Special medical purpose formula food for improving bioavailability of stable amino acid and application thereof

Abstract

The invention provides a special medical purpose formula food for improving the bioavailability of stable amino acid and application of the special medical purpose formula food. The invention firstly provides the formula food for the special medical purpose, the formula food for the special medical purpose comprises alpha-lactalbumin, linoleic acid and prebiotics, and the mass ratio of the alpha-lactalbumin to the linoleic acid to the prebiotics is (0.25-0.6): 1: (0.1-0.96). The formula food for the special medical purpose can improve the bioavailability of stable amino acid.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of special medical use formula food, and particularly relates to a special medical use formula food containing α-lactalbumin, linoleic acid and prebiotics, which can improve the bioavailability of stable amino acids and related applications. BACKGROUND

[0002] Premature infants or low birth weight infants need special nutritional support after birth to help them catch up with growth outside the mother's body because they are not fully developed at birth. The infant and toddler period is the most rapid stage of growth and development after the fetal period, and sufficient nutrients need to be ingested to maintain the high metabolism and growth and development needs. Protein is an important nutrient for the growth and development of infants and toddlers. Protein intake in the early infant period is crucial to the health of infants and will affect growth, body composition, neurodevelopment, appetite and hormone regulation. Protein digestion problems can lead to short-term and long-term adverse consequences, such as pain, diarrhea, intolerance, allergy, malabsorption and constipation. Studies have shown that developmental delay in early childhood is associated with lower levels of essential amino acid circulation in the body. After increasing the serum amino acid (especially branched-chain amino acid) level, the length-for-age Z score of the young child significantly improves. However, it is not true that the higher the protein intake, the better. Studies have also shown that early life protein intake is associated with overweight, obesity and chronic disease prevalence in adulthood, but the underlying mechanisms remain to be further explored. Therefore, ensuring proper protein digestion and intake is crucial to support the healthy growth of infants.

[0003] However, the gastrointestinal tract of newborns is not fully developed, the digestive tract is short, the secretion of digestive juice and the activity of digestive enzymes are low, and the microbial flora is still in the stage of gradual establishment. The digestive capacity of infants and young children, especially protein nutrients, is far inferior to that of adults. By comparing the digestive environment of the gastrointestinal tract of adults and infants and young children, it is found that under fasting conditions, the pH value of the stomach of newborns is about 3.0-4.0, and as the infant's age increases, the pH value in the stomach can decrease to 1.5-3.0, but there is still a certain difference from the adult stomach pH value of 1.7-1.9. After ingesting food, the pH value of the stomach of infants and young children is about 5.59, which is also higher than that of adults after eating. Pepsin, which is responsible for hydrolyzing proteins in the stomach, has an activity of only 18% of that of adults in the infant period. Under the high pH value of the stomach of infants and young children, the degree of protein digestion in the stomach is limited. The intestine is the main site of protein digestion, and proteins are broken down into amino acids and small peptide fragments by digestive enzymes such as trypsin in the intestine. However, the immature intestine reduces the protein digestion rate. In addition, due to the immature development of the intestinal tract and its barrier, the cells of the intestinal mucosa are sparse, and the intestinal wall has a large permeability. Unhydrolyzed protein molecules may pass through the intestinal mucosa to trigger allergic reactions, diarrhea, intestinal reflux, and affect the growth and development of infants and young children. In addition, dietary lipids and dietary fiber can also affect the digestion and absorption of proteins.

[0004] Amino acids are the building blocks of proteins and essential nutrients for the growth and development of infants and young children. Based on whether they can be synthesized in the body, amino acids can be divided into essential amino acids and non-essential amino acids. Essential amino acids are those that the human body cannot synthesize or whose synthesis rate cannot meet the body's needs, and must be obtained from the diet. These include isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, valine, and histidine. Non-essential amino acids are those that the human body can synthesize and do not need to be obtained from the diet, including aspartic acid, glutamic acid, glycine, proline, serine, cysteine, and tyrosine. Different food proteins vary in the types and amounts of essential amino acids, which can be characterized using amino acid patterns.

[0005] The amino acid composition of cow's milk protein differs significantly from that of breast milk, resulting in relatively low protein quality and low bioavailability of amino acids in infant formula that uses cow's milk as the main protein source.

[0006] Therefore, in the fields of infant formula, children's or adult formula, or special medical purpose formula, there is a need for solutions to improve protein quality and increase the bioavailability of stable amino acids. Summary of the Invention

[0007] One object of the present invention is to provide a special medical purpose food that can improve the bioavailability of stable amino acids.

[0008] Another object of the present invention is to provide the application of the aforementioned food for special medical purposes in improving the bioavailability of stable amino acids.

[0009] On the one hand, the present invention provides a special medical purpose formula food, which contains α-lactalbumin, linoleic acid and prebiotics, wherein the mass ratio of α-lactalbumin, linoleic acid and prebiotics is (0.25-0.6):1:(0.1-0.96).

[0010] According to a specific embodiment of the present invention, the special medical purpose formula food of the present invention can be a liquid food or a solid powder food.

[0011] According to a specific embodiment of the present invention, the special medical purpose formula food of the present invention can be a special medical purpose infant formula food suitable for people aged 0 to 12 months, or a special medical purpose formula food suitable for people over 1 year old.

[0012] According to a specific embodiment of the present invention, the special medical purpose formula food of the present invention is a special medical purpose formula food for premature / low birth weight infants.

[0013] The special medical purpose formula foods of the present invention shall comply with the provisions of the national standards and relevant regulations for special medical purpose formula foods, such as GB 29922 and GB 25596.

[0014] According to a specific embodiment of the present invention, in the special medical purpose formula food of the present invention, the raw material providing the α-lactalbumin of the present invention can be whey protein powder, for example, whey protein powder derived from cow's milk and / or goat's milk. Preferably, the content of α-lactalbumin in such raw material powder is not less than 40%.

[0015] According to a specific embodiment of the present invention, in the special medical purpose formula food of the present invention, α-lactalbumin accounts for 8%-100% of the total protein content of the food.

[0016] According to a specific embodiment of the present invention, the total protein content in the special medical purpose formula food of the present invention can be 6g-36g / 100g of dry matter. For special medical purpose infant formula food, the total protein content is preferably 0.45g-0.7g / 100kJ.

[0017] According to some specific embodiments of the present invention, in the special medical purpose formula food of the present invention, α-lactalbumin accounts for 8%-80% of the total protein content of the food.

[0018] According to some specific embodiments of the present invention, in the special medical purpose formula food of the present invention, α-lactalbumin accounts for 8%-60% of the total protein content of the food.

[0019] According to some specific embodiments of the present invention, in the special medical purpose formula food of the present invention, α-lactalbumin accounts for 8%-30% of the total protein content of the food.

[0020] According to some specific embodiments of the present invention, in the special medical purpose formula food of the present invention, α-lactalbumin accounts for 8%-22% of the total protein content of the food.

[0021] According to some specific embodiments of the present invention, in the special medical purpose formula food of the present invention, α-lactalbumin accounts for 8%-21% of the total protein content of the food.

[0022] According to some specific embodiments of the present invention, in the special medical purpose formula food of the present invention, α-lactalbumin accounts for 10%-21% of the total protein content of the food.

[0023] According to some specific embodiments of the present invention, the α-lactalbumin content in the special medical purpose formula food of the present invention is 1.0-2.5g / 100g dry matter, preferably 1.5-2.3g / 100g dry matter.

[0024] According to a specific embodiment of the present invention, in the special medical purpose formula food of the present invention, the linoleic acid can be obtained from conventionally commercially available sources. For example, it can be provided by conventionally commercially available mono- and diglyceride fatty acid esters.

[0025] According to a specific embodiment of the present invention, in the special medical purpose formula food of the present invention, linoleic acid accounts for 10%-50% of the total fat content of the food, preferably 10%-20%.

[0026] According to a specific embodiment of the present invention, the total fat content in the special medical purpose formula food of the present invention can be 10g-35g / 100g of dry matter. For special medical purpose infant formula food, the total fat content is preferably 1.05g-1.40g / 100kJ.

[0027] According to some specific embodiments of the present invention, the linoleic acid content in the special medical purpose formula foods of the present invention, converted to dry matter, is 2700-6000 mg / 100g. For special medical purpose infant formula foods, the linoleic acid content is 0.07-0.33 g / 100kJ.

[0028] According to some specific embodiments of the present invention, in the special medical purpose formula food of the present invention, the prebiotic can be selected from oligosaccharides with a degree of polymerization of 3-10.

[0029] According to a specific embodiment of the present invention, the prebiotic in the special medical purpose formulation food of the present invention comprises one or more of the following: galacto-oligosaccharides (GOS), fructo-oligosaccharides (FOS), fucosyllactose (e.g., 2'-fucosyllactose, 2'-FL, or 2-F), and neutral oligosaccharides without fucoyl or sialic acid groups. The neutral oligosaccharides may, for example, include one or more of lactose-N-neotetraose (LNnT) or lactose-N-tetraose (LNT). Preferably, the prebiotic is selected from one or a combination of two of GOS, FOS, 2'-FL, and LNnT. Conventional food-grade prebiotics are sufficient.

[0030] In some specific embodiments of the present invention, the prebiotic in the special medical purpose formula food of the present invention is GOS.

[0031] In some specific embodiments of the present invention, the prebiotic in the special medical purpose formula food of the present invention is FOS.

[0032] In some specific embodiments of the present invention, the prebiotic in the special medical purpose formula food of the present invention is a composition comprising GOS and FOS, which can be compounded in a mass ratio of (1-10):(10-1). Preferably, GOS and FOS can be compounded in a mass ratio of (0.5-10):1.

[0033] In some specific embodiments of the present invention, in the special medical purpose formula food of the present invention, the prebiotic is a composition comprising 2'-FL and LNnT, which can be compounded in a mass ratio of (1-10):(10-1). Preferably, 2'-FL and LNnT can be compounded in a mass ratio of (1-10):1, more preferably in a mass ratio of (2-5):1.

[0034] According to some specific embodiments of the present invention, the prebiotic content in the special medical purpose formula food of the present invention is 0.5g-4.8g / 100g of dry matter.

[0035] According to some specific embodiments of the present invention, the prebiotic content in the special medical purpose formula food of the present invention is 0.5g-3g / 100g of dry matter.

[0036] According to some specific embodiments of the present invention, the prebiotic content in the special medical purpose formula food of the present invention is 0.8g-3g / 100g of dry matter.

[0037] According to some specific embodiments of the present invention, the prebiotic content in the special medical purpose formula food of the present invention is 2g-3g / 100g of dry matter.

[0038] According to some specific embodiments of the present invention, in the special medical purpose formula food of the present invention, the mass ratio of α-lactalbumin, linoleic acid and prebiotics is (0.30-0.60):1:(0.12-0.96).

[0039] According to some specific embodiments of the present invention, in the special medical purpose formula food of the present invention, the mass ratio of α-lactalbumin, linoleic acid and prebiotics is (0.30-0.55):1:(0.15-0.96).

[0040] According to some specific embodiments of the present invention, in the special medical purpose formula food of the present invention, the mass ratio of α-lactalbumin, linoleic acid and prebiotics is (0.30-0.55):1:(0.15-0.8).

[0041] According to some specific embodiments of the present invention, in the special medical purpose formula food of the present invention, the mass ratio of α-lactalbumin, linoleic acid and prebiotics is (0.32-0.55):1:(0.15-0.7).

[0042] According to some specific embodiments of the present invention, in the special medical purpose formula food of the present invention, the mass ratio of α-lactalbumin, linoleic acid and prebiotics is (0.40-0.55):1:(0.15-0.7).

[0043] According to some specific embodiments of the present invention, in the special medical purpose formula food of the present invention, the mass ratio of α-lactalbumin, linoleic acid and prebiotics is (0.32-0.55):1:(0.25-0.7).

[0044] According to some specific embodiments of the present invention, in the special medical purpose formula food of the present invention, the mass ratio of α-lactalbumin, linoleic acid and prebiotics is (0.30-0.55):1:(0.38-0.7).

[0045] According to some specific embodiments of the present invention, in the special medical purpose formula food of the present invention, the mass ratio of α-lactalbumin, linoleic acid and prebiotics is (0.40-0.55):1:(0.42-0.70).

[0046] According to some specific embodiments of the present invention, in the special medical purpose formula food of the present invention, the mass ratio of α-lactalbumin, linoleic acid and prebiotics is (0.40-0.55):1:(0.50-0.70).

[0047] According to some specific embodiments of the present invention, in the special medical purpose formula food of the present invention, the mass ratio of α-lactalbumin, linoleic acid and prebiotics is (0.50-0.55):1:(0.60-0.68).

[0048] In some specific embodiments of the present invention, the special medical purpose formula food of the present invention can be prepared by adding / adjusting α-lactalbumin, linoleic acid, and prebiotics to a general special medical purpose formula food. After preparing the special medical purpose formula food of the present invention, the content of α-lactalbumin, linoleic acid, and prebiotics can be determined using methods specified in relevant standards or conventional methods in the field, such as high-performance liquid chromatography (HPLC) analysis.

[0049] According to a specific embodiment of the present invention, the raw materials providing total protein in the special medical purpose formula foods of the present invention may include one or more of the following: raw milk (cow / sheep), whole milk powder (cow / sheep), skim milk powder (cow / sheep), whey protein powder (cow / sheep), demineralized whey powder (cow / sheep), β-casein powder, etc. Specifically, based on 1000 parts by weight of the special medical purpose formula food of the present invention, the raw materials include: 0-7000 parts of raw milk (cow / sheep), 0-260 parts of whole milk powder (cow / sheep), 0-120 parts of whey protein powder (cow / sheep), 0-500 parts of skim milk powder (cow / sheep), and / or 0-600 parts of demineralized whey powder (cow / sheep), with an addition amount of 0-40 parts of β-casein powder. For special medical purpose infant formula foods, the protein therein may be partially hydrolyzed or extensively hydrolyzed.

[0050] According to a specific embodiment of the present invention, in the special medical purpose formula food of the present invention, the raw materials providing fat, in addition to the basic raw material containing milk fat, also include vegetable oils. The vegetable oils may include, but are not limited to, one or more of edible vegetable blended oils, sunflower seed oil, corn oil, soybean oil, low-erucic acid rapeseed oil, coconut oil, palm oil, and walnut oil, preferably including sunflower seed oil, corn oil, and soybean oil. The addition of these vegetable oils provides the product with fat components and linoleic acid, and may also provide α-linolenic acid. For special medical purpose infant formula foods, the amounts of linoleic acid and α-linolenic acid should meet the relevant standard requirements.

[0051] According to specific embodiments of the present invention, the carbohydrate content in the special medical purpose formula food of the present invention is 40-70g / 100g. For special medical purpose infant formula food, the amount of carbohydrates should be 2.2g-3.3g / 100kJ. The carbohydrates in the special medical purpose formula food of the present invention may be derived from lactose or non-lactose sources, including but not limited to pregelatinized starch, maltodextrin, solid corn syrup, glucose syrup, and some may be derived from modified starch emulsifiers. In some specific embodiments of the present invention, the special medical purpose formula food of the present invention is a special medical purpose formula for premature / low birth weight infants.

[0052] According to a specific embodiment of the present invention, the special medical purpose formula food of the present invention further includes, but is not limited to, appropriate amounts of one or more of DHA, ARA, EPA, nucleotides, lactoferrin, calcium powder, vitamins, and minerals. The specific amounts of these substances should be determined by routine adjustments based on the specific product category, provided that the relevant standard requirements are met.

[0053] In the special medical purpose formula food of the present invention, all raw materials are commercially available, and the selection of each raw material should meet the relevant standard requirements.

[0054] According to a preferred embodiment of the present invention, the special medical purpose formula food of the present invention is a special medical purpose formula food for premature / low birth weight infants, the raw materials of which include (based on 1000 parts by weight of product dry matter):

[0055] Hydrolyzed whey protein powder 0-200 parts by weight, whey protein powder 0-50 parts by weight, demineralized whey powder 100-500 parts by weight, casein 0-100 parts by weight; phospholipids 0-10 parts by weight, anhydrous butter 0-50 parts by weight, solid corn syrup 0-400 parts by weight, maltodextrin 0-400 parts by weight, sunflower seed oil 0-150 parts by weight, corn oil 0-40 parts by weight, soybean oil 20-80 parts by weight, medium-chain triglycerides 0-100 parts by weight, tryptophan 0-10 parts by weight The formula contains: 0-10 parts by weight of arginine, 1-5 parts by weight of compound vitamins, 0-3 parts by weight of magnesium chloride, 0-3 parts by weight of choline chloride, 0-2 parts by weight of mineral I, 1-12 parts by weight of mineral II, 0-15 parts by weight of mineral III, 0-15 parts by weight of DHA, 0-20 parts by weight of ARA, 0-1.5 parts by weight of nucleotides, and 0-2 parts by weight of lactoferrin. Mineral I includes elements such as copper, iron, and iodine; mineral II includes elements such as sodium and potassium; and mineral III includes elements such as calcium and phosphorus.

[0056] According to some preferred embodiments of the present invention, the special medical purpose premature / low birth weight infant formula of the present invention may optionally include one or more of the following ingredients (based on 1000 parts by weight of product dry matter): 0.20 to 2.04 parts by weight of inositol, 0 to 0.65 parts by weight of taurine, 0.06 to 0.5 parts by weight of L-carnitine, 3 to 18 parts by weight of DHA, and 3 to 18 parts by weight of ARA.

[0057] According to a specific embodiment of the present invention, in the special medical purpose formula food of the present invention, various vitamins and minerals can be composed of compound nutrient compositions that meet national standards, and different addition amounts are used according to different formulas. The specific addition method can be carried out with reference to conventional operations in the relevant field. Preferably, if compound nutrients are added as needed, the special medical purpose formula food of the present invention can selectively use any or any combination of the following compound nutrient components (content per gram; the amount of each indicator calculated according to the median value of the addition range; there is basically no situation where the content of all indicators is at its maximum at the same time):

[0058] Vitamin A: 1300–4000 μgRE

[0059] Vitamin D: 24–60 μg

[0060] Vitamin E: 13-41 mg α-TE

[0061] Vitamin K1: 200–550 μg

[0062] Vitamin B1: 1500–6500 μg

[0063] Vitamin B2: 600–3000 μg

[0064] Vitamin B6: 1000–4000 μg

[0065] Vitamin B 12 2~12μg

[0066] Nicotinamide: 12000~30000μg

[0067] Folic acid: 300–653 μg

[0068] Pantothenic acid: 8750~16230μg

[0069] Biotin: 56–150 μg

[0070] Sodium: 30–350 mg

[0071] Potassium: 63-400mg

[0072] Copper: 2200~5540μg

[0073] Magnesium: 50–400 mg

[0074] Iron: 23-95mg

[0075] Zinc: 25-52 mg

[0076] Calcium: 110–300 mg

[0077] Phosphorus: 75–200 mg

[0078] Iodine: 200–1592 μg.

[0079] In some specific embodiments of the present invention, the special medical purpose formula food of the present invention can be prepared by the following method: using a wet method, a dry method, or a combined wet and dry production process, α-lactalbumin, linoleic acid, and prebiotics are mixed with other raw materials in the formula to prepare the special medical purpose formula food. In some more specific embodiments, the preparation process of the special medical purpose formula food mainly includes: ingredient mixing, homogenization, concentration and sterilization, spray drying, and dry mixing to obtain the finished product.

[0080] On the other hand, the present invention also provides the application of a composition comprising α-lactalbumin, linoleic acid and prebiotics in the preparation of a special medical purpose food with improved bioavailability of stable amino acids, wherein the special medical purpose food is any of the special medical purpose foods described above in the present invention.

[0081] According to a specific embodiment of the present invention, the stable amino acid includes one or more of glycine, alanine, valine, leucine, isoleucine, proline, serine, aspartic acid, glutamic acid, threonine, arginine, lysine, and histidine; preferably, it includes one or more of valine, leucine, isoleucine, proline, threonine, lysine, and histidine; more preferably, it includes one or more of valine, leucine, isoleucine, threonine, lysine, and histidine.

[0082] According to a specific embodiment of the present invention, improving the bioavailability of stable amino acids includes increasing the digestibility and / or absorption of one or more of glycine, alanine, valine, leucine, isoleucine, proline, serine, aspartic acid, glutamic acid, threonine, arginine, lysine, and histidine. Preferably, improving the bioavailability of stable amino acids includes increasing the digestibility and / or absorption of one or more of valine, leucine, isoleucine, proline, threonine, lysine, and histidine. More preferably, improving the bioavailability of stable amino acids includes increasing the digestibility and / or absorption of any one of valine, leucine, isoleucine, threonine, lysine, and histidine, or increasing the overall digestibility and / or absorption of these amino acids.

[0083] On the other hand, the present invention also provides a method for improving the bioavailability of stable amino acids in protein-containing foods for special medical purposes, wherein the food is any of the aforementioned foods for special medical purposes of the present invention, and the method includes:

[0084] The content of α-lactalbumin, linoleic acid, and prebiotics in foods for special medical purposes is controlled such that the mass ratio of α-lactalbumin, linoleic acid, and prebiotics is (0.25-0.6):1:(0.1-0.96). Preferably, the mass ratio of α-lactalbumin, linoleic acid, and prebiotics is controlled within the more specific range of the present invention described above.

[0085] In some specific embodiments of the present invention, the mass ratio of α-lactalbumin, linoleic acid and prebiotics in special medical purpose formula foods is controlled to be (0.30-0.60):1:(0.12-0.96).

[0086] In some specific embodiments of the present invention, the mass ratio of α-lactalbumin, linoleic acid and prebiotics in special medical purpose formula foods is controlled to be (0.30-0.55):1:(0.15-0.96).

[0087] In some specific embodiments of the present invention, the mass ratio of α-lactalbumin, linoleic acid and prebiotics in special medical purpose formula foods is controlled to be (0.30-0.55):1:(0.15-0.8).

[0088] In some specific embodiments of the present invention, the mass ratio of α-lactalbumin, linoleic acid and prebiotics in special medical purpose formula foods is controlled to be (0.32-0.55):1:(0.15-0.7).

[0089] In some specific embodiments of the present invention, the mass ratio of α-lactalbumin, linoleic acid and prebiotics in special medical purpose formula foods is controlled to be (0.40-0.55):1:(0.15-0.7).

[0090] In some specific embodiments of the present invention, the mass ratio of α-lactalbumin, linoleic acid and prebiotics in special medical purpose formula foods is controlled to be (0.32-0.55):1:(0.25-0.7).

[0091] In some specific embodiments of the present invention, the mass ratio of α-lactalbumin, linoleic acid and prebiotics in special medical purpose formula foods is controlled to be (0.30-0.55):1:(0.38-0.7).

[0092] In some specific embodiments of the present invention, the mass ratio of α-lactalbumin, linoleic acid and prebiotics in special medical purpose formula foods is controlled to be (0.40-0.55):1:(0.42-0.70).

[0093] In some specific embodiments of the present invention, the mass ratio of α-lactalbumin, linoleic acid and prebiotics in special medical purpose formula foods is controlled to be (0.40-0.55):1:(0.50-0.70).

[0094] In some specific embodiments of the present invention, the mass ratio of α-lactalbumin, linoleic acid and prebiotics in special medical purpose formula foods is controlled to be (0.50-0.55):1:(0.60-0.68).

[0095] In some specific embodiments of the present invention, the effect of a combination of α-lactalbumin, linoleic acid, and prebiotics on the digestibility and bioavailability of stable amino acids was investigated in a piglet model experiment. First, changes in piglet weight were tracked to confirm that the tested formula had no effect on piglet growth and development. Then, the amino acid composition of the tested groups was measured; the four groups showed essentially no significant differences except for a few amino acids. A 10-day feeding experiment was then conducted, and digesta samples from the terminal ileum were collected afterward to avoid the influence of intestinal microorganisms on the measurements. After analyzing the amino acid composition of the digesta samples, apparent and standard digestibility were calculated, verifying that the combination of α-lactalbumin, linoleic acid, and prebiotics can improve the digestibility and absorption of acid-stable amino acids such as valine, leucine, isoleucine, threonine, lysine, and histidine.

[0096] The special medical purpose formulation food of the present invention, containing α-lactalbumin, linoleic acid and prebiotics, can improve the bioavailability of protein, especially the digestibility and / or absorption of stable amino acids. Attached Figure Description

[0097] Figure 1 This shows the changes in body weight of experimental animals in different groups in a specific embodiment of the present invention.

[0098] Figure 2 This shows the total amount of acid-stable amino acids measured in different groups of experimental animals in specific embodiments of the present invention.

[0099] Figure 3 This shows the determination of acid-stable essential amino acids in different groups of experimental animals in specific embodiments of the present invention.

[0100] Figure 4 This shows the determination of acid-stable non-essential amino acids in different groups of experimental animals in specific embodiments of the present invention.

[0101] Figure 5 This shows the apparent digestibility of proteins in different groups of experimental animals in specific embodiments of the present invention.

[0102] Figure 6 This figure shows the apparent digestibility of acid-stable essential amino acids in different groups of experimental animals in specific embodiments of the present invention. In the figure, the same letter indicates no statistically significant difference between the two groups, while no identical letters indicate a significant difference between the groups.

[0103] Figure 7 This figure shows the apparent digestibility of acid-stable non-essential amino acids in different groups of experimental animals in specific embodiments of the present invention. In the figure, the same letter indicates no statistically significant difference between the two groups, while no identical letters indicate a significant difference between the groups.

[0104] Figure 8 This figure shows the apparent digestibility of acid-stable essential amino acids (combined) in different groups of experimental animals in specific embodiments of the present invention. In the figure, the same letter indicates no statistically significant difference between the two groups, while no identical letters indicate a significant difference between the groups.

[0105] Figure 9 This figure shows the apparent digestibility of acid-stable non-essential amino acids (combined) in different groups of experimental animals in specific embodiments of the present invention. In the figure, groups marked with the same letter indicate no statistically significant difference between groups, while groups marked with different letters indicate a significant difference between groups.

[0106] Figure 10 This figure shows the standard digestibility of acid-stable essential amino acids in different groups of experimental animals in specific embodiments of the present invention. In the figure, the same letter indicates no statistically significant difference between the two groups, while no identical letters indicate a significant difference between the groups. Detailed Implementation

[0107] Before further describing specific embodiments of the present invention, it should be understood that the scope of protection of the present invention is not limited to the specific embodiments described below; it should also be understood that the terminology used in the embodiments of the present invention is for describing specific embodiments and not for limiting the scope of protection of the present invention.

[0108] When numerical ranges are given in the embodiments, it should be understood that, unless otherwise stated in the present invention, the two endpoints of each numerical range and any value between the two endpoints may be selected.

[0109] Unless otherwise defined, all technical and scientific terms used in this invention have the same meaning as commonly understood by one of ordinary skill in the art.

[0110] In addition to the specific methods, equipment, and materials used in the embodiments, based on the knowledge of those skilled in the art and the description of this invention, any prior art methods, equipment, and materials similar to or equivalent to those described, equipment, and materials in the embodiments of this invention can be used to implement this invention.

[0111] Unless otherwise stated, the experimental methods, detection methods and preparation methods disclosed in this invention all adopt conventional techniques in this technical field.

[0112] Example 1: Tofeel Early Care Special Medical Purpose Premature / Low Birth Weight Infant Formula

[0113] Ingredients: 310 parts by weight of maltodextrin, 240 parts by weight of blended edible vegetable oil, 200 parts by weight of demineralized whey powder, 90 parts by weight of hydrolyzed whey protein powder, 85 parts by weight of skim milk powder, 20 parts by weight of whey protein powder (α-lactalbumin powder), 10 parts by weight of casein, 4 parts by weight of phospholipids, 3.0 parts by weight of magnesium chloride, 6.0 parts by weight of compound vitamins, 1.0 part by weight of choline chloride, 2.0 parts by weight of mineral I, 17.0 parts by weight of mineral II, 19.0 parts by weight of mineral III, 8.7 parts by weight of DHA, 15.0 parts by weight of ARA, and 0.3 parts by weight of nucleotides. Among them, mineral I includes elements such as copper, iron, and iodine; mineral II includes elements such as sodium and potassium; and mineral III includes elements such as calcium and phosphorus. The mass ratio of α-lactalbumin:linoleic acid:prebiotics in the ingredients can be adjusted to within the range of (0.40-0.55):1:(0.15-0.7) depending on the specific product.

[0114] Example 2: Tofeel Early Care Special Medical Purpose Premature / Low Birth Weight Infant Formula

[0115] Ingredients: 305 parts by weight of solid corn syrup, 216 parts by weight of blended edible vegetable oil, 200 parts by weight of demineralized whey powder, 100 parts by weight of skim milk powder, 55 parts by weight of hydrolyzed whey protein powder, 38 parts by weight of anhydrous butter, 30 parts by weight of whey protein powder (α-lactalbumin powder), 20 parts by weight of casein, 4 parts by weight of phospholipids, 2.6 parts by weight of magnesium chloride, 4.0 parts by weight of compound vitamins, 1.0 part by weight of choline chloride, and 1.5 parts by weight of minerals. The ingredients include: 15.5 parts by weight of mineral II, 15.5 parts by weight of mineral III, 8.7 parts by weight of DHA, 15.0 parts by weight of ARA, and 0.3 parts by weight of nucleotides. Among them, mineral I includes elements such as copper, iron, and iodine; mineral II includes elements such as sodium and potassium; and mineral III includes elements such as calcium and phosphorus. The mass ratio of α-lactalbumin:linoleic acid:prebiotics in the raw materials can be adjusted to within the range of (0.32-0.55):1:(0.15-0.7) depending on the specific product.

[0116] Example 3: Tofeel Early Care Special Medical Purpose Premature / Low Birth Weight Infant Formula

[0117] Ingredients: 310 parts by weight of maltodextrin, 240 parts by weight of blended edible vegetable oil, 200 parts by weight of demineralized whey powder, 90 parts by weight of hydrolyzed whey protein powder, 85 parts by weight of skim milk powder, 20 parts by weight of whey protein powder (α-lactalbumin powder), 10 parts by weight of casein, 4 parts by weight of phospholipids, 3.0 parts by weight of magnesium chloride, 6.0 parts by weight of compound vitamins, 1.0 part by weight of choline chloride, 2.0 parts by weight of mineral I, 17.0 parts by weight of mineral II, 19.0 parts by weight of mineral III, 8.7 parts by weight of DHA, 15.0 parts by weight of ARA, and 0.3 parts by weight of nucleotides. Among them, mineral I includes elements such as copper, iron, and iodine; mineral II includes elements such as sodium and potassium; and mineral III includes elements such as calcium and phosphorus. The mass ratio of α-lactalbumin:linoleic acid:prebiotics in the ingredients can be adjusted to within the range of (0.3-0.6):1:(0.1-0.96) depending on the specific product.

[0118] Example 4: Tofeel Early Care Special Medical Purpose Premature / Low Birth Weight Infant Formula

[0119] Ingredients: 305 parts by weight of solid corn syrup, 216 parts by weight of blended edible vegetable oil, 200 parts by weight of demineralized whey powder, 100 parts by weight of skim milk powder, 55 parts by weight of hydrolyzed whey protein powder, 38 parts by weight of anhydrous butter, 30 parts by weight of whey protein powder (α-lactalbumin powder), 20 parts by weight of casein, 4 parts by weight of phospholipids, 2.6 parts by weight of magnesium chloride, 4.0 parts by weight of compound vitamins, 1.0 part by weight of choline chloride, and 1.5 parts by weight of minerals. The ingredients include: 15.5 parts by weight of mineral II, 15.5 parts by weight of mineral III, 8.7 parts by weight of DHA, 15.0 parts by weight of ARA, and 0.3 parts by weight of nucleotides. Among them, mineral I includes elements such as copper, iron, and iodine; mineral II includes elements such as sodium and potassium; and mineral III includes elements such as calcium and phosphorus. The mass ratio of α-lactalbumin:linoleic acid:prebiotics in the raw materials can be adjusted to within the range of (0.25-0.6):1:(0.1-0.96) depending on the specific product.

[0120] The formulated food products in each embodiment were prepared using conventional methods in their respective fields. Testing showed that all indicators of the finished products met the relevant standard requirements.

[0121] Experimental study on the efficacy of foods containing α-lactalbumin, linoleic acid, and prebiotics in improving the bioavailability of stable amino acids.

[0122] In the following efficacy experiments, the α-lactalbumin used was derived from whey protein powder of bovine milk, with an α-lactalbumin content ≥40%. Linoleic acid was obtained from commercially available mono- and diglyceride fatty acid esters. All prebiotics used were commercially available, with oligosaccharide polymerization degrees of 3-10. Among them, galacto-oligosaccharides (GOS) were produced from lactose through fermentation with Bacillus or Aspergillus oryzae, with a content of not less than 57%. Fructo-oligosaccharides (FOS) were prepared from chicory (or Jerusalem artichoke) through enzymatic hydrolysis or membrane separation processes; or from sucrose through fermentation with Aspergillus niger or Aspergillus oryzae, with a content of not less than 93%. 2'-Fucosyllactose (2'-FL or 2-FL) is a trisaccharide formed from fucose and lactose through microbial fermentation. It is a representative substance of fucosyl oligosaccharides, with a content of not less than 94%. Lacto-N-neotetraose (LNnT) is a tetrasaccharide obtained from lactose and other raw materials through microbial fermentation, purification, and drying processes. It is a representative substance of neutral oligosaccharides, with a content of not less than 92%. Lacto-N-tetraose (LNT) is another tetrasaccharide obtained from lactose and other raw materials through microbial fermentation, purification, and drying processes. It is another representative substance of neutral oligosaccharides, with a content of not less than 90%.

[0123] Eleven-day-old piglets with an initial weight of 3.20-3.50 kg were selected for the experiment. Based on the principle of similar average weight, the piglets were randomly divided into four groups of six piglets each. Each group was fed a formula for 10 days at a rate of 42 g dry matter / kg. Feed intake, weight gain, and the occurrence of adverse reactions such as diarrhea were observed. On the tenth day of the experiment, the piglets were euthanized, and samples of digesta from the terminal ileum were collected.

[0124] The piglets were placed individually in special feeding boxes with the temperature controlled at 26-28℃ and the relative humidity controlled at 40-70%, with artificial lighting and alternating light and dark for 12 hours.

[0125] In addition to the four test groups, a nitrogen-free diet group was set up, consisting of five 11-day-old piglets with an initial weight of 3.2-3.5 kg. The nitrogen-free diet group (mainly composed of carbohydrates and minerals, without protein components, linoleic acid, or prebiotics) was set up to determine the basic endogenous loss of protein and amino acids, so as to calculate the standard digestibility of each amino acid in different groups later.

[0126] The food fed to each group was a base powder formulated with reference to infant formula, with adjustments made to the content of α-lactalbumin, linoleic acid and prebiotics. The specific composition of the formula is shown in Table 1.

[0127] Table 1

[0128]

[0129] Note:

[0130] 1. Vitamins and minerals are added in accordance with regulations, and the content is consistent across all food groups.

[0131] 2. Groups 4 and 5 have the same prebiotic content, but different types. Groups 1-4 use a 1:1 mass ratio of GOS and FOS prebiotics, while Group 5 uses a 4:1 mass ratio of 2'-FL and LNnT prebiotics.

[0132] Stable amino acid detection:

[0133] Stable amino acids refer to those detectable after high-temperature hydrolysis in 6 mol / L hydrochloric acid solution for 22 hours according to GB / T 5009.124-2016 "Determination of Amino Acids in Food". These include glycine, alanine, valine, leucine, isoleucine, proline, serine, aspartic acid, glutamic acid, threonine, arginine, lysine, and histidine. Amino acids in each group and collected chyme samples were detected according to GB / T 5009.124, and the apparent digestibility and ileal standard digestibility of different amino acids in different groups were calculated.

[0134] Data processing and statistical analysis:

[0135] Apparent protein digestibility (%) of the feed = [(total protein intake - ileal chyme protein intake) / total protein intake] × 100;

[0136] Apparent amino acid digestibility (%) of fed food = [(Amount of ingested amino acids - Amount of the same amino acid in ileal chyme) / Amount of ingested amino acids] × 100;

[0137] The standard digestibility (%) of amino acids in the feed is calculated as follows: [(Amount of ingested amino acids - Amount of the same amino acid in the ileal digesta + Amount of the same amino acid in the ileum) / Amount of ingested amino acids] × 100.

[0138] It can be seen that the protein digestibility measured in this invention refers to the ratio of the protein in the ingested food that can be absorbed and utilized by the digestive tract of an organism (including peptides and amino acids produced after digestion) to the total amount of protein ingested. The amino acid digestibility measured in this invention refers to the proportion of amino acids in the ingested food (including amino acids contained in proteins and peptides, as well as free amino acids) that can be absorbed and utilized by the digestive tract of an organism. Therefore, the protein / amino acid digestibility measured in this invention can be considered to essentially refer to the bioavailability of protein / amino acids.

[0139] Experimental results:

[0140] 1) Weight changes of piglets in each group

[0141] From day 1 (D1) to day 9 (D9), the weight of piglets was recorded at fixed times every 3 days to track changes in their weight. The results are as follows: Figure 1 As shown in the figure, there were no significant differences in the weight changes of piglets in each group, and no adverse phenomena such as loss of appetite, bloating or diarrhea were observed in piglets during the 10-day feeding period, indicating that the tested formula can meet the normal growth needs of piglets.

[0142] 2) Determination of amino acid composition in each formulation

[0143] Before feeding piglets, the composition of acid-stable amino acids in each group of formulas was determined to clarify the amino acid composition of the formulas before digestion.

[0144] The acid stability and amino acid content of each group are as follows: Figure 2 As shown, there was no significant difference in the total amino acid content calculated in groups 1-5.

[0145] According to essential amino acids ( Figure 3 ) and non-essential amino acids ( Figure 4 Grouping and analysis were performed, and then the essential amino acids were grouped according to branched-chain amino acids ( Figure 3 Image A) and non-branched amino acids ( Figure 3 Image B) was further analyzed by grouping. The results showed that group 4 had lower levels of threonine, lysine, and proline than groups 1-3, but histidine did not show a significant difference. Although the levels of branched-chain fatty acids were not completely identical across the four groups, no statistically significant differences were found. Among non-essential amino acids, group 4 had lower levels of serine than the other three groups. For the remaining amino acids, although some types of amino acids had higher levels in group 4 than in the other three groups, the differences were not statistically significant.

[0146] 3) Apparent digestibility of amino acids in each group

[0147] After 10 days of feeding each group of piglets with their respective formulas, ileal digesta samples were collected, freeze-dried, ground, and the protein and amino acid content in each group's digesta samples was determined. The apparent digestibility of protein and the apparent digestibility of different amino acids in each group were calculated.

[0148] Figure 5 The apparent digestibility of proteins in each group was calculated, and the results showed that the digestibility of proteins in each group was approximately 80%, with no statistically significant difference.

[0149] Figure 6 The apparent digestibility of acid-stable essential amino acids in each group was displayed. Results showed significant differences in the digestibility of different amino acids across different groups. Specifically, the apparent digestibility of threonine, lysine, and branched-chain amino acids (valine, isoleucine, and leucine) was significantly higher in groups 1, 4, and 5 than in groups 2 and 3. Branched-chain amino acids promote protein synthesis and have anti-degradation effects, supporting infant growth and development. Clinical RCT studies have also shown a positive correlation between serum branched-chain amino acid levels and children's height-age Z-score. Furthermore, histidine, an essential amino acid for infants, showed significantly higher absorption and utilization rates in groups 4 and 5 compared to the other three groups.

[0150] Figure 7 The apparent digestibility of acid-stable non-essential amino acids in each group is shown. Analysis of the apparent digestibility of acid-stable non-essential amino acids revealed significant differences in digestibility among different groups. Specifically, the apparent digestibility of aspartic acid and glutamic acid in groups 1, 4, and 5 was significantly higher than that in groups 2 and 3.

[0151] Figure 8 The apparent digestibility of acid-stable essential amino acids (combined) in different groups showed a similar trend to that of individual amino acids. The apparent digestibility of groups 4, 5, and 1 was higher than that of groups 2 and 3, and the differences were statistically significant.

[0152] Figure 9 The apparent digestibility of acid-stable non-essential amino acids (combined) in different groups showed a similar trend to that of individual amino acids. The apparent digestibility of groups 4, 5, and 1 was higher than that of groups 2 and 3, and the differences were statistically significant.

[0153] 4) Standard digestibility of essential amino acids in each group

[0154] The apparent digestibility of different amino acids in each group was calculated. Combined with the basal endogenous loss of amino acids measured in the nitrogen-free diet group, the standard digestibility of acid-stable essential amino acids in different groups was calculated.

[0155] Standard digestibility of acid-stable essential amino acids in each group as follows: Figure 10As shown, the trends of standard digestibility and apparent digestibility are generally consistent. The standard digestibility of amino acids in groups 1, 4, and 5, including threonine, lysine, and branched-chain amino acids (valine, isoleucine, and leucine), is significantly higher than that in groups 2 and 3.

[0156] The above experiments demonstrate that by controlling the ratio of α-lactalbumin, linoleic acid, and prebiotics in foods for special medical purposes, this invention can effectively improve the bioavailability of stable amino acids in the food, particularly promoting the absorption and utilization of threonine, lysine, and branched-chain amino acids (valine, isoleucine, and leucine). Therefore, the food for special medical purposes containing α-lactalbumin, linoleic acid, and prebiotics provided by this invention can improve protein quality and enhance the bioavailability of stable amino acids.

[0157] The above description of the embodiments is provided to enable those skilled in the art to understand and use the invention. It will be apparent to those skilled in the art that various modifications can be made to these embodiments, and the general principles described herein can be applied to other embodiments without inventive effort. Therefore, the present invention is not limited to the above embodiments, and any improvements and modifications made by those skilled in the art based on the disclosure of the present invention without departing from the scope of the invention should be within the protection scope of the present invention.

Claims

1. A special medical purpose formula comprising alpha-lactalbumin, linoleic acid and prebiotics, the mass ratio of alpha-lactalbumin, linoleic acid and prebiotics being (0.25-0.6):1:(0.1-0.96).

2. The special medical purpose formula according to claim 1, which is a special medical purpose infant formula for infants from 0 to 12 months or a special medical purpose formula for people over 1 year old. Preferably, the special medical purpose formula is a special medical purpose preterm / low birth weight infant formula.

3. The special medical food for use according to claim 1, wherein, The mass ratio of alpha-lactalbumin, linoleic acid and prebiotics is (0.30-0.60):1:(0.12-0.96); Preferably, the mass ratio of alpha-lactalbumin, linoleic acid and prebiotics is (0.30-0.55):1:(0.15-0.96), Further preferably (0.30-0.55):1:(0.15-0.8), Further preferably (0.32-0.55):1:(0.15-0.7), Further preferably (0.40-0.55):1:(0.15-0.7) or (0.32-0.55):1:(0.25-0.7).

4. The special medical purposes formula of any one of claims 1-3, wherein, The alpha-lactalbumin accounts for 8%-100% of the total protein content in the special medical purpose formula; preferably 8%-30%; more preferably 10%-21%; The linoleic acid accounts for 10%-50% of the total fat content in the special medical purpose formula, preferably 10%-20%; The prebiotics content is 0.5g-4.8g / 100g of food dry matter, preferably 0.5g-3g / 100g of food dry matter.

5. The special medical purposes formula of any one of claims 1-4, wherein, The prebiotics include one or more of oligogalactose, oligofructose, fucosyllactose, neutral oligosaccharides without fucosyl or sialyl groups.

6. The special medical purposes formula of any one of claims 1-4, wherein, The prebiotics are selected from one or a combination of more than two of GOS, FOS, 2'-FL and LNnT.

7. The special medical purpose formula according to any one of claims 1-6, which is a special medical purpose preterm / low birth weight infant formula, the raw materials of which include, based on 1000 parts by weight of product dry matter: Hydrolyzed whey protein powder 0-200 parts by weight, whey protein powder 0-50 parts by weight, desalted whey powder 100-500 parts by weight, casein 0-100 parts by weight; phospholipid 0-10 parts by weight, anhydrous butter 0-50 parts by weight, solid corn syrup 0-400 parts by weight, malt dextrin 0-400 parts by weight, sunflower oil 0-150 parts by weight, corn oil 0-40 parts by weight, soybean oil 20-80 parts by weight, medium-chain triglyceride 0-100 parts by weight, tryptophan 0-10 parts by weight, arginine 0-10 parts by weight, compound vitamin 1-5 parts by weight, magnesium chloride 0-3 parts by weight, choline chloride 0-3 parts by weight, mineral 1 0-2 parts by weight, mineral 2 1-12 parts by weight, mineral 3 0-15 parts by weight, DHA 0-15 parts by weight, ARA 0-20 parts by weight, nucleotide 0-1.5 parts by weight, lactoferrin 0-2 parts by weight; mineral 1 includes copper, iron, iodine and other elements, mineral 2 includes sodium, potassium and other elements, and mineral 3 includes calcium, phosphorus and other elements.

8. Use of a composition comprising alpha-lactalbumin, linoleic acid and a prebiotic for the manufacture of a special medical purpose formula for improving the bioavailability of stable amino acids, wherein, The special medical purpose formula food is the special medical purpose formula food of any one of claims 1-7.

9. Use according to claim 8, wherein, The improvement of the bioavailability of the stable amino acids includes increasing the digestibility and / or absorption utilization rate of one or more of glycine, alanine, valine, leucine, isoleucine, proline, serine, aspartic acid, glutamic acid, threonine, arginine, lysine and histidine. Preferably, the improvement of the bioavailability of the stable amino acids includes increasing the digestibility and / or absorption utilization rate of one or more of valine, leucine, isoleucine, proline, threonine, lysine and histidine.

10. A method of improving the bioavailability of stable amino acids in a protein- containing special medical purpose formula, wherein, The special medical purpose formula food is the special medical purpose formula food of any one of claims 1-7, and the method comprises: The content of α-lactalbumin, linoleic acid and prebiotics in the special medical purpose formula food is controlled so that the mass ratio of α-lactalbumin, linoleic acid and prebiotics is (0.25-0.6):1:(0.1-0.96); Preferably, the mass ratio of α-lactalbumin, linoleic acid and prebiotics in the special medical purpose formula food is controlled to be (0.30-0.60):1:(0.12-0.96); Further preferably, the mass ratio of α-lactalbumin, linoleic acid and prebiotics is controlled to be (0.30-0.55):1:(0.15-0.96); Further preferably, it is (0.30-0.55):1:(0.15-0.8); Further preferably, it is (0.32-0.55):1:(0.15-0.7), Further preferably, it is (0.40-0.55):1:(0.15-0.7) or (0.32-0.55):1:(0.25-0.7).

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