa fibre d) honey fibre e) hazelnut fibre f) additional sources of soluble and insoluble fibre.
  • additional ingredients are present in the formulation of the recipe for sweet baked products: i. Extra virgin olive oil 10.00 g ii. Butter 9.00 g iii. Raising agents (diphosphates, sodium carbonate, ammonium bicarbonate) 1.00 g iv. Raising agents (Ammonia) 0.70 g v. Flavourings 1.00 g vi. Masking agent 2.00 g vii. Emulsifying agent (Soy lecithin) 0.60 g viii. Antioxidant (Alpha-tocopherol) 0.20 g ix. Bromelain 0.45 g x. Salt 0.2 g
  • the amino acid formulation specified in 0074 and 0081 can easily be adapted for patients requiring sports nutrition, or a diet to increase lean body mass, or patients suffering from age- related sarcopenia.
  • the amounts of amino acids that can be used in the recipes in this Invention to make sweet and savoury goods as part of a nutritional plan for patients participating in sport are as follows: i. L-serine 780 mg ii. L-threonine 1080 mg iii. L-leucine 4000 mg iv. L-glycine 1120 mg v. L-alanine 770 mg vi. L-arginine 980 mg vii. L-cystine 520 mg viii. L-glutamine 4500 mg ix. L-histidine 600 mg x. L-aspartic acid 1800 mg xi. L-proline 1590 mg xii. L-isoleucine 2000 mg xiii.
  • the amounts of amino acids that can be used in the recipes in this Invention to make sweet and savoury goods as part of a nutritional plan for patients suffering from age-related sarcopenia are as follows: i. L-serine 775 mg ii. L-threonine 1077 mg iii. L-leucine 4500 mg iv. L-glycine 1127 mg v. L-alanine 778 mg vi. L-arginine 978 mg vii. L-cystine 525 mg viii. L-glutamine 4500 mg ix. L-histidine 600 mg x. L-aspartic acid 1700 mg xi. L-proline 1700 mg xii.
  • the recipes described in this Invention are suitable for making foods such as: i. Biscuits ii. Muffins iii. Tarts iv. Snacks v. Bread vi. Pizza vii. Pasta viii. Crackers ix. Sweet and savoury pies x. Baked goods in general.
  • the sectors specified can use the recipes in this Invention to produce foods that are extremely appetising and tasty and meet the nutritional requirements of patients suffering from Phenylketonuria.
  • NPL1 https://www.osservatoriomalattierare.it/malattie-rare/fenilchetonuria- pku/14959-fenilchetonuria-la-malattia-metabolica-piu-diffusa-oggi-il-world-pku- day
  • NPL2 https://www.golike-shake-and-drink.com/
  • NPL3 https://www.nutricia.it/prodotti/hom-2-secunda/ [0098] NPL4: Phenylketonuria Diet Promotes Shifts in Firmicutes Populations;
  • NPL6 Strategies Used in Production of Phenylalanine-Free Foods for PKU Management by Nafiseh Soltanizadeh and Leila Mirmoghtadaie.

Landscapes

  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Food Science & Technology (AREA)
  • Nutrition Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Polymers & Plastics (AREA)
  • Mycology (AREA)
  • Pediatric Medicine (AREA)
  • Dispersion Chemistry (AREA)
  • Molecular Biology (AREA)
  • General Health & Medical Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)

Abstract

The Invention describes an innovative process to optimise the creation of the recipe claimed in IT 102023000001641, with the option of creating specific foods for patients suffering from Phenylketonuria that do not have a structural fragility that prevents them from being suitably packaged and transported in the food supply chain, and from offering a pleasurable eating experience for patients. The Invention also includes recipe formulations specifically for patients suffering from Phenylketonuria and age- related Sarcopenia, and situations in which an increase in lean body mass is required due to sports activities.

Description

Description
Title of Invention: Procedure for creating a recipe for patients suffering from Phenylketonuria
Field of the Invention
[0001 ] This Invention relates to production processes for recipes created to address health symptoms and conditions resulting from various genetic mutations. More specifically, the field of application for this optimisation process concerns the condition known as Phenylketonuria or PKB, as stated in IT 102023000001641.
Background to the Invention
[0002] Many disorders can be explained as a mutation in genes that contain one or more instructions required for the proper function of the body, changing how it handles a series of processes, such as metabolic functions.
[0003] Obviously when studying the aetiology of these disorders, the ideal solution of choice would be gene therapy, however this treatment is only available for a percentage of the sum total of the aforementioned conditions.
[0004] One of the conditions with an exhaustive set of symptoms over the long-term is Phenylketonuria or PKB, which is a metabolic defect with an autosomal recessive pattern of inheritance.
[0005] Phenylketonuria is caused by a mutation in the gene coding for phenylalanine hydroxylase (PAH), a liver enzyme that metabolises Phenylalanine (Phe) i.e. one of the essential amino acids found in most foods that contain protein.
[0006] An inability to metabolise Phenylalanine leads to hyperphenylalaninemia in the blood (HPA), which causes serious issues in the body and the central nervous system especially, with considerable impact on the brain.
[0007] The statistical incidence of Phenylketonuria globally means it is classed as a rare disease, however it is estimated that, considering the entire range of variants, in Italy one newborn out of 2-3 thousand has this condition (source: Observatory of Rare Diseases, June 2019 - see NPL1 ). i [0008] The worldwide occurrence of this disorder is not consistent however, and studies are currently underway to investigate the cause of the different percentage incidence in relation to environmental and behavioural factors.
[0009] Phenylketonuria can cause the following issues if not treated correctly: i. autism spectrum disorder; ii. delayed cognitive development; iii. impaired growth; iv. epilepsy; v. motor deficits; vi. psychiatric symptoms; vii. cognitive disability.
[0010] As stated in section 0003, the only solution to date for managing the condition and enabling sufferers to have as normal a life as possible, is to strictly limit the amount of protein, and hence Phenylalanine, consumed. However this solution has serious nutritional shortcomings, therefore patients must take protein supplements specially designed by food/pharmaceutical companies. There are currently two possible solutions i.e. i. follow a low-protein diet, ii. synthesise Phenylalanine-free foods.
[0011 ] Experimentation and testing is in progress for additional solutions resulting from enzyme replacement prophylactics and adjuvant treatment, with Tetrahydrobiopterin (BH4) for example. While these studies are extremely important in the search for a definitive treatment, they are not at an advanced stage and are far from offering patients a safe, reliable solution.
[0012] In the Prior Art the solution provided by supplements specifically for Phenylketonuria, combined with a low-protein diet, consists of nutrients that are added to liquids such as fruit juices, teas, water and beverages in general.
[0013] The technique of micro-encapsulation is used to mask the unpleasant taste of these supplements, whereby the preparations are covered with a coating that does not dissolve in the mouth and stops the sense of taste from perceiving the flavour. Substances are added to the supplement to produce a pleasant flavour, to achieve olfactory masking that is as agreeable as possible.
[0014] The micro-encapsulation solution can overcome the unpleasant taste of a preparation when added to a beverage or solid food, but patient liking for substances that are specially created to ensure nutritional balance remains much lower than the average for that of other foods.
[0015] Additional important factors emerge from careful analysis, which have not yet been considered by the food and pharmaceutical industries and which consign the aforementioned food supplements to being 'special' preparations, bearing no relation to the pleasant experience obtained by eating normal food as part of a balanced diet: i. the diet which needs to be followed offers no alternatives, ii. given that in most cases this condition is diagnosed in childhood, opposition transpires immediately from patients, whereby the practical aspect fails to be a valid excuse for a radical change in the choice of food to eat. iii. the normal difficulty for parents in managing the growth and development of their children is therefore exacerbated by Phenylketonuria, which affects an aspect that should provide pleasure and satisfaction i.e. food; iv. even if the beverages suitably adapted by adding the aforementioned supplements available in the Prior Art were extremely tasty, obviously a beverage is not a solid food, so the pleasure of chewing is lost completely. v. Requiring patients to follow a controlled drinking schedule, even if the drinks taste pleasant, could never replace the pleasure of chewing solid food, be it animal or plant-based, or the pleasure of eating freely.
[0016] Various examples of supplements in the Prior Art that are specially created and marketed for managing Phenylketonuria include: i. https://www.golike-shake-and-drink.com/. Powder supplement soluble in liquid to be added to normal beverages or in gel preparations. Can also be added to solid food as micro-encapsulation ensures that the unpleasant taste of the formulation is not released onto the palate. As stated in the previous sections, this amounts to a strategy on which it is difficult to model normal eating habits; the supplement mixed into food is still perceived as a nuisance. ii. https://www.nutricia.it/prodotti/hom-2-secunda/. This is also a supplement which is to be added in a set amount to normal foods, or diluted in beverages. As stated in the previous sections, this amounts to a strategy on which it is difficult to model normal eating habits; the supplement mixed into food is still perceived as a nuisance.
[0017] International patent application WO2017/069629 describes a special compound of Omega 3 fatty acids supplemented with Pyrimidine and other substances, such as vitamins, with the aim of reducing the amount of Phenylalanine in the blood of patients affected by Phenylketonuria. However this Application does not describe or suggest how this compound can be made into a form suitable for oral administration such that it is completely comparable, in terms of taste and appeal, with normal food sold on the market by the food industry, even though Claim no. 14 states the possibility of taking the compound featuring in the Invention by mouth.
[0018] Application WO2018/014920 describes the formulation and method for producing a recombinant protein, which is created outside of its natural environment, and including it in a diet for people which has no Phenylalanine. Additionally, this protein can be absorbed as a high-grade protein. In this case too these special formulations and production methods are not integrated with the necessary solutions for these substances to produce foods with none of the issues stated in the previous sections, especially in relation to taste.
[0019] It appears from the Prior Art, and the set of issues described in previous sections, that the solution is partial and ineffective, even considering additional products, studies or documents available in the Prior Art, such as the product Country Sunrise All Purpose Baking Mix from PKU PROSPECTIVES, or the contents of the scientific publication Strategies Used in Production of Phenylalanine-Free Foods for PKU Management by Nafiseh Soltanizadeh and Leila Mirmoghtadaie et al., or the information provided in LIS2016184271 . [0020] The products from PKU PROSPECTIVES are based on low-protein recipes, which are currently deemed to be unsuitable and harmful for the body when consumed over the long term, especially by children and young people who are still developing.
[0021 ] The scientific publication by Nafiseh Soltanizadeh and Leila Mirmoghtadaie states that eliminating Phenylalanine from the group of amino acids, which is a necessary process when creating food suitable for Phenylketonuria sufferers, makes it difficult to produce food that is palatable and appetising (see Conclusion section), a fact which is also highlighted in the background to this Invention.
[0022] Application LIS2016184271 shows amino acid manipulation for managing neurogenetic conditions at a nutritional level, but it does not entirely relate to Phenylketonuria and the range of solutions that it is desirable to achieve when creating food, as stated in this patent application.
[0023] Another important consideration comes from recent studies carried out on patients suffering from Phenylketonuria e.g. Phenylketonuria Diet Promotes Shifts in Firmicutes Populations; Frontiers in Cellular and Infection Microbiology - https://pubmed.ncbi.nlm.nih.gov/31058098/ - April 2019 - Giulia Bassanini, Camilla Ceccarani, Francesca Borgo, Marco Severgnini, Valentina Rovelli, Giulia Morace, Elvira Verduci, Elisa Borghi.
[0024] This scientific publication outlines how the low-Phenylalanine diet for sufferers of Phenylketonuria has an increase in sugars which promote a change in the availability of substances that give rise to fermentation processes developed by micro-organisms present in the intestine.
[0025] Basically this study shows that in people affected by Phenylketonuria (or PKU) who are on a specific diet, a change in the gut microbiome can be detected. The study was conducted with two groups each with twenty-one subjects between the ages of four and eighteen years old, amounting to a total of forty-two people. A large amount of the bacteria Blautia and Clostridium was detected in subjects with hyperphenylalaninemia. Clostridium is known to cause diarrhoea, colitis and abdominal pain. A considerable reduction in the bacteria known as Faecalibacterium was also observed. [0026] The study therefore shows that, in spite of the subjects with Phenylketonuria (or PKU) consuming a diet which is almost vegan and contains foods with a lot of fibre, the structure of their microbiome is still altered, leading to the conclusion that the quality and quantity of sugars consumed in a diet for this condition must be controlled carefully.
[0027] A decisive improvement on the current situation with the Prior Art is the recipe devised in IT 102023000001641 , for which this patent application claims priority, to produce Phenylalanine-free foods that are tasty and appetising, and contain the right mix of protein, fibre and carbohydrate.
[0028] This recipe can be used to make sweet or savoury products, and can be adapted for use in a non-industrial environment, in a domestic setting for example.
[0029] The recipe is based on the use of RS4 modified starch of gluten-free wheat and a mix of ingredients which, with respect to the Prior Art, makes it possible to obtain: i. sweet and savoury foods devised for Phenylketonuria sufferers that taste better than similar products, thanks to the combined effect of the individual ingredients, as claimed, ii. sweet and savoury foods that do not change the gut microbiome as a result of long-term consumption, iii. sweet and savoury foods that enable the control of postprandial glycaemia.
[0030] As per the priority claimed in IT 102023000001641 , the two recipe formulations have a significant element in common i.e. the presence of the entire amino acid spectrum made up of the proteins excluding Phenylalanine, because they are aimed at patients suffering from Phenylketonuria (or PKU), as stated in the previous sections.
[0031 ] As per the priority claimed in IT 102023000001641 , the two recipe formulations have another element in common i.e. the presence of the RS4 modified starch of gluten-free wheat within the general category of carbohydrates - required for the body to produce energy via the Kreb's Cycle - at a percentage equal to or greater than 14% of the total amount of carbohydrates used. The use of the modified starch is essential for mitigating postprandial glycaemia. [0032] The reason for using RS4 modified starch of gluten-free wheat is due to observing that patients suffering from Phenylketonuria (or PKU) tend to consume large amounts of simple or complex carbohydrates, because they can't consume protein, and these can result in a predisposition to, and the full-blown occurrence of, hyperglycaemia and diabetes.
[0033] As per the priority claimed in IT 102023000001641 , another element common to the three recipe formulations is the presence of prebiotic fibre at a percentage that varies between 7% and 28% in 100 g of the product, and is preferably 15%.
[0034] As per the priority claimed in IT 102023000001641 , the presence of a suitable amount of prebiotic fibre in the recipe formulation is aimed at controlling issues resulting from changes in the gut microbiome in patients suffering from Phenylketonuria (or PKU). This prebiotic fibre restricts the proliferation of bacteria that negatively affect function of the intestine and the immune system.
[0035] As per the priority claimed in IT 102023000001641 , the presence of prebiotic fibre also contributes to the creation of the chyme and so lowers the glycaemic rating.
[0036] As per the priority claimed in IT 102023000001641 , another element common to the two recipe formulations is the presence of a suitable amount of polyphenols, which bring about processes that mitigate gut inflammation.
[0037] As per the priority claimed in IT 102023000001641 , another element common to the two recipe formulations is the use of a masking agent, which differs conceptually to flavouring as it aims to eliminate the residual component with the unpleasant taste caused by a lack of Phenylalanine in the group of amino acids.
[0038] As per the priority claimed in IT 102023000001641 , each of the two formulations is suitable for making dry foods or foods with RH between 5% and 30%.
[0039] Although the products created using the recipe in IT 102023000001641 are an improvement on the Prior Art, an additional quality aspect not related to the metabolic effectiveness of these foods can also be developed.
[0040] Basically the sweet and savoury products made using the recipe in IT 102023000001641 may have resistance to mechanical stress that is incompatible with industrial packaging and distribution processes in the food industry, especially when RH is very low or the products are classed as dry food.
[0041 ] It is generally known that, when packaging and transporting similar items such as breadsticks, biscuits, crackers, tarts etc., handling the boxes and packets results in stress that can damages the goods.
[0042] Furthermore, food fragility is an aspect that also affects consumption, and it is generally known that the handling procedures required with these products should not alter the integrity of the goods and cause them to break or crumble.
[0043] Crumbling and a lack of bite in food also affect the pleasure of eating, as crunchiness is a feature of culinary science that is specially calculated to create a pleasant contrast on the palate.
[0044] Another area of optimisation in this patent application is a special recipe formulation for patients suffering from Phenylketonuria on the basis of age and gender.
[0045] The aim of this Invention is therefore to devise a process for making the recipe in IT 102023000001641 such that some aspects are enhanced further, in particular to make it less crumbly and more palatable.
Summary of the Invention
[0046] The Invention describes an innovative process to optimise the production of the recipe claimed in IT 102023000001641 for creating specific foods for patients suffering from Phenylketonuria. These foods are highly appetising and appealing with a taste that is comparable to normal food produced in the retail food industry. The Invention enables the production of food without the structural fragility that would prevent it from being packaged and transported in the food industry, and from being enjoyed by the patients consuming it. The Invention also describes specific recipe formulations for patients suffering from Phenylketonuria on the basis of factors relating to age and lifestyle.
Benefits of the Invention
[0047] The main benefits of the Invention are listed below: i. the foods produced as per the idea of the Invention are sufficiently robust such that they can be packaged and transported in the retail food industry; ii. the foods obtained as per the idea of the Invention do not break or crumble when consumed by patients; iii. the foods obtained as per the idea of the Invention comply with the nutritional requirements of patients suffering from Phenylketonuria and are crunchy; iv. thanks to the foods produced as a result of the Invention, patients suffering from Phenylketonuria (or PKU) will no longer have to consume supplements with an unpleasant taste, or augment a low-protein diet with the aforementioned supplements; v. the foods produced as a result of the Invention cover the full range of sweet and savoury foods; vi. the taste of foods produced as per the idea of the Invention is comparable with foods already available in the normal food supply chain; vii. the foods produced as per the idea of the Invention effectively control patient microbiome; viii. the foods produced as per the idea of the Invention limit postprandial glycaemia; ix. the foods produced as per the idea of the Invention are suited to patients suffering from Phenylketonuria who need to manage their lean body mass.
Description of Diagrams
[0048] Table with diagrams not included.
Description of the Invention
[0049] A description of the various ways of implementing this Invention is discussed here for illustration and is not intended to be exhaustive or limited to the form of implementation described. [0050] All potential obvious modifications to the Invention and its field of application implemented by industry experts do not limit the actual patent protection conditions.
[0051 ] As per the Invention implementation method, innovative elements are included in the recipe claimed in IT 102023000001641 to optimise the results and improve the benefits significantly, thereby creating a pre-treatment for some ingredients in the aforementioned recipe.
[0052] As per the Invention implementation method, the process in this Invention aims to create a nutritional precursor i.e. a semi-finished RS4 product obtained from the RS4 modified starch of gluten-free wheat already used in the recipe in IT 102023000001641.
[0053] In IT 102023000001641 the aforementioned starch is used directly as obtained from packets on the food market. The RS4 modified starch of gluten-free wheat comes in powder form and constitutes the base for adding all other ingredients to create the food recipes.
[0054] This method of using the starch does not contribute to forming a nutritional mix that is structurally effective for creating foods in which, after the final cooking or drying phase, the characteristics of crunchiness or mechanical resistance are comparable with foods on the market not aimed at patients suffering from Phenylketonuria.
[0055] To address the aspect stated in 0054, and as per the procedure in this Invention, RS4 modified starch of gluten-free wheat is put into a mechanical mixer used to mix dough in the food industry.
[0056] As per the procedure in this Invention, an exact amount of water is added to the RS4 modified starch of gluten-free wheat to form a precise starch/F ratio.
[0057] As per the procedure in this Invention, the starch/H2O ratio may vary from a minimum of 0.5 to a maximum of 0.90.
[0058] As per the procedure in this Invention, the temperature of the water added to the RS4 modified starch of gluten-free wheat is 100°C, however water at a temperature in the range of 90°C to 100°C can be used. [0059] As per the procedure in this Invention, the starch and water can now start to be mixed with the mechanical mixer.
[0060] As per the procedure in this Invention, the mixing process lasts for between 120 and 240 seconds, which is the time required for the RS4 modified starch of gluten- free wheat in contact with the water to acquire the physical/mechanical characteristics of the semi-finished RS4 product i.e. i. a solid form; ii. a non-sticky surface; iii. a compact, cohesive appearance, damp to touch but not wet; iv. malleable; v. a shape that doesn't tend to correspond to that of the container.
[0061 ] The achievement of the physical/mechanical characteristics specified in 0060 defines the semi-finished RS4 product as per the procedure in this Invention.
[0062] As per the procedure in this Invention, the semi-finished RS4 product acquires these physical characteristics thanks to the soluble fibres forming the RS4 modified starch of gluten-free wheat linking together. This process is facilitated by the mechanical action of the mixer and the temperature of the water with which it is mixed, lengthening the insoluble fibres to encourage them to link and intertwine.
[0063] As per the procedure in this Invention, the insoluble fibres create a three- dimensional structure which traps most of the water, thereby facilitating the creation of well-defined physical characteristics in the semi-finished RS4 product as described in section 0060.
[0064] The insoluble fibre arrangement resulting from the procedure in this Invention does not therefore facilitate the creation of a liquid semi-finished product or an emulsion.
[0065] As per the procedure in this Invention, a fluctuation in physical environmental parameters (humidity and temperature levels at which the RS4 modified starch of gluten-free wheat is stored, salts dissolved in the water etc.) may affect the timescales for making the semi-finished RS4 product specified in section 0060. As a result, the process can also be deemed as finished when the semi-finished RS4 product acquires the physical/mechanical characteristics specified in 0060 even if not within the timescales indicated.
[0066] As per the procedure in this Invention, the RS4 modified starch of gluten-free wheat and water can be mixed together in a sealed container with an internal air pressure greater than atmospheric pressure, to accelerate the processing time.
[0067] As per the procedure in this Invention, the semi-finished RS4 product can also reduce the sensation on the palate linked to the unpleasant odour typical of the RS4 modified starch of gluten-free wheat.
[0068] As per the procedure in this Invention, the semi-finished RS4 product can now be removed from the mechanical mixer and used to make the recipes in IT 102023000001641. The linking between the soluble fibres will enable the nutritional preparations to withstand mechanical stress in the final cooking phase, and to retain the physical characteristics that prevent crumbling: i. when further processed to add ingredients (decoration, dusting, icing etc.) using manual or mechanical procedures; ii. when packaged for distribution in the food sector; iii. when consumed by patients suffering from Phenylketonuria.
[0069] As per the procedure in this Invention, the use of the semi-finished RS4 product also offers clear benefits when producing soft sweet and savoury goods, such as pies, muffins etc., or those with a high RH level. The insoluble fibre arrangement in the semi-finished RS4 product resulting from the procedure, and described in the previous sections, enables the food mixture to be cohesive even when the relative humidity is much higher than goods defined as dry products. After cooking the recipes created as specified in IT 102023000001641 , this characteristic also prevents food with a high RH level from crumbling undesirably when consumed by patients.
[0070] As per the Invention implementation method, the resistance to mechanical stress obtained by the food by using the semi-finished RS4 product to stop it from crumbling, also gives it a bite and makes it crunchy. This feature is highly desirable in food as it results in a more pleasurable eating experience. For example, soft fillings can be contrasted with the increased crunchiness of surrounding pastry, avoiding the cloying sensation perceived with the soft part of filled items. As already stated in IT 102023000001641 , the aim of this patent is to create specific foods for patients suffering from Phenylketonuria that are as enjoyable and tasty as normal foods available in the retail food industry, and to avoid the need for supplements and/or foods that lack these pleasurable characteristics.
[0071 ] As per the Invention implementation method, in goods defined as dry products, or those with RH level equal to or less than 5%, such as biscuits, crackers etc., an additional process is used after the food is cooked and before it is finally dried.
[0072] As per the Invention implementation method, this additional process is defined as a consolidation period. The consolidation period is after the food has been cooked in the oven and before it undergoes the final drying phase. The food is kept in an atmosphere with a temperature of no greater than 24°C for between 4 and 24 hours. This process makes the mixture obtained with the semi-finished RS4 product more solid and robust.
[0073] As per the Invention implementation method, the consolidation period also ensures that the subsequent drying phase does not cause crumbling or breakage, as such phenomena are already limited by the presence of the semi-finished RS4 product in the mixture.
[0074] As per the Invention implementation method, the following amino acid amounts, excluding Phenylalanine, are used on the basis of 100 g of each of the two recipes, one for sweet and one for savoury goods, as stated in IT 102023000001641 : i. L-serine 900 mg ii. L-threonine 1200 mg iii. L-leucine 2900 mg iv. L-glycine 1250 mg v. L-alanine 900 mg vi. L-arginine 1100 mg vii. L-cystine 650 mg viii. L-glutamine 4600 mg ix. L-histidine 700 mg x. L-aspartic acid 1800 mg xi. L-proline 1600 mg xii. L-isoleucine 1800 mg xiii. L-lysine 1700 mg xiv. L-tryptophan 500 mg xv. L-valine 1700 mg xvi. L-methionine 600 mg xvii. L-tyrosine 2500 mg xviii. L-carnitine 150 mg
[0075] FORMULATION OF RECIPES FOR THE PRODUCTION OF SAVOURY
BAKED GOODS AS PER THE IDEA OF THE INVENTION
[0076] As per the Invention implementation method, the recipe for making 100 g of savoury baked goods using the innovative process to create the semi-finished RS4 product is as follows: i. Amino acids - as specified in section 0055 ii. RS4 modified starch of gluten-free wheat in the form of the semi-finished RS4 product 6.00 g iii. Corn starch 12.90 g iv. Potato starch 14.00 g v. Guar gum 2.00 g vi. Tara gum 2.50 g vii. Bamboo fibre 2.00 g viii. FOS fibre 1.50 g ix. Psyllium fibre 0.60 g x. Acacia fibre 1.00 g xi. Arabinoxylan fibre 2.00 g xii. Bromelain 0.45 g xiii. Sunflower oil 18.00 g
[0077] As per the priority claimed in IT 102023000001641 , the following alternative ingredients can be used in the formulation of the recipe for savoury baked goods: a) rice starch b) tapioca flour c) IMO d) polydextrose e) isomaltulose f) rice flour g) starches in general.
[0078] As per the priority claimed in IT 102023000001641 , the following alternative sources of fibre can be used in the formulation of the recipe for savoury baked goods: a) oat fibre b) citrus fibre c) cocoa fibre d) honey fibre e) hazelnut fibre f) additional sources of soluble and insoluble fibre.
[0079] As per the priority claimed in IT 102023000001641 , the following additional ingredients can be used in the formulation of the recipe for savoury baked products: i. Extra virgin olive oil 10.00 g ii. Butter 11.00 g iii. Raising agents (diphosphates, sodium carbonate, ammonium bicarbonate) 1 .60 g iv. Raising agents (Ammonia) 1.20 g v. Flavourings 3.30 g vi. Masking agent 2.00 g vii. Mono and diglycerides 1 .20 g viii. Antioxidant: Alpha-tocopherol 0.20 g ix. Salt 1.00 g
[0080] FORMULATION OF RECIPES FOR THE PRODUCTION OF SWEET BAKED GOODS AS PER THE IDEA OF THE INVENTION
[0081 ] As per the priority claimed in IT 102023000001641 , and using the procedure in this Invention designed to create the semi-finished RS4 product, the recipe for making 100 g of sweet baked goods is as follows: i. Amino acids - as specified in section 0055 ii. RS4 modified starch of gluten-free wheat in the form of the semi-finished RS4 product 6.00 g iii. Corn starch 9.00 g iv. Potato starch 9.00 g v. Guar gum 2.00 g vi. Tara gum 2.00 g vii. Bamboo fibre 1.50 g viii. FOS fibre 1.50 g ix. Psyllium fibre 0.60 g x. Acacia fibre 0.50 g xi. Arabinoxylan fibre 2.00 g xii. Erythritol 14.00 g xiii. Sunflower oil 17.80 g
[0082] As per the priority claimed in IT 102023000001641 , the following alternative ingredients can be used in the formulation of the recipe for sweet baked goods: a) rice starch b) tapioca flour c) IMO d) polydextrose e) isomaltulose f) rice flour g) starches in general.
[0083] As per the priority claimed in IT 102023000001641 , the following alternative sources of fibre can be used in the formulation of the recipe for sweet baked goods: a) oat fibre b) citrus fibre c) cocoa fibre d) honey fibre e) hazelnut fibre f) additional sources of soluble and insoluble fibre.
[0084] As per the priority claimed in IT 102023000001641 , additional ingredients are present in the formulation of the recipe for sweet baked products: i. Extra virgin olive oil 10.00 g ii. Butter 9.00 g iii. Raising agents (diphosphates, sodium carbonate, ammonium bicarbonate) 1.00 g iv. Raising agents (Ammonia) 0.70 g v. Flavourings 1.00 g vi. Masking agent 2.00 g vii. Emulsifying agent (Soy lecithin) 0.60 g viii. Antioxidant (Alpha-tocopherol) 0.20 g ix. Bromelain 0.45 g x. Salt 0.2 g
[0085] As per another Invention implementation method, the amino acid formulation specified in 0074 and 0081 can easily be adapted for patients requiring sports nutrition, or a diet to increase lean body mass, or patients suffering from age- related sarcopenia.
[0086] The amounts of amino acids that can be used in the recipes in this Invention to make sweet and savoury goods as part of a nutritional plan for patients participating in sport are as follows: i. L-serine 780 mg ii. L-threonine 1080 mg iii. L-leucine 4000 mg iv. L-glycine 1120 mg v. L-alanine 770 mg vi. L-arginine 980 mg vii. L-cystine 520 mg viii. L-glutamine 4500 mg ix. L-histidine 600 mg x. L-aspartic acid 1800 mg xi. L-proline 1590 mg xii. L-isoleucine 2000 mg xiii. L-lysine 1600 mg xiv. L-tryptophan 500 mg xv. L-valine 2000 mg xvi. L-methionine 500 mg xvii. L-tyrosine 2500 mg xviii. L-carnitine 160 mg
[0087] The amounts of amino acids that can be used in the recipes in this Invention to make sweet and savoury goods as part of a nutritional plan for patients suffering from age-related sarcopenia are as follows: i. L-serine 775 mg ii. L-threonine 1077 mg iii. L-leucine 4500 mg iv. L-glycine 1127 mg v. L-alanine 778 mg vi. L-arginine 978 mg vii. L-cystine 525 mg viii. L-glutamine 4500 mg ix. L-histidine 600 mg x. L-aspartic acid 1700 mg xi. L-proline 1700 mg xii. L-isoleucine 1800 mg xiii. L-lysine 1600 mg xiv. L-tryptophan 450 mg xv. L-valine 1780 mg xvi. L-methionine 500 mg xvii. L-tyrosine 2460 mg xviii. L-carnitine 150 mg
Invention examples
[0088] The recipes described in this Invention are suitable for making foods such as: i. Biscuits ii. Muffins iii. Tarts iv. Snacks v. Bread vi. Pizza vii. Pasta viii. Crackers ix. Sweet and savoury pies x. Baked goods in general.
Industrial Applications of the Invention
[0089] The industrial application for the idea of the Invention concerns the food industry, in particular all sectors that produce baked or semi-baked goods.
[0090] The sectors specified can use the recipes in this Invention to produce foods that are extremely appetising and tasty and meet the nutritional requirements of patients suffering from Phenylketonuria.
Citations in the Invention
[0091] Citation List follows: none.
Patent Literature
[0092] PTL1 : WO2017069629
[0093] PTL2: WO2018/014920
[0094] PTL3: US2016184271
Non-Patent Literature
[0095] NPL1 : https://www.osservatoriomalattierare.it/malattie-rare/fenilchetonuria- pku/14959-fenilchetonuria-la-malattia-metabolica-piu-diffusa-oggi-il-world-pku- day
[0096] NPL2: https://www.golike-shake-and-drink.com/
[0097] NPL3: https://www.nutricia.it/prodotti/hom-2-secunda/ [0098] NPL4: Phenylketonuria Diet Promotes Shifts in Firmicutes Populations;
Frontiers in Cellular and Infection Microbiology https://pubmed.ncbi.nlm.nih.gov/31058098/ - April 2019 - Giulia Bassanini, Camilla Ceccarani, Francesca Borgo, Marco Severgnini, Valentina Rovelli, Giulia Morace, Elvira Verduci, Elisa Borghi.
[0099] NPL5: https://www.pkuperspectives.com
[0100] NPL6: Strategies Used in Production of Phenylalanine-Free Foods for PKU Management by Nafiseh Soltanizadeh and Leila Mirmoghtadaie.
Priority Claimed [0101 ] IT 102023000001641

Claims

Claims [Claim 1 ] Process for the realization of a food composition for making sweet and salted baked preparations suitable for the feeding of patients with Phenylketonuria (PKU) based on the realization of a food precursor called “semi-finished products RS4”, said semi-finished product RS4 made from modified gluten-free wheat RS4 starch in which: a. the semi-finished product RS4 is obtained by the following process: i. the modified gluten-free wheat RS4 starch is placed in an industrial kneading machine, ii. water at a temperature between 90°C and 100°C is added to the modified gluten-free wheat RS4starch, iii. the amount of water added is dosed to realize a starch/water ratio between 0, 50 and 0, 90, iv. the kneader operates the mixing of the modified gluten-free wheat RS4 starch with water until the following conditions occurs:
1 . for a time between 120s and 240s, preferably 180s,
2. for as long as it takes for the insoluble fibers of the modified gluten-free wheat RS4 starch to intertwine with each other until they determine in the semi-finished product: a. a solid shape, b. a non-adhesive surface, c. a compact and cohesive appearance, moist to the touch but not wet, d. malleable, e. a shape that not to take the one of the vessel that contains it. b. in the process of realization of the food composition a procedure, called “consolidation pause” is applied, in which: i. the consolidation pause is applied to the food compositions in which the residual moisture RH of the finished product is equal/less than 5%, ii. the consolidation pause is applied after the cooking of the food, iii. the consolidation pause is applied before the drying phase of the food, iv. the consolidation pause consists of stationing the finished product at a temperature no higher than 24°C for a time between 4 hours and 24 hours.
[Claim 2] Food composition obtained using the process of Claim 1 wherein: a. a first formulation is suitable for the realization of salted baked goods, b. a second formulation is suitable for the realization of sweet baked goods, c. in each of the two formulations the semi-finished products RS4 is made using 6g of modified gluten-free wheat RS4 starch on 100 gr of product, d. in each of the two formulations the presence of fibers is between 7% and 28% on 100 grams of product, preferably 15%, e. each of the two formulations is suitable for the realization of dry foods with RH equal/less than 5% and food with RH between 5% and 30%.
[Claim 3] Food composition for making salted baked goods obtained using the process of Claim 1 composed per 100 grams of product of: a. Amino acids: i. L-serine: 900 mg ii. L-threonine: 1200 mg iii. L-leucine: 2900 mg iv. L-glycine: 1250 mg v. L-alanine: 900 mg vi. L-arginine: 1100 mg vii. L-cystine: 650 mg viii. L-glutamine: 4600 mg ix. L-histidine: 700 mg x. L-aspartic acid: 1800 mg xi. L-proline: 1600 mg xii. L-isoleucine: 1800 mg xiii. L-lysine: 1700 mg xiv. L-tryptophan: 500 mg xv. L-valine: 1700 mg xvi. L-methionine: 600 mg xvii. L-tyrosine: 2500 mg xviii. L-carnitine: 150 mg b. modified gluten-free wheat Starch in the form of semi-finished products RS4: 6, 00 gr c. Corn starch: 12,90 gr d. Potato starch: 14,00 gr e. Guar gum: 2,00 gr f. Tare gum: 2,50 gr g. Bamboo fibre: 2,00 gr h. FOS fibre: 1 ,50 gr i. Psyllium fibre: 0,60 gr j. Acacia fibre: 1 ,00 gr k. Arabonoxylane fibre: 2,00 gr l. Bromelain: 0,45 gr m. Sunflower oil: 18,00 gr n. Diphosphates, Sodium Carbonates, Ammonium bicarbonate: 1 ,60gr o. Ammonia: 1 ,20 gr p. Aromas: 3,30 gr q. Masking: 2,00 gr r. Monodiglycerides 1 ,20 gr s. Alpha-tocopherol: 0,20gr t. Salt: 1 ,00 gr.
[Claim 4] Food composition of Claim 3 which uses the following alternative fibers and alternative ingredients: a. Rice starch b. Extra virgin Olive oil c. Tapioca flour d. IMO e. Polydextrose f. Isomaltulose g. Rise flour h. Other types of starch i. Oat fibre j. Citrus fibre k. Cocoa fibre l. Apple fibre m. Hazelnut fibre n. Soluble and insoluble Fibers
[Claim 5] Food composition for making sweet baked goods obtained using the process of Claim 1 composed per 100 grams of product of: a. Amino acids: i. L-serine: 900 mg ii. L-threonine: 1200 mg iii. L-leucine: 2900 mg iv. L-glycine: 1250 mg v. L-alanine: 900 mg vi. L-arginine: 1100 mg vii. L-cystine: 650 mg viii. L-glutamine: 4600 mg ix. L-histidine: 700 mg x. L-aspartic acid: 1800 mg xi. L-proline: 1600 mg xii. L-isoleucine: 1800 mg xiii. L-lysine: 1700 mg xiv. L-tryptophan: 500 mg xv. L-valine: 1700 mg xvi. L-methionine: 600 mg xvii. L-tyrosine: 2500 mg xviii. L-carnitine: 150 mg b. modified gluten-free wheat Starch in the form of semi-finished products RS4: 6, 00 gr c. Corn starch: 9,00 gr d. Potato starch: 9,00 gr e. Guar gum: 2,00 gr f. Tare gum: 2,00 gr g. Bamboo fibre: 1 ,00 gr h. FOS fibre: 1 ,50 gr i. Psyllium fibre: 0,60 gr j. Acacia fibre: 0,50 gr k. Arabonoxylane fibre: 2,00 gr l. Erythrole: 14,00 gr m. Sunflower oil: 17,80 gr n. Leavening agents: 1 ,90 gr o. Diphosphates, Sodium Carbonates, Ammonium bicarbonate: 1 ,00gr p. Ammonia: 0,70 gr q. Aromas: 1 ,00 gr r. Masking: 2,00 gr s. Soy lecithin: 0,60 gr t. Alpha-tocopherol: 0,20gr u. Bromelain: 0,45 gr v. Salt: 0,20 gr
[Claim 6] Food composition of Claim 5 which uses the following alternative fibers and alternative ingredients: a. Rice starch b. Extra virgin Olive oil c. Tapioca flour d. IMO e. Polydextrose f. Isomaltulose g. Rise flour h. Other types of starch i. Oat fibre j. Citrus fibre k. Cocoa fibre
I. Apple fibre m. Hazelnut fibre n. Soluble and insoluble Fibers.
[Claim 7] Food composition of Claims 3 and 5 in which the set of Amino acids is weighted for patients suffering from Phenylketonuria and Sarcopenia according to the following doses: a. L-serine: 775 mg b. L-threonine: 1077 mg c. L-leucine: 4500 mg d. L-glycine: 1127 mg e. L-alanine: 778 mg f. L-arginine: 978 mg g. L-cystine: 525 mg h. L-glutamine: 4500 mg i. L-histidine: 600 mg j. L-aspartic acid: 1700 mg k. L-proline: 1700 mg l. L-isoleucine: 1800 mg m. L-lysine: 1600 mg n. L-tryptophan: 450 mg o. L-valine: 1780 mg p. L-methionine: 500 mg q. L-tyrosine: 2460 mg r. L-carnitine: 150 mg.
[Claim 8] Food composition of Claims 3 and 5 in which the set of Amino acids is weighted for the increase in lean mass in patients suffering from Phenylketonuria who practice sports activities, according to the following doses: a. L-serine: 780 mg b. L-threonine: 1080 mg c. L-leucine: 4000 mg d. L-glycine: 1120 mg e. L-alanine: 770 mg f. L-arginine: 980 mg g. L-cystine: 520 mg h. L-glutamine: 4500 mg i. L-histidine: 600 mg j. L-aspartic acid: 1800 mg k. L-proline: 1590 mg l. L-isoleucine: 2000 mg m. L-lysine: 1600 mg n. L-tryptophan: 500 mg o. L-valine: 2000 mg p. L-methionine: 500 mg q. L-tyrosine: 2500 mg r. L-carnitine: 160 mg.
[Claim 9] Food composition of Claims 3, 5, 7 and 8 used for the production of: a. Biscuits, b. Muffin, c. Tarts, d. Snacks, e. Bread, f. Pizza, g. Pasta, h. Crackers, i. savory and sweet pies, j. bakery products in general.
PCT/IB2024/000012 2023-02-01 2024-01-29 Procedure for creating a recipe for patients suffering from phenylketonuria WO2024161209A1 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
IT102023000001641 2023-02-01
IT102023000001641A IT202300001641A1 (en) 2023-02-01 2023-02-01 IMPROVED FOOD RECIPE FOR PHENYLKETONURIA PATIENTS
IT202400001281 2024-01-24
IT102024000001281 2024-01-24

Publications (1)

Publication Number Publication Date
WO2024161209A1 true WO2024161209A1 (en) 2024-08-08

Family

ID=90361492

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2024/000012 WO2024161209A1 (en) 2023-02-01 2024-01-29 Procedure for creating a recipe for patients suffering from phenylketonuria

Country Status (1)

Country Link
WO (1) WO2024161209A1 (en)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050129823A1 (en) * 2003-11-07 2005-06-16 Dohl Christopher T. Composition and method for making high-protein and low-carbohydrate food products
US20100215825A1 (en) * 2005-06-22 2010-08-26 Roquette Freres Fiber-rich baked product and method for the production thereof
JP2014068620A (en) * 2012-10-01 2014-04-21 Matsutani Chem Ind Ltd Food product blended with insoluble dietary fiber, and manufacturing method thereof

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050129823A1 (en) * 2003-11-07 2005-06-16 Dohl Christopher T. Composition and method for making high-protein and low-carbohydrate food products
US20100215825A1 (en) * 2005-06-22 2010-08-26 Roquette Freres Fiber-rich baked product and method for the production thereof
JP2014068620A (en) * 2012-10-01 2014-04-21 Matsutani Chem Ind Ltd Food product blended with insoluble dietary fiber, and manufacturing method thereof

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
ANONYMOUS: "The Grammarphobia Blog: When biscuits were baked twice", 12 February 2018 (2018-02-12), pages 1 - 2, XP093156815, Retrieved from the Internet <URL:https://www.grammarphobia.com/blog/2018/02/biscuit.html> *
MILLER REBECCA A. ET AL: "Effect of RS4 Resistant Starch on Dietary Fiber Content of White Pan Bread", CEREAL CHEMISTRY, 1 March 2017 (2017-03-01), US, pages 185 - 189, XP055789510, ISSN: 0009-0352, Retrieved from the Internet <URL:https://onlinelibrary.wiley.com/doi/pdfdirect/10.1094/CCHEM-03-16-0048-R> DOI: 10.1094/CCHEM-03-16-0048-R *
NAFISEH SOLTANIZADEH ET AL: "Strategies Used in Production of Phenylalanine-Free Foods for PKU Management", COMPREHENSIVE REVIEWS IN FOOD SCIENCE AND FOOD SAFETY, vol. 13, no. 3, 16 May 2014 (2014-05-16), US, pages 287 - 299, XP055234111, ISSN: 1541-4337, DOI: 10.1111/1541-4337.12057 *

Similar Documents

Publication Publication Date Title
Berti et al. Effect on appetite control of minor cereal and pseudocereal products
ES2281011T3 (en) TEFF FLOUR PROCESSING.
Goel et al. Wheat proteins: a valuable resources to improve nutritional value of bread
JP2008079606A (en) Raw material powder for processed foods
CN108308236A (en) Quinoa shortbread type biscuit and preparation method thereof
WO2015071854A1 (en) Method for preparing a bread dough and bread dough obtained thereby
AU2010272537B2 (en) Low glycaemic index baked product comprising high levels of fibre, proteins and inclusions
CN102960404A (en) Buckwheat cake and making method thereof
Mayangsari et al. Effect of supplementation of F100 biscuits modified with moringa oleifera flour substitution on nutritional status of under-five children with malnutrition in Kendari City Indonesia
JP5931350B2 (en) Baked confectionery having sleep improving action and premix for the baked confectionery
RU2731578C1 (en) Gluten-free dry mixture using rice and amaranth flour and vegetable and berry powders and a cookie production method
CN103004925A (en) Buckwheat walnut cake and preparation method thereof
EP2001310B1 (en) Supplement mixture for dietetic food destined for celiacs
CN108077359A (en) A kind of full coarse cereal cake and preparation method thereof
Sana et al. Influence of soy flour in baked products
WO2024161209A1 (en) Procedure for creating a recipe for patients suffering from phenylketonuria
WO2024160654A1 (en) Enhanced recipe for patients suffering from phenylketonuria
CN105851136A (en) Moringa seed healthcare salty bread and preparation method thereof
KR20170039862A (en) The method of manufacture for garlic bread
KR20170035573A (en) Glutinous barley bread comprising black garlic and the processing method of the same
US20200107564A1 (en) Mix for foodstuff, foodstuff, method and use
JP2015142542A (en) High protein pancake mix
Puspita et al. “TIS Biscuit” with High Content of Amino Acid and Mineral to Prevent Stunting
Niharika et al. Development of insantmuffin mix enriched with calcium (chickeneggshell)
Manivel Nutritional and sensory evaluation of Moringa oleifera cookies

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 24709160

Country of ref document: EP

Kind code of ref document: A1