EP4539687A1 - Compositions et leurs utilisations - Google Patents
Compositions et leurs utilisationsInfo
- Publication number
- EP4539687A1 EP4539687A1 EP23822959.5A EP23822959A EP4539687A1 EP 4539687 A1 EP4539687 A1 EP 4539687A1 EP 23822959 A EP23822959 A EP 23822959A EP 4539687 A1 EP4539687 A1 EP 4539687A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- composition
- ssp
- bifidobacterium
- enteral
- composition according
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/20—Hypnotics; Sedatives
Definitions
- the present invention relates to compositions for preventing or treating insomnia, improving skin appearance, reducing halitosis and increasing relaxation towards sleep, improving sleep quality.
- the amount of sleep hours varies per person. For most adults, seven to eight hours per night is considered necessary. As aging occurs, internal sleep clock starts to lose consistency. Older adults thus tend to become tired earlier in the evening and wake up earlier in the morning, resulting in less sleep overall and increasing the risk of cognitive decline. Elderly people experiencing Alzheimer’s , dementia, or other neu-rodegenerative diseases experience even more severe changes in sleep drive.
- insomnia An increasing part of the adult population will, at some point in life, experience short-term, acute insomnia which lasts for days or weeks. This is usually the result of a stressful or a traumatic event. However, some people suffer from long-term, chronic insomnia, wherein insomnia itself may be the primary problem, or it may be associ-ated with other medical conditions or medications.
- CN104187613 discloses a nutritional recipe for insomnia comprising Chinese medicines, probiotics, water soluble prebiotic fibres, etc.
- CN107496850 discloses a preparation for regulating intestinal microecology with ginseng to calm the verse, and then to help on enhancing sleep.
- CN107874251 disclosed a chili probiotic composition
- a chili probiotic composition comprising 1-9 parts of Chinese herbal extract, 0.01-2 parts of food grade probiotics and 0.1-5 parts of prebiotics.
- the present invention relates to a composition for use in preventing and/or treating insomnia in a human subject, the composition comprising:
- composition of at least a probiotic bacteria selected from the group comprising: Lacticaseibacil-lus ssp., Bifidobacterium ssp., or combinations thereof; and, optionally,
- 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 administration of a composition to a human subject in need thereof, wherein the composition comprises:
- composition of at least a probiotic bacteria selected from the group comprising: Lacticaseibacil-lus ssp., Bifidobacterium ssp., or combinations thereof; and optionally
- induction and/or enhancement of pre-sleep relaxation is in comparison with a human subject not administered with the composition according to the invention. It can be determined by individual perception as assessed by specialized questionnaire (including digital) , or by psychological and mental care professional.
- the inventors surprisingly observed remarkable improvements in skin appearance and condition, and reduced halitosis.
- the present invention relates to a non-therapeutic method of reducing halitosis, the method comprising administration of a composition to a human subject in need thereof, wherein the composition comprises:
- composition of at least a probiotic bacteria selected from the group comprising: Lacticaseibacil-lus ssp., Bifidobacterium ssp., or combinations thereof; and optionally
- Halitosis reduction is herein defined in comparison with a subject not administered with the composition according to the invention. It can be determined by individual perception as assessed by specialized questionnaire, or by dental care professional.
- the present invention relates to a non-therapeutic method of improving skin appearance and texture, the method comprising administration of a composition to a human subject in need thereof, wherein the composition comprises:
- composition of at least a probiotic bacteria selected from the group comprising: Lacticaseibacil-lus ssp., Bifidobacterium ssp., or combinations thereof; and optionally
- Improvement in skin appearance and texture is herein defined in comparison with a subject not administered with the composition according to the invention. It can be determined by individual perception as assessed by specialized questionnaire, or by skin care professional such as aesthetician.
- the present invention relates to a composition
- a composition comprising:
- composition of at least a probiotic bacteria selected from the group comprising: Lacticaseibacillus ssp., Bifidobacterium ssp., or combinations thereof
- composition does not comprise lactose.
- the composition is preferably a synbiotic composition.
- the composition is an enteral composition, preferably an oral composition.
- Probiotic means microbial cell preparations or components of microbial cells with a beneficial effect on the health or well-being of the host. (Salminen S, Ouwehand A. Benno Y. et al "Probiotics: how should they be defined” Trends Food ScL Technol. 1999: 10 107-10) .
- “Synbiotic” as used herein refers to a composition comprising a combination of probiotic microorganisms and prebiotic components.
- Prevention refers to reduction in the likelihood of developing a certain condition or symptom associated with a condition in subjects in need thereof or particularly at risk of developing said symptoms and conditions.
- Treatment refers to the reduction, alleviation or complete removal of symptoms associated with certain conditions causing human suffering or discomfort.
- “Insomnia” is a common sleep disorder characterized by the difficulty in falling asleep, staying asleep, or causing the affected subject to wake up too early and not be able to get back to sleep, and unsatisfactory proportion of deep or restorative sleep. Induction of pre-sleep relaxation increases quality and duration of sleep, helping to increase the overall sensation of feeling rested after sleep. It can be diagnosed and assessed by general practitioner or medical specialist in sleep and correlate conditions.
- sleep quality refers to quantitative aspects of sleep, such as sleep duration, sleep latency, or number of arousals, as well as subjective aspects, such as depth or restfulness of sleep. Sleep quality can be determined by Pittsburgh Sleep Quality Index (Buysee et al. “The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research” . Psych Res, 28, 193-213.1989) .
- improving sleep quality and/or induction and/or enhancement of pre-sleep relaxation is in comparison to a human taking no nutritional composition comprising a and b (i.e., no composition or taking another composition not comprising a and b) .
- the improvement in the human taking the nutritional composition comprising a and b increases ⁇ 2%, preferably ⁇ 5%, more preferably ⁇ 50%, even more preferably ⁇ 65%.
- “Skin appearance and texture” refers to the improved perception of skin upon consumption of the composition according to the invention. Particularly, the inventors have surprisingly observed that adults who consumed the composition of the invention claimed a significant improvement on the skin appearance and reduction of large skin pores.
- composition of at least a probiotic bacteria selected from the group comprising: Lacticaseibacil-lus ssp., Bifidobacterium ssp., or combinations thereof; and optionally
- 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:
- composition of at least a probiotic bacteria selected from the group comprising: Lacticaseibacil-lus ssp., Bifidobacterium ssp., or combinations thereof; and optionally
- the present invention is defined as the non-therapeutic method of preventing and/or treating insomnia in a human subject, the composition comprising:
- composition of at least a probiotic bacteria selected from the group comprising: Lacticaseibacil-lus ssp., Bifidobacterium ssp., or combinations thereof; and optionally
- prevention and/or treatment is in comparison to a human taking no nutritional composition comprising a and b (i.e., no composition or taking another composition not comprising a and b) .
- the improvement to preventing and/or treating insomnia (including poor sleep) in the human taking the nutritional composition comprising a and b increases ⁇ 2%, preferably ⁇ 5%, more preferably ⁇ 50%, even more preferably ⁇ 65%.
- the composition comprises 10 3 to 10 12 colony forming units per gram of composition of at least a probiotic bacteria, more preferably 10 4 to 10 10 colony forming units per gram of composition of at least a probiotic bacteria selected from the group comprising: Lacticaseibacillus ssp., Bifidobacterium ssp., or combinations thereof.
- the composition comprises 1-20 wt. %of at least a probiotic bacteria, based on dry weight of the composition, more preferably 3-15 wt. %of at least a probiotic bacteria, based on dry weight of the composition.
- the composition comprises 25-250 mg of at least a probiotic bacteria per gram of the composition, more preferably 50-150 mg of at least a probiotic bacteria per gram of the composition.
- the daily dose of the at least one probiotic bacteria in the composition according to the invention in an amount from 10 3 to 10 12 colony forming units, preferably 10 8 to 10 11 colony forming units.
- the composition comprises at least one species of Lacticaseibacillus ssp.
- Lacticaseibacillus ssp present in the composition is selected from the group comprising: Lacticaseibacillus paracasei, Lacticaseibacillus acidophillus, Lacticaseibacillus murinus, Lacticaseibacillus reuteri, Lacticaseibacillus rhamnosus, or mixtures thereof.
- the probiotic bacteria comprises Lacticaseibacillus paracasei subsp. paracasei, more preferably Lacticaseibacillus paracaseisubsp. paracasei CRL 431.
- the composition may comprise at least one species of Bifidobacterium ssp.
- Bifidobacterium ssp Preferred species of Bifidobacterium ssp. Include: Bifidobacterium adolescentis, Bifidobacterium longum subsp. longum, Bifidobacterium subsp. infantis, Bifidobacterium pseudolongum, Bifidobacterium bifidum, Bifidobacterium lactis, Bifidobacterium animalis subsp. lactis, Bifidobacterium breve, and mixtures thereof.
- the Bifidobacterium ssp. is Bifidobacterium lactis BB12 (as deposited at Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH (DSMZ) under deposit number DSM 15954) , commercially available by Christian Hansen company of Denmark under the trade mark Bb12.
- the composition comprises at least one species of Lactobacillus ssp. and one species of Bifidobacterium ssp. More preferably, the composition comprises a mixture of Lacticaseibacillus paracasei subsp. paracasei CRL 431 and Bifidobacterium lactis BB12.
- the composition comprises carbohydrates, including the prebiotic fibres.
- the composition comprises ⁇ 11 wt%of prebiotic fibres, more preferably ⁇ 30 wt%, even more preferably ⁇ 40 wt%, especially more preferably 60-90 wt%of prebiotic fibre based on total weight of the composition.
- total carbohydrates are present in an amount ranging from 40 –98 wt. %by weight of total composition, more preferably 50-95 wt. %by weight of total composition.
- Carbohydrates used herein include sugars and sugar derivatives, simple and complex sugars, and sugar-rich ingredients.
- the composition comprises sugar-rich ingredients such as honey powder, juice powder, etc.
- the composition comprises 1-15wt%, preferably 2-13wt%of honey powder, based on total weight of the composition.
- the composition may further comprise 1-10wt%juice powder, more preferably 2-8wt%of a juice powder, based on total weight.
- a preferred juice powder is acerola juice powder.
- the composition does not comprise lactose and milk-derived carbohydrates, preferably the composition does not comprise lactose.
- Preferred prebiotics are sialo-oligosaccharides (SOS) , fructo-oligosaccharides (FOS) , galacto-oligosaccharides (GOS) , isomalto-oligosaccharides (IMO) , xylo-oligosaccharides (XOS) , arabino-xylo oligosaccharides (AXOS) , mannan oligosaccharides (MOS) , oligosaccharides of soy, glycosylsucrose (GS) , lactosucrose (LS) , sialyl-lactose (SL) Fucosyl-lactose (FL) , Lacto-N-Neotetraose (LNNT) , lactulose (LA) , palatinose-oligosaccharides (PAO) , malto-oligosaccharides, gums and/or hydrolysates thereof, pec
- the prebiotic fibres are preferably soluble prebiotic fibres.
- “Soluble prebiotic fibres” herein also referred to non-digestible fibres, are beneficially affect the host by selectively stimulating the growth and/or activity of one or a limited number of bacteria in the colon, and thus improving host health.
- Such ingredients are non-digestible in the sense that they are not broken down and absorbed in the stomach or small intestine and thus pass intact to the colon where they are selectively fermented by the beneficial bacteria.
- Preferred soluble prebiotic fibres are selected from fructooligasaccharides, inulin, galactooligasacharides, ⁇ -glucans (preferably yeast or oat ⁇ -glucans, more prefera-bly oat ⁇ -glucans) , or combinations thereof.
- the composition comprises at least one of inulin, fructooligasaccharides and oat ⁇ -glucans, more preferably the composition comprises inulin, fructooligasaccharides and oat ⁇ -glucans.
- Commercially available sources include short chain fructo-oligosaccharides such as the product sold under the trade mark and inu-lin such as the product sold under the trade mark
- the invention relates to a composition
- a composition comprising:
- composition of at least a probiotic bacteria selected from the group comprising: Lacticaseibacillus ssp., Bifidobacterium ssp., or combinations thereof
- composition does not comprise lactose.
- the composition comprises 45-95 wt. %carbohydrates, more preferably 50-80 wt. %, even more preferably at least 70 wt. %carbohydrates based on total composition.
- the composition preferably comprises at least 90 wt. %prebiotic soluble fibres, more preferably at least 95 wt. %prebiotic sol-uble fibres, even more preferably at least 98 wt. %prebiotic soluble fibres.
- the composition comprises 0-15 wt. %lipids, based on total composition, preferably less than 10 wt. %lipids based on total composition, more preferably less than 5 wt. %lipids based on total composition.
- the composition is substantially free of lipids, for instance, no added lipids is present in the composition and only trace amounts present via other ingredients could be detectable.
- the composition comprises honey powder 1-15wt%, preferably 2-13wt%of honey powder, based on total weight of the composi-tion.
- the composition may further comprise 1-10wt%juice powder, more preferably 2-8wt%of a juice powder, based on total weight.
- a preferred juice powder is acerola juice powder.
- composition of the invention has been surprisingly found to significantly improve pre-sleep relaxation, reduce psychological stress, improve mood in adults subjected to administration of the composition. Also, skin dullness and pore size were im-proved, as well as a noticeable reduction on halitosis.
- the human subject is selected from a toddler, adolescent or adult.
- the composition according to the invention is for administration in a human older than 3 years of age, preferably older than 6 years of age, more preferably older than 12 years of age, more preferably older than 16 years of age.
- the human subject is an adult older than 18 years of age, preferably older than 30 years of age, more preferably older than 45 years of age, even more preferably older than 55 years of age.
- the composition is preferably administered to the human subject in a fasting state, preferably a fasting state of at least 8 hours, more preferably 10-14 hours.
- the composition can be administered in the morning, e.g. after 8 hours of the last meal or dinner.
- the composition is administered before 7 am in a fasting state.
- the composition is to be administered once a day.
- 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 bever-age, preferably a powder.
- the powder is preferably reconstituted in water or liquid foods, for instance, warm water.
- the powder is suitable for reconstitution in animal or vegetable milk, beverages, yoghurt, soup, cereals, warm or cold food, and the like.
- the composition may also be presented as a liquid suspension, a tablet, gum, candy, nutritional supplement, and the like.
- a synbiotic supplement according to the invention can be prepared by dry-blending.
- the composition is shown in Table 1.
- the human volunteers were aged between 40-60 years old (mean of 49 years) wherein 49%were male and 51%were female participants.
- Example 2 Before start of the study, the volunteers were asked to assess different parameters of their health status using a questionnaire.
- the product according to Example 1 was recommended to be consumed in the morning, thus with a minimum of 8 hours fasting, diluted in water at around 30 °C.
- the volunteers were asked to reassess the healthy status.
- the percentage of the studied subjects indicating to observe the present of a given parameter is provided in ‘Day 0’ .
- the percentage of observed improvement is indicated in col. Day 7 and day 14.
- the results are shown in table 2 below.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Mycology (AREA)
- Engineering & Computer Science (AREA)
- Microbiology (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Epidemiology (AREA)
- Molecular Biology (AREA)
- Anesthesiology (AREA)
- Neurosurgery (AREA)
- Nutrition Science (AREA)
- Food Science & Technology (AREA)
- Polymers & Plastics (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Dermatology (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Coloring Foods And Improving Nutritive Qualities (AREA)
Abstract
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2022099108 | 2022-06-16 | ||
| PCT/CN2023/098264 WO2023241390A1 (fr) | 2022-06-16 | 2023-06-05 | Compositions et leurs utilisations |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| EP4539687A1 true EP4539687A1 (fr) | 2025-04-23 |
| EP4539687A4 EP4539687A4 (fr) | 2026-02-25 |
Family
ID=89192112
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP23822959.5A Pending EP4539687A4 (fr) | 2022-06-16 | 2023-06-05 | Compositions et leurs utilisations |
Country Status (5)
| Country | Link |
|---|---|
| EP (1) | EP4539687A4 (fr) |
| JP (1) | JP2025520453A (fr) |
| CN (1) | CN119584873A (fr) |
| AU (1) | AU2023293647A1 (fr) |
| WO (1) | WO2023241390A1 (fr) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN119931882B (zh) * | 2025-01-23 | 2025-10-28 | 广州百芮医疗科技有限公司 | 一种提升睡眠质量的乳酸菌菌株组合物及应用 |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AUPO430496A0 (en) * | 1996-12-19 | 1997-01-23 | Arnott's Biscuits Limited | Prebiotics and probiotics |
| EP1865795A1 (fr) * | 2005-04-08 | 2007-12-19 | Alimentary Health Limited | Methodes d'utilisation de bifidobacteries probiotiques administrees par voie orale dans un but cosmetique |
| CN101095698B (zh) * | 2006-06-26 | 2010-12-01 | 青岛东海药业有限公司 | 酪酸梭菌防治便臭毒素引起的相关症状和疾病的用途 |
| AU2014221272B2 (en) * | 2008-11-03 | 2016-01-21 | Société des Produits Nestlé S.A. | A nutritional composition comprising probiotics and improving sleep patterns |
| CN106860483A (zh) * | 2017-01-06 | 2017-06-20 | 家家乐购(北京)科技有限公司 | 含有双歧杆菌和嗜酸乳杆菌的益生菌复合组合物及应用 |
| CN108244655A (zh) * | 2018-02-02 | 2018-07-06 | 云南中京国建投资有限公司 | 一种安神、抗抑郁的合生元组合物及其制剂与应用 |
| CN108671135B (zh) * | 2018-08-01 | 2021-06-08 | 山东神农医院管理有限公司 | 一种调理失眠和抑郁的中药益生菌复合物 |
| CN110051003A (zh) * | 2019-04-24 | 2019-07-26 | 广州能靓生物技术有限公司 | 一种复合益生菌组合物及其应用 |
-
2023
- 2023-06-05 WO PCT/CN2023/098264 patent/WO2023241390A1/fr not_active Ceased
- 2023-06-05 EP EP23822959.5A patent/EP4539687A4/fr active Pending
- 2023-06-05 AU AU2023293647A patent/AU2023293647A1/en active Pending
- 2023-06-05 CN CN202380052128.XA patent/CN119584873A/zh active Pending
- 2023-06-05 JP JP2024573542A patent/JP2025520453A/ja active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| WO2023241390A1 (fr) | 2023-12-21 |
| JP2025520453A (ja) | 2025-07-03 |
| AU2023293647A1 (en) | 2025-01-23 |
| EP4539687A4 (fr) | 2026-02-25 |
| CN119584873A (zh) | 2025-03-07 |
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