CN119584873A - Composition and use thereof - Google Patents
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- CN119584873A CN119584873A CN202380052128.XA CN202380052128A CN119584873A CN 119584873 A CN119584873 A CN 119584873A CN 202380052128 A CN202380052128 A CN 202380052128A CN 119584873 A CN119584873 A CN 119584873A
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/733—Fructosans, e.g. inulin
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/135—Bacteria or derivatives thereof, e.g. probiotics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/66—Microorganisms or materials therefrom
- A61K35/74—Bacteria
- A61K35/741—Probiotics
- A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
- A61K35/745—Bifidobacteria
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/66—Microorganisms or materials therefrom
- A61K35/74—Bacteria
- A61K35/741—Probiotics
- A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
- A61K35/747—Lactobacilli, e.g. L. acidophilus or L. brevis
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Molecular Biology (AREA)
- Nutrition Science (AREA)
- Engineering & Computer Science (AREA)
- Food Science & Technology (AREA)
- Polymers & Plastics (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Abstract
披露了用于预防或治疗失眠、改善睡眠质量、改善皮肤外观、减少口臭并且增加睡眠放松、改善睡眠质量的组合物。特别地,这些组合物包含选自下组的益生菌,该组包含:乳酪杆菌属物种、双歧杆菌属物种或其组合;以及任选地益生元纤维。Compositions for preventing or treating insomnia, improving sleep quality, improving skin appearance, reducing bad breath, and increasing sleep relaxation, improving sleep quality are disclosed. In particular, these compositions comprise probiotics selected from the group consisting of: Lactobacillus species, Bifidobacterium species, or a combination thereof; and optionally prebiotic fibers.
Description
Technical Field
The present invention relates to a composition for preventing or treating insomnia, improving skin appearance, reducing halitosis, and increasing sleep relaxation and improving sleep quality.
Background
The sleeping time varies from person to person. Seven to eight hours per night are considered necessary for most adults. As aging progresses, the internal sleeping biological clock begins to lose consistency. Thus, elderly people tend to feel tired earlier in the evening, wake earlier in the morning, resulting in less overall sleep and increased risk of cognitive decline. Elderly people suffering from alzheimer's disease, dementia or other neurodegenerative diseases experience more severe changes in sleep driving.
More and more adults experience short-term acute insomnia lasting days or weeks at certain moments in life. This is typically the result of a stress or trauma event. However, some people suffer from long-term chronic insomnia, which may itself be a major problem, and may be associated with other medical conditions or medications.
The data show that over 3 hundred million chinese experience poor sleep quality, sleep disorders or insomnia. Individuals with poor sleep quality or insomnia often feel tired after waking up and have a negative impact on energy levels, mood and overall health, performance and quality of life.
A large number of individuals with poor sleep quality and/or insomnia motivate the consumption of sleep aid products. In recent years, various types of sleep monitoring and support software have been subsequently brought on-line at the primary APP store. In addition, latex pillows, sleep aids, aromatherapy lamps, melatonin, sleep soft sweets, etc. are often used to aid sleep.
CN104187613 discloses a nutritional formula for insomnia, which comprises traditional Chinese medicine, probiotics, water-soluble prebiotic fiber and the like.
CN107496850 discloses a preparation for regulating intestinal microecology with ginseng to tranquilize the mind and aid sleep.
CN107874251 discloses an eight delicacies probiotic composition comprising 1-9 parts of a chinese herbal extract, 0.01-2 parts of a food grade probiotic and 0.1-5 parts of a prebiotic.
Adult, especially elderly people, are more likely to suffer from poor sleep quality due to various causes such as depression caused by work pressure, activity restriction, interpersonal disputes, etc. However, people are reluctant to seek drug treatment. Thus, there remains a need for improved nutritional intervention to induce relaxation and treat insomnia in a simple and convenient manner.
Disclosure of Invention
In a study for more than 200 adults, the inventors observed that sleep induction and quality, mood were significantly improved and psychological stress was reduced when a composition comprising a combination of prebiotic soluble fiber and probiotic bacterial strain was administered to a subject. Unexpectedly, this improvement was observed within 7 days of the start of administration of the composition according to the invention.
Accordingly, in one aspect, the present invention relates to a composition for use in the prevention and/or treatment of insomnia in a human subject, the composition comprising:
a.10 3 to 10 12 colony forming units/g of the composition, the at least one probiotic being selected from the group comprising Lactobacillus species, bifidobacterium species or a combination thereof, and optionally,
B. And 11wt% or more of prebiotic fiber based on the total weight of the composition.
In a second aspect, the present invention relates to a non-therapeutic method of improving sleep quality, and/or inducing and/or enhancing pre-sleep relaxation, the method comprising administering to a human subject in need thereof a composition, wherein the composition comprises:
a.10 3 to 10 12 colony forming units/g of the composition, the at least one probiotic being selected from the group comprising a Lactobacillus species, a Bifidobacterium species, or a combination thereof, and optionally
B. And 11wt% or more of prebiotic fiber based on the total weight of the composition.
Herein, induction and/or enhancement of pre-sleep relaxation is compared to a human subject not administered the composition according to the invention. Individual experiences may be assessed by professional questionnaires (including digital questionnaires) or determined by mental and psychiatric care professionals.
Furthermore, the inventors have unexpectedly observed a significant improvement in skin appearance and condition, and a reduction in bad breath.
In a third aspect, the present invention relates to a non-therapeutic method of reducing halitosis, the method comprising administering to a human subject in need thereof a composition, wherein the composition comprises:
a.10 3 to 10 12 colony forming units/g of the composition, the at least one probiotic being selected from the group comprising a Lactobacillus species, a Bifidobacterium species, or a combination thereof, and optionally
B. And 11wt% or more of prebiotic fiber based on the total weight of the composition.
Halitosis reduction is defined herein as compared to a subject not administered a composition according to the invention. Individual sensations can be assessed by a professional questionnaire or determined by a dental care professional.
In a fourth aspect, the present invention relates to a non-therapeutic method of improving the appearance and texture of skin, the method comprising administering to a human subject in need thereof a composition, wherein the composition comprises:
a.10 3 to 10 12 colony forming units/g of the composition, the at least one probiotic being selected from the group comprising a Lactobacillus species, a Bifidobacterium species, or a combination thereof, and optionally
B. And 11wt% or more of prebiotic fiber based on the total weight of the composition.
Improvement in skin appearance and texture is defined herein as compared to a subject not administered a composition according to the invention. The individual experiences may be assessed by a professional questionnaire or determined by a skin care professional (e.g., a cosmetologist).
In a fifth aspect, the present invention relates to a composition comprising:
i. At least 40wt.% carbohydrate based on the total weight of the composition,
Not less than 85wt.% of prebiotic soluble fiber based on the total weight of carbohydrate,
10 3 To 10 12 colony forming units/g of at least one probiotic of the composition, the at least one probiotic being selected from the group comprising Lactobacillus species, bifidobacterium species or a combination thereof
Wherein the composition does not comprise lactose.
In all aspects of the invention, the composition is preferably a synbiotic composition.
As defined herein, the composition is an enteral composition, preferably an oral composition.
Detailed Description
"Probiotic" means a microbial cell preparation or microbial cell component that has a beneficial effect on the health or well-being of a host. (SALMINEN S, ouwehand A.Benno Y et al, '' Probiotics: how should they be defined [ Probiotics: how they should be defined ] '' Trends Food ScL Technol [ food technology trend ] 1999:10107-10).
As used herein, "synbiotics" refers to compositions comprising a combination of probiotic microorganisms and prebiotic components.
"Preventing" as used herein refers to reducing the likelihood of developing a disorder or symptoms associated with the disorder in a subject in need thereof or particularly at risk of developing the disorder or symptoms. As used herein, "treatment" refers to reducing, alleviating, or completely eliminating symptoms associated with certain conditions that cause pain or discomfort to humans.
"Insomnia" is a common sleep disorder characterized by difficulty falling asleep, difficulty maintaining sleep, or causing the affected subject to wake prematurely and fail to fall asleep again, and unsatisfactory rates of deep sleep or restorative sleep. The induction of pre-sleep relaxation improves sleep quality and duration, helping to increase the overall sensation of getting a rest after sleep. Diagnosis and assessment may be performed by a general practitioner or medical professional for sleep and related conditions.
As used herein, "sleep quality" refers to quantitative aspects of sleep, such as sleep duration, sleep latency or number of awakenings, as well as subjective aspects, such as depth or peace of sleep. Sleep quality may be determined by the Pittsburgh sleep quality index (Pittsburgh Sleep Quality Index) (Buysee et al, "The Pittsburgh Sleep Quality Index: a new instrument for PSYCHIATRIC PRACTICE AND RESEARCH Pittsburgh sleep quality index: new tools for psychiatric practice and research ]". Psych Res [ psychiatric research ],28,193-213.1989).
Herein, improving sleep quality, and/or inducing and/or enhancing pre-sleep relaxation is compared to a human not taking a nutritional composition comprising a and b (i.e., not taking a composition or taking another composition not comprising a and b). Thus, the improvement of a human taking a nutritional composition comprising a and b is increased by ≡2%, preferably ≡5%, more preferably ≡50%, even more preferably ≡65%, compared to a human not taking a nutritional composition comprising a and b (i.e. not taking a composition or taking another composition not comprising a and b). In particular, if the improvement in a human not taking a nutritional composition comprising a and b (or taking another composition not comprising a and b) is M and the improvement compared to a human taking a nutritional composition comprising a and b is N, (N-M)/N x 100% is the percentage of increase thereof.
"Halitosis" (bad breath or bad breath) is a condition characterized by oral malodor and is not necessarily associated with oral and dental diseases. Halitosis may be of intra-oral or extra-oral origin. Extraoral (non-oral) bad breath may be of gastrointestinal origin. The inventors have unexpectedly observed a reduction in bad breath in subjects administered the composition according to the invention. Without wishing to be bound by any theory, it is hypothesized that the composition according to the invention prevents dysbiosis in the gastrointestinal tract, thereby eliminating the extraoral cause of bad breath.
By "skin appearance and texture" is meant an improved skin feel after administration of the composition according to the invention. In particular, the inventors have unexpectedly observed a significant improvement in the appearance of skin and a reduction in the appearance of enlarged skin pores in adults taking the compositions of the present invention.
In some jurisdictions, the present invention is defined as a method of preventing and/or treating insomnia in a human subject, the method comprising administering to the human subject a composition comprising:
a.10 3 to 10 12 colony forming units/g of the composition, the at least one probiotic being selected from the group comprising a Lactobacillus species, a Bifidobacterium species, or a combination thereof, and optionally
B. And 11wt% or more of prebiotic fiber based on the total weight of the composition.
In other jurisdictions, the present invention is defined as the use of a composition in the manufacture of a composition for preventing and/or treating insomnia in a human subject, the composition comprising:
a.10 3 to 10 12 colony forming units/g of the composition, the at least one probiotic being selected from the group comprising a Lactobacillus species, a Bifidobacterium species, or a combination thereof, and optionally
B. And 11wt% or more of prebiotic fiber based on the total weight of the composition.
In a further jurisdiction, the present invention is defined as a non-therapeutic method of preventing and/or treating insomnia in a human subject, the composition comprising:
a.10 3 to 10 12 colony forming units/g of the composition, the at least one probiotic being selected from the group comprising a Lactobacillus species, a Bifidobacterium species, or a combination thereof, and optionally
B. And 11wt% or more of prebiotic fiber based on the total weight of the composition.
Preferably, the prophylaxis and/or treatment is compared to a human not taking a nutritional composition comprising a and b (i.e. not taking a composition or taking another composition not comprising a and b). Thus, a human taking a nutritional composition comprising a and b increases by ≡2%, preferably ≡5%, more preferably ≡50%, even more preferably ≡65% improvement in preventing and/or treating insomnia (including poor sleep quality) compared to a human not taking a nutritional composition comprising a and b (i.e. not taking a composition or taking another composition not comprising a and b). In particular, if the improvement in a human not taking a nutritional composition comprising a and b (or taking another composition not comprising a and b) is M and the improvement compared to a human taking a nutritional composition comprising a and b is N, (N-M)/N x 100% is the percentage of increase thereof.
Probiotics
Preferably, the composition comprises from 10 3 to 10 12 colony forming units per gram of the composition of at least one probiotic, more preferably from 10 4 to 10 10 colony forming units per gram of the composition of at least one probiotic selected from the group comprising Lactobacillus species, bifidobacterium species or combinations thereof.
In one embodiment, the composition comprises from 1wt.% to 20wt.% of the at least one probiotic based on the dry weight of the composition, more preferably from 3wt.% to 15wt.% of the at least one probiotic based on the dry weight of the composition.
In another embodiment, the composition comprises 25-250mg of at least one probiotic per gram of composition, more preferably 50-150mg of at least one probiotic per gram of composition.
The daily dose of at least one probiotic in the composition according to the invention is an amount of 10 3 to 10 12 colony forming units, preferably 10 8 to 10 11 colony forming units.
In a preferred embodiment of the invention, the composition comprises at least one species of the genus Lactobacillus. Preferably the Lactobacillus species present in the composition is selected from the group comprising Lactobacillus paracasei, lactobacillus acidophilus, lactobacillus muriluz, lactobacillus reuteri, lactobacillus rhamnosus or a mixture thereof. Preferably, the probiotic comprises a paracasei subspecies paracasei, more preferably a paracasei subspecies paracasei CRL 431.
The composition may comprise at least one bifidobacterium species. Preferred bifidobacterium species include bifidobacterium adolescentis, bifidobacterium longum subspecies longum (Bifidobacterium longum subsp. Longum), bifidobacterium infantis subspecies, bifidobacterium pseudolongum, bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium animalis subsp. Lactis, bifidobacterium breve, and mixtures thereof. In a preferred embodiment, the bifidobacterium species is bifidobacterium lactis BB12 (deposited with the german collection of microorganisms and cell cultures (Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH, DSMZ) under accession No. DSM 15954, commercially available from hansen company (CHRISTIAN HANSEN company of Denmark) of denmark, under the trademark BB12.
In a particularly preferred embodiment of the invention, the composition comprises at least one lactobacillus species and at least one bifidobacterium species. More preferably, the composition comprises a mixture of a sub-cheese species CRL 431 of lactobacillus paracasei and bifidobacterium lactis BB 12.
Prebiotic fiber
The composition comprises a carbohydrate, including a prebiotic fiber.
Preferably, the composition comprises 11% by weight or more of the prebiotic fibers, more preferably 30% by weight or more, even more preferably 40% by weight or more, and even more preferably 60% to 90% by weight of the prebiotic fibers, based on the total weight of the composition.
Preferably, the total carbohydrate is present in an amount ranging from 40wt.% to 98wt.% by weight of the total composition, more preferably from 50wt.% to 95wt.% by weight of the total composition.
Carbohydrates as used herein include sugars and sugar derivatives, monosaccharides and complex sugars, and sugar-rich components. Preferably, the composition comprises a sugar-rich ingredient, such as honey powder, juice powder, etc., preferably the composition comprises 1wt% to 15wt%, preferably 2wt% to 13wt% honey powder based on the total weight of the composition. The composition may further comprise 1wt% to 10wt% fruit juice powder, more preferably 2wt% to 8wt% fruit juice powder based on the total weight. The preferred fruit juice powder is acerola (acerola) fruit juice powder.
In a preferred embodiment, the composition does not comprise lactose and milk-derived carbohydrates, preferably the composition does not comprise lactose.
Preferred prebiotics are Sialylated Oligosaccharides (SOS), fructo-oligosaccharides (FOS), galacto-oligosaccharides (GOS), isomalto-oligosaccharides (IMO), xylo-oligosaccharides (XOS), arabinoxylans (AXOS), mannooligosaccharides (MOS), soy oligosaccharides, glycosyl Sucrose (GS), lactulose oligosaccharides (LS), sialyllactose (SL), fucosyllactose (FL), lactose-N-neotetraose (LNNT), lactulose (LA), palatinose oligosaccharides (PAO), malto-oligosaccharides, gums and/or hydrolysates thereof, pectins, starches and/or hydrolysates thereof.
The prebiotic fibers are preferably soluble prebiotic fibers. "soluble prebiotic fibers" (also referred to herein as non-digestible fibers) beneficially affect the host by selectively stimulating the growth and/or activity of one or a limited number of bacteria in the colon, thereby improving host health. Such components are non-digestible in that they are not disintegrated and absorbed in the stomach or small intestine and thus enter the colon intact, where they are selectively fermented by beneficial bacteria.
Preferred soluble prebiotic fibers are selected from fructooligosaccharides, inulin, galactooligosaccharides, beta-glucan (preferably yeast or oat beta-glucan, more preferably oat beta-glucan) or combinations thereof. In a particularly preferred embodiment, the composition comprises at least one of inulin, fructooligosaccharides and oat β -glucan, more preferably the composition comprises inulin, fructooligosaccharides and oat β -glucan. Commercially available sources include short chain fructooligosaccharides (e.g., under the trademarkProducts sold) and inulin (e.g. under the trademarkProducts for sale).
In a further aspect, the present invention relates to a composition comprising:
i. at least 40wt.% carbohydrate based on the total composition,
Not less than 85wt.% of prebiotic soluble fiber based on the total weight of carbohydrate,
10 3 To 10 12 colony forming units/g of at least one probiotic of the composition, the at least one probiotic being selected from the group comprising Lactobacillus species, bifidobacterium species or a combination thereof
Wherein the composition does not comprise lactose.
Preferably, the composition comprises 45wt.% to 95wt.% carbohydrate based on the total composition, more preferably 50wt.% to 80wt.%, even more preferably at least 70wt.% carbohydrate.
The composition preferably comprises at least 90wt.% prebiotic soluble fiber, more preferably at least 95wt.% prebiotic soluble fiber, even more preferably at least 98wt.% prebiotic soluble fiber, based on the total weight of carbohydrate.
In preferred embodiments, the composition comprises from 0wt.% to 15wt.% lipid based on the total composition, preferably less than 10wt.% lipid based on the total composition, more preferably less than 5wt.% lipid based on the total composition. In particularly preferred embodiments, the composition is substantially free of lipids, e.g., no added lipids are present in the composition, and only trace amounts of lipids present by other ingredients can be detected.
According to a preferred embodiment, the composition comprises 1% to 15% by weight of honey powder, preferably 2% to 13% by weight of honey powder, based on the total weight of the composition.
The composition may further comprise 1wt% to 10wt% fruit juice powder, more preferably 2wt% to 8wt% fruit juice powder based on the total weight. The preferred fruit juice powder is acerola (acerola) fruit juice powder.
Use and application
It has surprisingly been found that the composition of the present invention significantly improves pre-sleep relaxation, reduces psychological stress, improves mood in the adult to whom the composition is administered. In addition, skin dullness and pore size are improved, and bad breath is significantly reduced.
Preferably, the human subject is selected from infants, adolescents or adults. Thus, the composition according to the invention is for administration to humans older than 3 years, preferably older than 6 years, more preferably older than 12 years, more preferably older than 16 years.
In a particularly preferred embodiment, the human subject is an adult having an age of greater than 18 years, preferably greater than 30 years, more preferably greater than 45 years, even more preferably greater than 55 years.
The composition is preferably administered to a human subject in a fasting state, preferably at least 8 hours, more preferably 10-14 hours space-time abdominal state. For example, the composition may be administered in the morning, for example 8 hours after the last meal or evening meal. Preferably, the composition is administered in a fasting state before 7 o' clock in the morning.
Preferably, the composition is administered once daily. The composition is preferably administered for a period of at least 7 days, more preferably at least 14 days, even more preferably at least 30 days.
The composition of the invention is preferably a powder or a ready-to-drink beverage, preferably a powder. The powder is preferably reconstituted in water or a liquid food product (e.g. warm water). However, the powder is suitable for reconstitution in animal or plant milk, beverages, yoghurt, soups, cereals, warm or cold foods etc. The compositions may also be present in liquid suspensions, tablets, chewing gums, candies, nutritional supplements and the like.
The invention is described herein by the following illustrative, non-limiting examples.
Examples
Example 1
The synbiotic supplement according to the invention can be prepared by dry blending. The compositions are shown in table 1.
TABLE 1
Example 2
A study was performed on healthy volunteers (n=209) comprising the administration of the composition according to example 1 for a period of 14 days. Human volunteers are between 40-60 years of age (average 49 years), with 49% being male participants and 51% female participants.
Prior to the start of the study, volunteers were asked to use questionnaires to evaluate different parameters of their health status. It is recommended that the product according to example 1 be taken in the morning and therefore diluted in water at about 30 ℃ with a minimum of 8 hours on an empty stomach. On days 7 and 14, volunteers were asked to re-evaluate health status. The percentage of study subjects who observed the presence of the given parameters is provided on "day 0". The percentage improvement observed is shown in the columns at day 7 and day 14. The results are shown in table 2 below.
TABLE 2
Claims (23)
1. An enteral composition for use in the prevention and/or treatment of insomnia or sleep disorders in a human subject,
The composition comprises:
a.10 3 to 10 12 colony forming units/g of the composition, the at least one probiotic being selected from the group comprising a Lactobacillus species, a Bifidobacterium species, or a combination thereof, and optionally,
B. And 11wt% or more of prebiotic fiber based on the total weight of the composition.
2. Enteral composition according to claim 1, wherein the daily dose of the at least one probiotic is from 10 3 to 10 12 colony forming units, preferably from 10 8 to 10 11 colony forming units.
3. The enteral composition according to any one of the preceding claims, wherein the composition does not comprise lactose.
4. Enteral composition according to any one of the preceding claims, wherein the composition comprises at least one species of the genus lactobacillus, preferably selected from the group consisting of lactobacillus paracasei, lactobacillus acidophilus, lactobacillus murinus, lactobacillus reuteri, lactobacillus rhamnosus or mixtures thereof.
5. The enteral composition according to any one of the preceding claims, wherein the lactobacillus species is lactobacillus paracasei, preferably lactobacillus paracasei subspecies paracasei, more preferably lactobacillus paracasei subspecies CRL 431.
6. Enteral composition according to any one of the preceding claims, wherein the composition comprises at least one bifidobacterium species, preferably selected from the group consisting of bifidobacterium adolescentis, bifidobacterium longum subspecies longum, bifidobacterium infantis subspecies longum, bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium breve and mixtures thereof.
7. Enteral composition according to any one of the preceding claims, wherein the bifidobacterium species is bifidobacterium lactis, preferably bifidobacterium lactis BB12.
8. Enteral composition according to any one of the preceding claims, wherein the composition comprises lactobacillus species and bifidobacterium species.
9. Enteral composition according to any one of the preceding claims, wherein the prebiotic fiber, preferably the soluble prebiotic fiber, is selected from fructooligosaccharides, inulin, galactooligosaccharides, β -glucan or combinations thereof.
10. The enteral composition according to any one of the preceding claims, wherein the composition is administered to a human subject in a fasting state.
11. The enteral composition according to any one of the preceding claims, wherein the empty stomach is at least 8 hours, preferably 10-14 hours.
12. Enteral composition according to any one of the preceding claims, wherein the human subject is an adult, preferably an adult of > 30 years old.
13. The enteral composition according to any preceding claim, wherein the composition is administered once daily.
14. Enteral composition according to any one of the preceding claims, wherein the composition is administered for a period of at least 7 days, preferably at least 14 days.
15. Enteral composition according to any one of the preceding claims, wherein the composition is a powder, preferably a powder reconstituted in warm water.
16. Enteral composition according to any one of the preceding claims, wherein the prophylactic and/or therapeutic improvement is ≡2%, preferably ≡5%, compared to humans not taking nutritional compositions comprising a and b.
17. A non-therapeutic method of improving sleep quality, and/or inducing and/or enhancing pre-sleep relaxation, the method comprising administering to a human subject in need thereof an enteral composition, wherein the composition comprises:
a.10 3 to 10 12 colony forming units/g of the composition, the at least one probiotic being selected from the group comprising Lactobacillus species, bifidobacterium species or a combination thereof, and
B. And 11wt% or more of prebiotic fiber based on the total weight of the composition.
18. The non-therapeutic method of claim 17, wherein the improvement and/or enhancement is greater than or equal to 2%, preferably greater than or equal to 5% relative to a human not taking the nutritional composition comprising a and b.
19. A non-therapeutic method of reducing halitosis, the method comprising administering to a human subject in need thereof an enteral composition, wherein the composition comprises:
a.10 3 to 10 12 colony forming units/g of the composition, the at least one probiotic being selected from the group comprising Lactobacillus species, bifidobacterium species or a combination thereof, and
B. And 11wt% or more of prebiotic fiber based on the total weight of the composition.
20. A non-therapeutic method of improving the appearance and texture of skin, the method comprising administering to a human subject in need thereof an enteral composition, wherein the composition comprises:
a.10 3 to 10 12 colony forming units/g of the composition, the at least one probiotic being selected from the group comprising Lactobacillus species, bifidobacterium species or a combination thereof, and
B. And 11wt% or more of prebiotic fiber based on the total weight of the composition.
21. An enteral composition comprising at least one compound, the enteral composition comprises:
i. at least 40wt.% carbohydrate based on the total composition,
Not less than 85wt.% of prebiotic soluble fiber based on the total weight of carbohydrate,
10 3 To 10 12 colony forming units/g of at least one probiotic of the composition, the at least one probiotic being selected from the group comprising Lactobacillus species, bifidobacterium species or a combination thereof
Wherein the composition does not comprise lactose.
22. Use of a composition according to any one of claims 1 to 16 in the manufacture of an enteral product for the prevention and/or treatment of insomnia or sleep disorders in a human subject, the composition comprising:
a.10 3 to 10 12 colony forming units/g of the composition, the at least one probiotic being selected from the group comprising a Lactobacillus species, a Bifidobacterium species, or a combination thereof, and optionally,
B. And 11wt% or more of prebiotic fiber based on the total weight of the composition.
23. The use of claim 22, wherein the prophylactic and/or therapeutic improvement is ≡2%, preferably ≡5% compared to humans not taking the composition comprising a and b.
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