Method for stratifying responders

Abstract

To provide a means for designing a food and drink effective for many people from the viewpoint of responsiveness to a plurality of utilities possessed by one functional material, thereby contributing to the proposal of individualized nutrition.SOLUTION: There is provided a method for stratifying responders to a functional material, the method including a step of examining two or more kinds of changes in physical conditions and / or mental conditions in an animal group to which the functional material has been administered to detect one or more kinds of changes, and a step of classifying an animal individual in which the change has been detected into a responder group related to the change.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to a method for assessing responsiveness to a functional material from the perspective of multiple usefulness, and more particularly to a method for stratifying responders to a functional material, a method for determining the usefulness of a functional material for two or more responder groups, and a method for determining the responsiveness of an animal to a functional material. [Background technology]

[0002] Due to health-conscious trends, interest in foods and beverages that have some kind of functionality for the mind and body is growing, and the market for such products is expanding. As a result, the usefulness of various functional ingredients, including prebiotics and probiotics, is being investigated, and foods and beverages that can be sold and used as supplements to help maintain and promote health are being developed. Since people respond differently to functional ingredients, in order to increase the number of people who can expect the effects of a food product that claims a single usefulness, it has been proposed to select multiple functional ingredients that contribute to that usefulness and create a composition (Patent Document 1).

[0003] It is known that the intestinal flora and metabolites of intestinal bacteria differ from person to person, and that even if the same nutrients are consumed, the health effects that are achieved vary. For this reason, the idea of ​​"personalized nutrition" has been advocated in recent years, which provides and instructs more effective dietary methods tailored to the individual's intestinal flora. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Patent No. 7336168 Summary of the Invention [Problem to be solved by the invention]

[0005] As mentioned above, responsiveness to functional materials varies from person to person, and conventionally, responsiveness has been assessed for each individual from the perspective of usefulness, as shown in Patent Document 1. For example, with regard to the usefulness of promoting the proliferation of bifidobacteria in the intestine, individuals who ingest prebiotics are classified as responders if bifidobacteria proliferate in the intestine, and as non-responders if they do not. However, when ingesting a single functional ingredient, there is often more than one expected benefit, and there may be responders and non-responders to each benefit. While there have been no previous examples of examining the usefulness of functional ingredients from multiple angles and considering responsiveness to functional ingredients from the perspective of multiple benefits, this is thought to be significant from the perspective of effectively utilizing functional ingredients. Furthermore, the selection of such functional ingredients and the selection of target individuals for consumption is thought to be extremely significant from the perspective of personalized nutrition. In this situation, the objective is to provide a means for designing foods and beverages that are effective for many people from the perspective of responsiveness to the multiple usefulness of a single functional ingredient, thereby contributing to the proposal of personalized nutrition. [Means for solving the problem]

[0006] As a result of intensive research to solve the above-mentioned problems, the inventors discovered that by investigating the responsiveness to each of the multiple usefulness of functional ingredients, it is possible to stratify responders and determine the usefulness of functional ingredients. They then realized that this would be useful in designing foods and beverages that can be expected to be effective for a wide range of targets, and thus completed the present invention.

[0007] That is, a first aspect of the present invention is a method for stratifying responders to a functional material, which comprises the steps of investigating two or more types of changes in physical condition and / or mental condition in a group of animals administered the functional material, detecting one or more types of changes, and classifying the animals in which the changes are detected into a responder group related to the changes. In this embodiment, the change in physical state may be a favorable and / or unfavorable change in physical state, and the change in mental state may be a favorable and / or unfavorable change in mental state. In this aspect, the favorable change may be an increase, enhancement, or improvement of a positive factor, or a decrease, decrease, suppression, or delay of a negative factor, and the unfavorable change may be an increase, enhancement, or deterioration of a negative factor, or a decrease, decrease, suppression, or delay of a positive factor. In this embodiment, the investigation may be carried out by measuring positive or negative factors. In this embodiment, the change in physical state and / or the change in mental state may be two or more selected from the group consisting of the following (A) to (C): (A) Changes in intestinal bacteria (B) Changes in metabolic products (C) Fluctuations in physical symptoms or functionality and / or fluctuations in mental or neurological symptoms or functionality

[0008] A second aspect of the present invention is a method for determining the usefulness of a functional material for two or more responder groups, comprising the steps of investigating two or more changes in physical and / or mental states in each animal in a population of animals administered the functional material and detecting one or more favorable changes; classifying the individual animals in which the favorable changes were detected into responder groups related to the favorable changes; calculating, for each animal classified into the responder group, the proportion of the number of animals in the population; obtaining the sum of the proportions calculated for each responder group; and determining that the functional material is useful for two or more responders if the sum exceeds a predetermined standard value. In this embodiment, the favorable change may be an increase, enhancement, or improvement of a positive factor, or a decrease, reduction, suppression, or delay of a negative factor. In this embodiment, the investigation may be carried out by measuring positive or negative factors. In this embodiment, the favorable change in physical state and / or the favorable change in mental state may be selected from the group consisting of the following (a1) to (c1): (a1) Increase in beneficial intestinal bacteria and / or decrease in unfavorable intestinal bacteria (b1) Increase in useful metabolites and / or decrease in useless metabolites (c1) Improvement of physical symptoms or functionality and / or improvement of mental or nervous system symptoms or functionality

[0009] A third aspect of the present invention is a method for determining an animal's responsiveness to a functional material, comprising the steps of investigating changes in two or more physical and / or mental conditions when the animal is administered the functional material, and determining that the animal has a favorable responsiveness to the functional material if at least one favorable change is detected in the investigation. In this embodiment, the favorable change may be an increase, enhancement, or improvement of a positive factor, or a decrease, reduction, suppression, or delay of a negative factor. In this embodiment, the investigation may be carried out by measuring positive or negative factors. In this embodiment, the preferable change in the physical state and / or mental state may be selected from the group consisting of the following (a1) to (c1): (a1) Increase in beneficial intestinal bacteria and / or decrease in unfavorable intestinal bacteria (b1) Increase in useful metabolites and / or decrease in useless metabolites (c1) Improvement of physical symptoms or functionality and / or improvement of mental or nervous system symptoms or functionality

[0010] A fourth aspect of the present invention is an information processing system including a detection unit that investigates changes in two or more physical conditions and / or changes in mental conditions in a group of animals administered a functional material and detects one or more changes, and a classification unit that classifies individual animals in which the changes are detected into a responder group related to the changes.

[0011] A fifth aspect of the present invention is an information processing system including a detection unit that investigates two or more types of changes in physical condition and / or mental condition in each animal in a population of animals administered a functional material and detects one or more types of favorable changes; a classification unit that classifies individual animals in which the favorable changes are detected into responder groups related to the favorable changes; a calculation unit that calculates, for each animal classified into the responder group, the proportion of the number of animals in the population; a summation unit that obtains the sum of the proportions calculated for each responder group; and a determination unit that determines that the functional material is useful for two or more types of responders if the sum exceeds a predetermined standard value.

[0012] A sixth aspect of the present invention is an information processing system including a detection unit that investigates changes in two or more physical and / or mental conditions in an animal administered a functional material and detects at least one favorable change, and a judgment unit that judges an animal in which the change is detected to have a favorable responsiveness to the functional material. [Effects of the Invention]

[0013] According to the present invention, it is possible to provide a means for designing foods and beverages that are effective for many people from the perspective of responsiveness to the multiple benefits of a single functional ingredient, thereby contributing to the proposal of personalized nutritional foods. Specifically, foods and beverages containing a single functional ingredient can be designed so that they are responsive to at least one of the multiple benefits of that functional ingredient and can be expected to be effective for many people. Furthermore, consumers can determine whether a food or beverage containing a single functional ingredient can be expected to exert some effect on them, which is expected to broaden the range of people who can consume a single functional food. [Brief explanation of the drawings]

[0014] [Figure 1] 1 is a schematic diagram of the method of the first embodiment. [Figure 2] 1 is a diagram showing the steps of the method of the first embodiment. [Figure 3] A schematic diagram showing how animal groups are classified into responder groups for the multiple benefits of a single functional material. The numbers in the bottom row indicate the percentage of animals in each responder group relative to the overall population. [Figure 4] Schematic representation of the method of the second embodiment. [Figure 5] FIG. 4 is a diagram showing the steps of the method of the second embodiment. [Figure 6] Schematic diagram of the method of the third embodiment. [Figure 7] FIG. 10 is a diagram showing the steps of a method according to a third embodiment. [Figure 8] FIG. 10 is a functional block diagram of a server in the system according to the fourth embodiment. [Figure 9] FIG. 10 is a functional block diagram of a server in the system according to the fifth embodiment. [Figure 10] FIG. 10 is a functional block diagram of a server in the system according to the sixth embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0015] The present invention will now be described in detail. However, the present invention is not limited to the following embodiments and can be freely modified within the scope of the present invention. The methods of the first to third aspects of the present invention will be collectively referred to as "the method of the present invention," and the information processing systems of the fourth to sixth aspects will be collectively referred to as "the information processing system of the present invention."

[0016] <Definition> The terms used in this specification are explained below. "Functional ingredients" refer to ingredients that can exert beneficial or harmful effects on animals that ingest them. Note that this does not only include ingredients whose functionality or usefulness has actually been confirmed, but also ingredients that are candidates for having some functionality or usefulness. Examples of functional ingredients include, but are not limited to, low molecular weight compounds, plants such as vegetables and fruits, bacteria, sugars such as dietary fiber and oligosaccharides, vitamins, minerals, amino acids, peptides, and proteins.

[0017] Examples of bacteria include Bifidobacterium genus bacteria (bifidobacteria) and lactic acid bacteria. Specifically, Bifidobacterium longum subsp. longum, Bifidobacterium longum subsp. infantis, Bifidobacterium breve, Bifidobacterium Bifidobacterium bifidum and other lactic acid bacteria include Lactica Examples include Lacticaseibacillus casei, Lacticaseibacillus paracasei, Lacticaseibacillus rhamnosus, and Lactiplanti bacillus plantarum.

[0018] Examples of Bifidobacterium longum subsp. longum include Bifidobacterium longum subsp. longum ATCC 15707 and Bifidobacterium longum subsp. longum NITE BP-02621 (ATCC BAA-999; BB536). Examples of Bifidobacterium longum subsp. infantis include Bifidobacterium longum subsp. infantis ATCC 15697 and Bifidobacterium longum subsp. infantis NITE BP-02623 (M-63). Examples of Bifidobacterium breve include Bifidobacterium breve ATCC 15700, Bifidobacterium breve FERM BP-11175, and Bifidobacterium breve ATCC 15700. Examples include LebeNITE BP-02622 (M-16V). Examples of Bifidobacterium bifidum include Bifidobacterium bifidum ATCC29521 and Bifidobacterium bifidum NITE-BP-03881 (MCC2085). can be done. Examples of Lacticaceae Bacillus paracasei include Lacticaceae Bacillus paracasei JCM8130 and Lacticaceae Bacillus paracasei NITE BP-01633 (MCC 1849), Lactobacillus paracasei NITE BP-11313 (MCC1375 ) etc.

[0019] Examples of sugars include dietary fiber and oligosaccharides. Examples of dietary fiber include insoluble dietary fiber and soluble dietary fiber. Examples of insoluble dietary fiber include cellulose, hemicellulose, chitin, chitosan, etc. Examples of soluble dietary fiber include pectin, glucomannan, alginic acid, agarose, agaropectin, carrageenan, polydextrose, etc. Examples include: Examples of oligosaccharides include raffinose, lactulose, maltotriose, stachyose, galactooligosaccharides, fructooligosaccharides, kestose, nystose, soybean oligosaccharides, lactoferrin oligosaccharides, xylooligosaccharides, isomaltooligosaccharides, coffee bean mannooligosaccharides, gluconic acid, polydextrose, inulin, and human milk oligosaccharides. Human milk oligosaccharides include fucosylated oligosaccharides such as 2'-fucosyllactose (2'-FL), 3-fucosyllactose (3-FL), lacto-N-fucopentaose-I, lacto-N-fucopentaose-II, lacto-N-fucopentaose-III, difucosyllactose, lactodifucotetraose, and difucosyllactose-N-tetraose; 3'-sialyllactose (3'-SL), 6'-sialyllactose (6'-SL), and sialyllactose-N sialylated oligosaccharides such as lacto-N-tetraose a, sialyllactose-N-tetraose b, sialyllactose-N-tetraose c, and disialyllactose-N-tetraose; acetylated oligosaccharides such as lacto-N-tetraose (LNT), lacto-N-neotetraose (LNnT), and lacto-N-hexaose (LNH); galactosyl lactoses such as 3'-galactosyllactose, 4'-galactosyllactose, and 6'-galactosyllactose; and the like.

[0020] Examples of peptides and proteins include those derived from milk, soybeans, eggs, wheat, barley, rice, potatoes, sweet potatoes, peas, corn, livestock meat, fish meat, seafood, etc. Among these, those derived from milk are preferred, and casein, whey protein, and peptides derived from these are more preferred.

[0021] The term "animal" is not particularly limited, but generally refers to a mammal, preferably a human, but may also include livestock or pets such as cows, pigs, horses, sheep, dogs, cats, rabbits, rats, mice, etc. In addition to mammals, it may also include poultry such as chickens, and industrial animals such as bees and silkworms. In humans, there are no particular limitations on age, sex, or race. An "animal group" refers to a group of one or more animals. In the case of humans, such a group may be defined by, for example, race (Asian, European, etc.), nationality (Japanese, Chinese, etc.), sex (male, female, etc.), age (infants, toddlers, elementary school students, elderly, etc.). It may also be defined as a group of specific people belonging to a specific community, such as residents of a nursing home, children at a specific elementary school, children at a specific nursery school, a specific family, a specific sports team, employees of a specific company, etc. It may also be a group of animals with a specific disease or symptom, animals taking a specific medication, or animals undergoing a specific treatment. It may also be a group defined by a combination of these.

[0022] "Administration" refers to the incorporation of a functional material into the body of a target animal. Administration may be synonymous with active "ingestion" by the target animal. The route of administration / ingestion is usually oral, but may also be nasal, or may be ingested / administered via a gastrostomy or enterostomy. The route of administration / ingestion may also be other parenteral routes, such as transdermal or intravenous administration.

[0023] A "responder" refers to an animal that exhibits some kind of response when administered / ingested with a functional material, while an animal that does not exhibit a response is called a "non-responder." Some kind of response includes changes in physical and / or mental state. There are responders and non-responders for each type of response, and an animal that is a responder for one type of response may also be a non-responder for other types of responses. The concepts of "responder" and "non-responder" are based on the knowledge that the action and effect of an animal when it ingests a food or drug generally differs from animal to animal depending on the differences in the intestinal flora of that animal. However, in this specification, the differences in the intestinal flora The concept is not limited to those relating to differences in responsiveness based on factors other than the target, but may be a concept in which differences in responsiveness occur in a target for some reason. A "responder group" refers to a group of responders for a certain response, and a group is established for each response, into which responders are classified. Note that one subject may belong to multiple responder groups. This is because it is expected that when one functional material is ingested, the subject may be a responder for multiple responses. "Stratification" means grouping animals based on common responsiveness attributes observed in animals administered with a functional material.

[0024] "Changes in physical state" includes both favorable and unfavorable changes in physical state. "Changes in mental state" includes both favorable and unfavorable changes in mental state. A "favorable change" may mean an improvement, enhancement, or amelioration of a physical or mental state in an animal to which the functional material is administered. In another aspect, a "favorable change" may mean an increase, enhancement, or improvement of a positive factor, or a decrease, reduction, inhibition, or delay of a negative factor. An "unfavorable change" may refer to a decrease, deterioration, or retardation of a physical or mental state in an animal to which the functional material is administered. In another aspect, an "unfavorable change" may refer to a decrease, reduction, inhibition, or retardation of a positive factor, or an increase, enhancement, or amelioration of a negative factor.

[0025] When detecting a change, it can be determined whether or not a change is detected based on a predetermined criterion such as an arbitrary cutoff value.

[0026] A "positive factor" may be a factor associated with a favorable change in the physical condition or mental state of an animal, and may mean, for example, an increase in the amount, type, or abundance ratio of beneficial intestinal bacteria, beneficial metabolic products, favorable systemic symptoms, or favorable neuropsychiatric symptoms. A "negative factor" may be a factor related to an unfavorable change in the physical condition or mental state of an animal, and may mean, for example, an unfavorable amount, type, or abundance ratio of unhelpful intestinal bacteria, unhelpful metabolic products, unfavorable systemic symptoms, or unfavorable neuropsychiatric symptoms. Changes in positive and negative factors can be observed in a subject animal by measuring the factor itself or a biomarker related to the factor, etc. Alternatively, changes may be observed by conducting an evaluation of the subject animal using a questionnaire or the like. An increase, enhancement, or improvement in a positive factor, or a decrease, reduction, suppression, or delay in a negative factor, is considered a "favorable change." An increase, enhancement, or worsening in a negative factor, or a decrease, reduction, suppression, or delay in a positive factor, is considered an "undesirable change."

[0027] "Altered physical state" and "altered mental state" may include alterations in gut bacteria, alterations in metabolic products, and alterations in physical symptoms or functionality and / or alterations in mental or nervous system symptoms or functionality.

[0028] "Alteration of gut bacteria" may include "alteration of favorable gut bacteria" and "alteration of unfavorable gut bacteria." "Favorable gut flora shift" may mean an increase in beneficial gut bacteria and a decrease in unfavorable gut bacteria. "Unfavorable changes in intestinal bacteria" refers to a decrease in beneficial intestinal bacteria and an increase in unfavorable intestinal bacteria. This may mean an increase in "Beneficial intestinal bacteria" refers to intestinal bacteria that can have a favorable effect on physical or mental state by growing and proliferating in the intestines. Examples include bifidobacteria (Bifidobacterium genus bacteria), lactic acid bacteria, and butyric acid bacteria. Examples of bifidobacteria include Bifidobacterium longum subsp. longum, Bifidobacterium longum subsp. infantis, Bifidobacterium breve, and Bifidobacterium Bifidobacterium bifidum, Bifidobacterium adolescentis Examples include Bifidobacterium adolescentis, Bifidobacterium catenulatum, Bifidobacterium pseudocatenulatum, Bifidobacterium animalis, Bifidobacterium lactis, and Bifidobacterium pseudolongum. Lactic acid bacteria include Lacticaseibacillus casei, Lacticaseibacillus paracasei, Lacticaseibacillus rhamnosus, Lactiplanti bacillus plantarum, Levilactobacillus brevis, Ligilactobacillus salivarius, and Limosilactobacillus fermentum. ), Limosilactobacillus reuteri, Lactobacillus Examples include Lactobacillus helveticus. Butyric acid bacteria is a general term for bacteria that produce butyric acid, and specific examples include the genus Faecalibacterium, the genus Coprococcus, and the genus Clostridium. Examples of such bacteria include bacteria belonging to the genera Clostridium, Eubacterium, and Gemmiger, and more preferably Faecalibacterium prausnitzii and Gemmiger formicilis, which are present in the human intestine.

[0029] "Unhelpful intestinal bacteria" refers to intestinal bacteria that can have an adverse effect on physical or mental states by growing and multiplying in the intestines, such as Escherichia coli, Clostridium perfringens, and Staphylococcus aureus. As for E. coli, enteropathogenic Escherichia coli, enteric pathogenic E. coli, Enteroinvasive Escherichia coli, Enterotoxigenic Escherichia coli, Enterohemorrhagic Escherichia coli ), Enteroaggregative Escherichia coli, etc.

[0030] "Metabolic product fluctuations" may include "favorable metabolic product fluctuations" and "undesirable metabolic product fluctuations." "Favorable changes in metabolic products" may mean, for example, an increase in useful metabolic products and a decrease in unuseful metabolic products. "Unfavorable fluctuations in metabolic products" may mean, for example, a decrease in useful metabolic products or an increase in unuseful metabolic products. Examples of "useful metabolites" include acetic acid, butyric acid, indole compounds, and aromatic lactic acid compounds. Examples of indole lactic acid compounds include indole-3-pyruvic acid (IPYA), indole-3-lactic acid (ILA), 3-indoleacrylic acid (IA), indole-3-propionic acid (IPA), indole-3-acetaldehyde (IAAId), indole-3-acetic acid (IAA), and indole-3-aldehyde (IAId). Examples of aromatic lactic acid compounds include indole-3-lactic acid (ILA), phenyllactic acid (PLA), and 4-hydroxyphenyllactic acid (HPLA). Examples of "useless metabolic products" include ammonia, hydrogen sulfide, and the like.

[0031] "Changes in physical symptoms or functionality" may include "favorable changes in physical symptoms or functionality" and "undesirable changes in physical symptoms or functionality." "Favorable physical symptoms or functional changes" may include, for example, an increase in the frequency of bowel movements, improved sleep quality, suppression of blood sugar levels, lowered blood pressure, relief from atopic dermatitis and allergies, improved skin condition, improved memory, and other improvement, suppression, or delay of symptoms, improved functionality, etc. "Undesirable physical symptoms or functional changes" may include, for example, decreased bowel movements, constipation, diarrhea, abdominal pain, loss of appetite, increased blood sugar levels, increased blood pressure, headache, dizziness, slight fever, fatigue, lethargy, poor sleep (insomnia, excessive sleep, shallow sleep), worsening of atopic dermatitis or allergies, worsening skin condition, decreased memory, and other worsening or progression of symptoms, decreased functionality, etc.

[0032] "Alterations in mental or nervous system symptoms or functionality" may include "favorable alterations in mental or nervous system symptoms or functionality" and "undesirable alterations in mental or nervous system symptoms or functionality." "Favorable changes in mental or nervous system symptoms or functionality" include improved motivation and concentration, and relief of anxiety. "Unwanted mental or nervous system symptoms or functional changes" include anxiety, depression, gloomy mood, loss of motivation or concentration, restlessness, sadness, irritability, etc.

[0033] <First Aspect> A first aspect of the present invention is a method for stratifying responders by assessing the usefulness of a functional material from multiple perspectives and classifying them into responder groups corresponding to each usefulness. Specifically, this method for stratifying responders to a functional material includes the steps of: investigating two or more physical and / or mental changes in a group of animals administered the functional material; detecting one or more changes; and classifying the animals in which such changes are detected into the responder group associated with the changes (Figure 1). In this aspect, the detecting and classifying steps may be performed using a computer. In this embodiment, the change in physical state may be a favorable and / or unfavorable change in physical state, and the change in mental state may be a favorable and / or unfavorable change in mental state. In this aspect, the favorable change may be an increase, enhancement, or improvement of a positive factor, or a decrease, decrease, suppression, or delay of a negative factor, and the unfavorable change may be an increase, enhancement, or deterioration of a negative factor, or a decrease, decrease, suppression, or delay of a positive factor. In this embodiment, the investigation may be carried out by measuring positive or negative factors. In this embodiment, the change in physical state and / or the change in mental state may be two or more selected from the group consisting of the following (A) to (C): (A) Changes in intestinal bacteria (B) Changes in metabolic products (C) Fluctuations in physical symptoms or functionality and / or fluctuations in mental or neurological symptoms or functionality

[0034] The procedure for carrying out this embodiment will be explained with reference to Figure 2. The functional material is administered to a group of animals (S101), and two or more types of changes in physical state and / or mental state (for example, A, B, and C, but not limited to three types) are investigated in the administered group of animals (S102), and one or more types of changes A, B, and C are detected in the group of animals (S103). It is determined whether or not a change has been detected in the group of animals (S110), and if a change has been detected, Animals in which a change has been detected are classified into a responder group related to the change (S111, S112, S113), and animals in which no change has been detected are classified into a non-responder group (S114). The changes in physical state and / or mental state may be of two or more types, preferably three or more types, four or more types, five or more types, ten or more types, or twenty or more types.

[0035] Referring to FIG. 3, an example of applying this procedure to a subject group is described. For example, in a group of animals including subjects A to C that have been administered a certain functional material, changes related to three usefulness factors, namely, changes in intestinal bacteria, changes in metabolic products, and changes in physical or mental functionality, are investigated. Subject B shows an increase in intestinal bacteria after ingestion of the functional material, and is recognized as a responder related to usefulness A and is classified into the responder group. Subjects A and C show an increase in metabolic products after ingestion of the functional material, and are recognized as responders related to usefulness B and are classified into the responder group. Subject C shows an improvement in functionality after ingestion of the functional material, and is recognized as a responder related to usefulness C and is classified into the responder group. In this way, responders to the functional material are stratified according to usefulness A to C. This allows animal groups to be stratified according to the multiple benefits of a single functional ingredient, making it possible to propose foods and beverages that are suitable for subjects who can expect multiple benefits from a food or beverage containing a single functional ingredient.

[0036] <Second aspect> A second aspect of the present invention is a method for assessing the usefulness of a functional ingredient from multiple perspectives and determining whether the functional ingredient covers multiple responder groups corresponding to each of the usefulness. Specifically, this method for determining the usefulness of a functional ingredient for two or more responder groups includes the steps of: investigating two or more physical and / or mental changes in each animal in a population of animals administered the functional ingredient, detecting one or more favorable changes; classifying the animals in which the favorable changes were detected into the responder groups associated with the favorable changes; calculating the proportion of each animal in each responder group to the population; summing the calculated proportions for each responder group; and determining that the functional ingredient is useful for two or more responders if the sum exceeds a predetermined threshold (Figure 4). In this aspect, the steps of detecting, classifying, calculating, summing, and determining may be performed using a computer. In this embodiment, the favorable change may be an increase, enhancement, or improvement of a positive factor, or a decrease, reduction, suppression, or delay of a negative factor. In this embodiment, the investigation may be carried out by measuring positive or negative factors. In this embodiment, the favorable change in physical state and / or the favorable change in mental state may be selected from the group consisting of the following (a1) to (c1): (a1) Increase in beneficial intestinal bacteria and / or decrease in unfavorable intestinal bacteria (b1) Increase in useful metabolites and / or decrease in useless metabolites (c1) Improvement of physical symptoms or functionality and / or improvement of mental or nervous system symptoms or functionality

[0037] The procedure for carrying out this embodiment will be explained with reference to Figure 5. The functional material is administered to a group of animals (S201), and two or more types of changes in physical state and / or mental state (for example, A, B, C, but not limited to three types) are investigated in each animal in the population of the administered group of animals (S202), and one or more types of favorable changes among the changes A, B, C in the group of animals are detected (S203). The functional material is determined to be effective for two or more types of responders (S241). Animals in which favorable changes are detected are classified into responder groups according to the favorable changes (S211, S212, S213). The proportion of each animal in each responder group to the overall population is calculated for each responder group (S221, S222, S223). The proportions calculated for each responder group are summed (S231). If the sum exceeds a predetermined threshold, the functional material is determined to be effective for two or more types of responders (S241). Animals in which no changes are detected are classified into a non-responder group (S214). The changes in physical state and / or mental state may be of two or more types, preferably three or more types, four or more types, five or more types, ten or more types, or twenty or more types.

[0038] Referring to FIG. 3, an example of applying this procedure to a subject group is shown. For example, a group of animals including subjects A to C is administered a certain functional material, and changes related to three usefulness factors—changes in intestinal bacteria, changes in metabolic products, and changes in physical or mental functionality—are investigated. Subject B exhibits an increase in beneficial intestinal bacteria after ingestion of the functional material, and is therefore recognized as a responder related to usefulness A and classified into the responder group. Subjects A and C exhibit an increase in beneficial metabolic products after ingestion of the functional material, and are therefore recognized as responders related to usefulness B and classified into the responder group. Subject C exhibits a favorable improvement in functionality after ingestion of the functional material, and is therefore recognized as a responder related to usefulness C and classified into the responder group. For each subject classified into each responder group, the proportion of the number of subjects in each responder group to the total population is calculated. For example, since the number of responders related to usefulness A (1 person) is compared to the total population (3 people), the responder proportion is 33%. Similarly, the percentage of responders for utility B is 66%, and the percentage of responders for utility C is 33%. The sum of the percentages calculated for each responder group is 133%. This sum serves as an index of the range of subjects who are suitable for ingesting a single functional ingredient and who are expected to experience the effects of utilities A to C. The higher the sum, the more likely the functional ingredient is to be deemed useful for two or more types of responders. This determination is based on whether the sum exceeds a predetermined reference value. This reference value can be set appropriately depending on the number of utilities and responder groups to be evaluated. For example, it may be 50% or more, 60% or more, 70% or more, 80% or more, 90% or more, 100% or more, 110% or more, 120% or more, 130% or more, or 140% or more. In addition, since a subject may respond to multiple usefulness aspects when ingesting a single functional ingredient (for example, subject C in Figure 3), the standard total value may exceed 100%. In this way, the usefulness of a single functional ingredient can be determined for two or more responder groups, making it possible to design foods and beverages containing a single functional ingredient that are responsive to at least one of the multiple benefits of that functional ingredient and that are expected to be effective for many people.

[0039] <Third Aspect> A third aspect of the present invention is a method for assessing the usefulness of a functional ingredient from multiple perspectives and determining whether a target animal falls into one of the responder groups corresponding to each usefulness. Specifically, this method for determining an animal's responsiveness to a functional ingredient includes the steps of investigating changes in two or more physical and / or mental conditions when the animal is administered the functional ingredient, and determining that the animal has a favorable responsiveness to the functional ingredient if at least one favorable change is detected in the investigation (Figure 6). This can also be considered another aspect of the stratification method of the first aspect. In this aspect, the investigating and determining steps may be performed using a computer. In this embodiment, the favorable change may be an increase, enhancement, or improvement of a positive factor, or a decrease, reduction, suppression, or delay of a negative factor. In this embodiment, the investigation may be carried out by measuring positive or negative factors. In this embodiment, the preferable change in the physical state and / or mental state may be selected from the group consisting of the following (a1) to (c1): (a1) Increase in beneficial intestinal bacteria and / or decrease in unfavorable intestinal bacteria (b1) Increase in useful metabolites and / or decrease in useless metabolites (c1) Improvement of physical symptoms or functionality and / or improvement of mental or nervous system symptoms or functionality

[0040] 7, the procedure for carrying out this embodiment is as follows: the functional material is administered to an animal (S301), and the animal is examined for two or more types of physical and / or mental changes (e.g., A, B, and C, but not limited to three) (S302), and at least one favorable change among changes A, B, and C is detected in the animal (S303). It is determined whether a change is detected in the animal (S310), and an animal in which a change is detected is determined to be a responder related to any of changes A, B, or C (S311), and an animal in which no change is detected is determined to be a non-responder (S312). The preferred changes in physical state and / or preferred changes in mental state may be of two or more types, preferably three or more types, four or more types, five or more types, ten or more types, or twenty or more types.

[0041] 3, the application of this procedure to a subject group will be explained. For example, in subject A who has been administered a certain functional material, changes related to three usefulness factors, namely, changes in intestinal bacteria, changes in metabolic products, and changes in physical or mental functionality, are investigated. Although an increase in beneficial intestinal bacteria and an improvement in desirable functionality were not observed in subject A after taking the functional material, an increase in beneficial metabolic products was observed, and subject A was recognized as a responder related to usefulness B. Therefore, subject A is determined to have a favorable responsiveness to the functional material. In this way, a responder who is responsive to the functional material is determined, and such a responder is considered to be a subject who can obtain at least one of the benefits 1 to 3 from the functional material. In this way, it is possible to determine an animal's responsiveness to functional ingredients, and for foods and beverages containing a single functional ingredient with multiple useful properties, it is possible to find subjects in which at least one of the effects of the multiple useful properties can be expected to be exerted, making it possible to propose foods and beverages that are suitable for a wide range of subjects.

[0042] <Information Processing System of the Present Invention> The information processing system of the present invention includes a server, which is connected to one or more user terminals via a network such as the Internet. An example of the configuration of the server and user terminal in the information processing system of the present invention will be given below, but the present invention is not limited to this.

[0043] A server may be a general-purpose computer such as a workstation or personal computer, or may be logically realized through cloud computing. A server typically includes at least a processor, memory, storage, a transmitter / receiver, and an input / output unit, all of which are electrically connected to each other via a bus. The processor is a computing device that controls the operation of the entire server, controls the transmission and reception of data between each element, and performs information processing necessary for executing applications. For example, the processor is a CPU (Central Processing Unit), which executes programs stored in storage and deployed in memory to perform various information processing operations. Memory is DRAM (Dynamic Random Access Memory), etc. The main memory is made up of volatile storage devices such as flash memory and HDD (Hard Disk Drive). The memory includes auxiliary storage consisting of non-volatile storage devices such as a processor. It is used as a work area for the processor, and also stores the BIOS (Basic Input / Output System) that is executed when the server starts up, as well as various setting information. do. The storage stores various programs such as application programs. A database that stores data used for each process may also be built in the storage. The transmitting / receiving unit connects the server to the network. The transmitting / receiving unit may include a short-range communication interface such as Bluetooth (registered trademark) and Bluetooth Low Energy (BLE). The input / output section includes information input devices such as a keyboard and mouse, which are used as needed, and output devices such as a display. A bus 15 is commonly connected to the above elements and transmits, for example, address signals, data signals and various control signals.

[0044] The user terminal executes information processing via communication with the server. The user terminal may be, for example, a general-purpose computer such as a workstation or a personal computer, or a mobile communication device such as a smartphone.

[0045] <Fourth aspect> A fourth aspect of the present invention is an information processing system including: a detection unit that investigates changes in two or more physical conditions and / or changes in mental conditions in a group of animals administered with a functional material, and detects one or more changes; and a classification unit that classifies the animals in which the changes are detected into a responder group related to the changes. The system of the fourth aspect may be one of the means for carrying out the method of the first aspect. An example of the software configuration of the server in the system of this embodiment will be explained with reference to Figure 8. The server can be equipped with a detection unit 111, a classification unit 112, an investigation information storage unit 121, a detection result storage unit 122, a classification information storage unit 123, and an additional information storage unit 124. The detection unit 111 and the classification unit 112 are realized by a processor provided in the server reading out a program stored in storage into memory and executing it, and the investigation information storage unit 121, the detection result storage unit 122, the classification information storage unit 123, and the additional information storage unit 124 are realized as part of the storage area provided by the memory and / or storage.

[0046] The detection unit 111 detects one or more changes from information obtained by investigating two or more physical and / or mental changes in a group of animals administered with a functional material. The detection unit 111 may obtain the investigation results from a user terminal or an investigation information storage unit 121 in the server, or may obtain them via a separate data server. The detection is performed in light of a predetermined cutoff value, etc. The detected results are transmitted to the detection result storage unit 122. The classification unit 112 classifies the individual animal in which a change has been detected into a responder group related to the change, based on the information acquired from the detection result storage unit 122. One individual animal may be classified into multiple groups. Information on the classified responder groups is transmitted to the classification information storage unit 123. The survey information storage unit 121 includes information on functional ingredients and data on two or more types of changes in physical and / or mental conditions in a group of animals administered with the functional ingredients. The survey information includes, for example, information on changes in physical and / or mental conditions linked to IDs assigned to each functional ingredient or each individual animal. The detection result storage unit 122 contains information on the animal group in which a change was detected by the detection unit. The classification information storage unit 123 stores information on the responder groups classified by the classification unit, The information includes information on corresponding changes in physical state and / or mental state, and such information may be provided to a user terminal or the like. The additional information storage unit 124 stores information to be added to the detection results and classification information, such as detailed information on changes in the physical and / or mental conditions of responders, and information on individuals classified into multiple responder groups.

[0047] <Fifth Aspect> A fifth aspect of the present invention is an information processing system including: a detection unit that investigates two or more physical and / or mental changes in each animal in a population of animals administered a functional material and detects one or more favorable changes; a classification unit that classifies the animals in which the favorable changes are detected into responder groups related to the favorable changes; a calculation unit that calculates the proportion of each animal in each responder group to the population; a totalization unit that obtains the sum of the calculated proportions for each responder group; and a determination unit that determines that the functional material is effective for two or more responders if the sum exceeds a predetermined reference value. The system of the fifth aspect may be one of the means for carrying out the method of the second aspect. An example of the software configuration of the server in the system of this embodiment will be explained with reference to Figure 9. The server can be equipped with a detection unit 211, a classification unit 212, a calculation unit 213, a totalization unit 214, a judgment unit 215, an investigation information storage unit 221, a detection result storage unit 222, a classification information storage unit 223, a ratio information storage unit 224, a total information storage unit 225, a judgment information storage unit 226, and an additional information storage unit 227. The detection unit 211, classification unit 212, calculation unit 213, totalization unit 214, and judgment unit 215 are realized by a processor provided in the server reading out programs stored in storage into memory and executing them, and the investigation information storage unit 221, detection result storage unit 222, classification information storage unit 223, ratio information storage unit 224, total information storage unit 225, judgment information storage unit 226, and additional information storage unit 227 are realized as part of the storage area provided by the memory and / or storage.

[0048] The detection unit 211 detects one or more desirable changes from information obtained by surveying two or more physical and / or mental state changes in each animal in a population of animals administered with the functional material. The detection unit 211 may obtain the survey results from a survey information storage unit 221 in a user terminal or server, or may obtain them via a separate data server. The detection is performed in light of a predetermined cutoff value, etc. The detected results are transmitted to the detection result storage unit 222. The classification unit 212 classifies the individual animals in which a favorable change has been detected into a responder group related to the favorable change, based on the information acquired from the detection result storage unit 222. One individual animal may be classified into multiple groups. Information on the classified responder groups is transmitted to the classification information storage unit 223. The calculation unit 213 calculates the ratio of the number of animals classified into the responder group to the population for each responder group based on the information acquired from the classification information storage unit 223. The calculated ratio is transmitted to the ratio information storage unit 224. The totaling unit 214 obtains the total value of the ratios calculated for each responder group based on the information obtained from the ratio information storage unit 224. The total value information is transmitted to the total information storage unit 225. Based on the information acquired from the total information storage unit 225, the judgment unit 215 judges whether the total value exceeds a predetermined reference value, and if it does, judges that the functional material is useful for two or more types of responders. The investigation information storage unit 221 contains information on the functional material and data on changes in two or more physical conditions and / or mental conditions in a group of animals administered with the functional material. The inspection information includes, for example, information on changes in physical and mental conditions linked to an ID assigned to each functional material or each individual animal. The detection result storage unit 222 contains information on the animal group in which a change was detected by the detection unit. The classification information storage unit 223 includes information on the responder groups classified by the classification unit and information on the corresponding changes in physical condition and / or mental condition. Such information may be provided to a user terminal or the like. The ratio information storage unit 224 includes the ratio of the number of animals in each responder group to the population calculated by the calculation unit. The total information storage unit 225 includes information on the total value of the ratio calculated for each responder group acquired in the totaling unit. The determination information storage unit 226 includes information related to the usefulness of the functional ingredient determined by the determination unit, such as the type of usefulness covered by the functional ingredient or information on the attributes of the responder. The additional information storage unit 227 stores information to be added to the detection results, classification information, ratio information, total information, and judgment information, such as detailed information on functional ingredients whose usefulness has been judged, detailed information on changes in the physical and / or mental conditions of responders, and information on individuals classified into multiple responder groups.

[0049] <Sixth Aspect> A sixth aspect of the present invention is an information processing system including: a detection unit that investigates changes in two or more physical and / or mental states in an animal administered with a functional material and detects at least one favorable change; and a determination unit that determines an animal in which the change is detected as having a favorable responsiveness to the functional material. The system of the sixth aspect may be one of the means for carrying out the method of the third aspect. An example of the software configuration of the server in the system of this embodiment will be explained with reference to Figure 10. The server can be equipped with a detection unit 311, a judgment unit 312, an investigation information storage unit 321, a detection result storage unit 322, a judgment information storage unit 323, and an additional information storage unit 324. The detection unit 311 and the judgment unit 312 are realized by a processor provided in the server reading out a program stored in storage into memory and executing it, and the investigation information storage unit 321, the detection result storage unit 322, the judgment information storage unit 323, and the additional information storage unit 324 are realized as part of the memory and / or storage area provided by the storage.

[0050] The detection unit 311 detects at least one desirable change from information obtained by investigating two or more physical and / or mental changes in a group of animals administered with the functional material. The detection unit 311 may obtain the investigation results from a user terminal or an investigation information storage unit 321 in the server, or via a separate data server. The detection is performed in light of a predetermined cutoff value, etc. The detected results are transmitted to the detection result storage unit 322. The determining unit 312 determines that the animal in which the change was detected has a desirable responsiveness to the functional ingredient. Information on the determination result is transmitted to the determination information storage unit 323. The survey information storage unit 321 includes information on functional ingredients and data on at least one desirable change in physical condition and / or desirable change in mental condition in a group of animals administered with the functional ingredients. The survey information includes, for example, information on changes in physical condition and / or changes in mental condition linked to an ID assigned to each functional ingredient or each individual animal. The detection result storage unit 322 contains information on the physical condition and / or mental condition in which a change has been detected by the detection unit. The determination information storage unit 323 includes information on the individual animal determined by the determination unit and information on the corresponding favorable changes in physical condition and / or favorable changes in mental condition. Such information may be provided to a user terminal or the like. The additional information storage unit 324 stores information to be added to the detection results and classification information. Examples of such information include detailed information on favorable changes in physical and / or mental states in individual animals determined to have a favorable responsiveness to functional materials, as well as information on the number of types of such favorable changes.

[0051] <Composition containing functional ingredients> The functional ingredients prepared by the method of the present invention can be incorporated into any composition to be used in the form of foods and beverages, food additives, pharmaceuticals, etc. In a preferred embodiment, such compositions can be advertised (labeled) with the uses and functionality of the incorporated functional ingredients. The composition may be in any form, such as liquid, paste, gel-like solid, or powder, as a food or drink, including, for example, tablet confectionery; liquid food (nutritional food for tube feeding); wheat flour products such as bread, macaroni, spaghetti, noodles, cake mix, fried chicken powder, and breadcrumbs; instant noodles, cup noodles, retort and cooked foods, canned foods, microwave foods, instant soups and stews, instant miso soup and clear soups, canned soups, freeze-dried foods, and other instant foods; canned agricultural products, canned fruit, and jalapenos. Agricultural processed products such as marmalades, pickles, boiled beans, dried agricultural goods, and cereals (processed grain products); canned seafood, fish ham and sausages, fish paste products, seafood delicacies, and tsukudani (fish stews) among other processed seafood products; canned livestock products and pastes, livestock ham and sausages among other processed livestock products; processed milk, milk drinks, yogurt, lactic acid bacteria drinks, cheese, ice cream, infant formula, cream, and other dairy products; butter, margarines, vegetable oils, and other fats and oils; soy sauce, miso, and sauces Basic seasonings such as tomato seasonings, mirin, vinegars, etc.; complex seasonings and foods such as cooking mixes, curry bases, sauces, dressings, noodle soups, spices, and other complex seasonings; frozen foods such as frozen ingredients, semi-cooked frozen foods, and cooked frozen foods; confectioneries such as caramel, candy, chewing gum, chocolate, cookies, biscuits, cakes, pies, snacks, crackers, Japanese sweets, rice snacks, bean snacks, desserts, jellies, and other sweets. ; carbonated drinks, natural fruit juice, fruit juice drinks, soft drinks with fruit juice, fruit pulp drinks, fruit drinks with fruit particles, vegetable drinks, soy milk, soy milk drinks, coffee drinks, tea drinks, powdered drinks, concentrated drinks, sports drinks, nutritional drinks, alcoholic drinks, other beverages, and other commercially available foods such as baby food, furikake, and ochazuke nori seaweed; infant formula; enteral nutritional foods; health functional foods (foods for specified health uses, foods with nutrient functions, foods with functional claims), nutritional supplements such as supplements, etc.

[0052] When the compound is made into a supplement form as a food or beverage, it can be formulated into solid preparations such as powders, granules, tablets, capsules, etc., which may be enteric-coated with an enteric coating, etc.; or liquid preparations such as solutions, syrups, suspensions, emulsions, etc.

[0053] When the composition is a food or beverage and claims (displays) the uses or functionality related to the usefulness of the functional ingredients contained therein, it is preferable to also display it as a health food, functional food, enteral nutritional food, special purpose food, health functional food, food for specified health uses, nutrient functional food, food with functional claims, quasi-drug, etc.

[0054] Furthermore, one aspect of the food and drink product may be feed, such as pet food, livestock feed, and fish feed.

Claims

1. A method for stratifying responders to a functional material, comprising: A step of investigating changes in two or more physical conditions and / or changes in mental conditions in a group of animals administered with the functional material, and detecting one or more changes; classifying the animal in which the change was detected into a responder group related to the change.

2. the change in physical condition is a favorable change and / or an unfavorable change in physical condition, 2. The method of claim 1, wherein the change in mental state is a positive and / or negative change in mental state.

3. The favorable change is an increase, enhancement, or improvement of a positive factor, or a decrease, reduction, suppression, or delay of a negative factor; The method of claim 2, wherein the unfavorable change is an increase, enhancement, or worsening of a negative factor, or a decrease, reduction, suppression, or delay of a positive factor.

4. The method of claim 1 , wherein the investigation is performed by measuring positive or negative factors.

5. The method according to claim 1, wherein the change in physical condition and / or the change in mental condition is two or more selected from the group consisting of the following (A) to (C): (A) Changes in intestinal bacteria (B) Changes in metabolic products (C) Fluctuations in physical symptoms or functionality and / or fluctuations in mental or neurological symptoms or functionality

6. A method for determining the usefulness of a functional material for two or more responder groups, comprising: a step of investigating changes in two or more physical conditions and / or changes in mental conditions in each animal in the population of animals administered with the functional material, and detecting one or more favorable changes; classifying the animal in which the favorable change has been detected into a responder group related to the favorable change; Calculating the proportion of the number of animals in each responder group to the population for each responder group; A step of obtaining a sum of the calculated ratios for each responder group; and and determining that the functional material is useful for two or more types of responders when the total value exceeds a predetermined reference value.

7. The method of claim 6, wherein the favorable change is an increase, enhancement, or improvement of a positive factor, or a decrease, reduction, suppression, or delay of a negative factor.

8. The method of claim 7, wherein the investigation is performed by measuring positive or negative factors.

9. The method according to claim 6, wherein the favorable change in physical state and / or the favorable change in mental state is selected from the group consisting of the following (a1) to (c1): (a1) Increase in beneficial intestinal bacteria and / or decrease in unbeneficial intestinal bacteria (b1) Increase in useful metabolites and / or decrease in useless metabolites (c1) Improvement of physical symptoms or functionality and / or improvement of mental or nervous system symptoms or functionality

10. A detection unit that investigates two or more types of changes in physical conditions and / or mental conditions in a group of animals administered with the functional material and detects one or more types of changes; and An information processing system including a classification unit that classifies the animal individual in which the change has been detected into a responder group related to the change.

11. a detection unit that investigates changes in two or more physical conditions and / or changes in mental conditions in each animal in a population of animals administered with the functional material and detects one or more favorable changes; a classification unit that classifies the animal individual in which the favorable change has been detected into a responder group related to the favorable change; a calculation unit that calculates, for each animal classified into the responder group, a ratio of the number of animals to the population; a summation unit for obtaining a sum of the calculated ratios for each responder group; and An information processing system including a determination unit that determines that the functional material is useful for two or more types of responders when the total value exceeds a predetermined reference value.

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