Classifications

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  • 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
  • A23L33/105—Plant extracts, their artificial duplicates or their derivatives
• • 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
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  • A61K31/19—Carboxylic acids, e.g. valproic acid
  • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
  • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
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  • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
  • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
  • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
  • A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
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  • A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
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• • A—HUMAN NECESSITIES
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  • A61K36/18—Magnoliophyta (angiosperms)
  • A61K36/185—Magnoliopsida (dicotyledons)
  • A61K36/87—Vitaceae or Ampelidaceae (Vine or Grape family), e.g. wine grapes, muscadine or peppervine
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  • A61K9/2013—Organic compounds, e.g. phospholipids, fats
  • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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  • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
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  • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
  • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
• • A—HUMAN NECESSITIES
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Definitions

• the invention relates to a composition
• a composition comprising at least one mixture of extracts of Vitis vinifero and of Vaccinium angustifolium, and at least one probiotic bacterium and/or probiotic yeast.
• Such a composition is intended for use as a nutritional product or medicine for improving cognitive functions in humans or animals.
• Cognitive decline and the appearance of the first cognitive disorders in particular neurodegenerative diseases such as Alzheimer's disease or Parkinson's disease mainly affects elderly subjects. Due to the evolution of medicine and the quality of care provided, the elderly population is increasing. There is therefore a high prevalence of these age-related pathologies. It is therefore of interest to develop solutions to prevent or minimize age-related cognitive decline and delay the onset of associated pathologies, in particular to prolong the autonomy of the elderly population and thus maintain their quality of life.
• patent FR3042712 describes a mixture of molecules obtained from Vitis vinifera and Vaccinium angustifolium, comprising at least 1% of catechin and/or epicatechin, and at least 5 ppm of ferulic acid.
• Two clinical studies showing the effectiveness of this mixture of molecules have been published (Bensalem J et al. Polyphenols From Grape and Blueberry Improve Episodic Memory in Healthy Elderly with Lower Level of Memory Performance: A Bicentric Double-Blind, Randomized, Placebo-Controlled Clinical Study. J Gerontol A Biol Sci Med Sci. 2019 Jul 19;74(7):996-1007; Hakkinen PJ. Hair.
• intestinal inflammation can promote cognitive deterioration and dementia.
• a decrease in the abundance of anti-inflammatory bacterial species such as Bifidobacterium breve Al strain and an increase in the abundance of pro-inflammatory flora phyla such as Firmicutes and Bacteroidetes are the most significant alterations. distinct from the gut microbiota of patients with Alzheimer's disease.
• Probiotics are live microorganisms which confer a benefit on the health of the host when they are provided in sufficient quantities.
• the prior art teaches us that taking a probiotic can act effectively on the cognitive functions of the animal (Wang H, Lee IS, Braun C, Enck P. Effect of probiotics on central nervous System functions in animals and humans: A systematic review (Vol. 22, Journal of Neurogastroenterology and Motility. Journal of Neurogastroenterology and Motility; 2016. pp. 589-605). It is also known from the prior art that the use of probiotics of the same species or of different species improved the cognitive functions in subjects suffering from mild cognitive disorders or Alzheimer's disease, possibly by reducing the inflammation and oxidative stress (Deng H, et al.
• the present invention provides a new composition comprising at least one mixture of extracts of Vitis vinifero and Vaccinium angustifolium, and at least one probiotic bacterium and/or probiotic yeast.
• Such a composition is not known from the prior art.
• the combination of a mixture of extracts of Vitis vinifero and of Vaccinium angustifolium and of at least one probiotic bacterium and/or probiotic yeast is particularly advantageous.
• Such a combination makes it possible to obtain a synergistic effect in particular prebiotic due to the polyphenols to improve the cognitive functions compared to a mixture of said extract or of a probiotic consumed individually by humans or animals.
• polyphenols are known to have antimicrobial activity.
• the combination of polyphenols provided concomitantly by extracts of Vitis vinifero and of Vaccinium angustifolium do not show such effects on the probiotics of the invention.
• the invention provides a new nutritional or pharmaceutical composition comprising:
• the probiotic bacterium and/or probiotic yeast integrated into the composition according to the invention is preferably chosen from bacteria and/or yeasts of the genus Lactobacillus, Bifidobacterium, Bacillus, Streptococcus, Saccharomyces, Enterococcus, Pediococcus and Escherichia.
• Such a composition is particularly intended to be administered to humans or animals as a medicament for preventing and/or treating pathologies associated with cognitive decline, but also as a nutritional product for preventing and/or treating normal cognitive decline in a healthy subject.
• composition is also intended for healthy subjects without pathologies associated with cognitive decline.
• Another object of the invention therefore relates to a non-therapeutic use of the composition according to the invention in healthy humans or animals, to improve cognitive functions and/or executive functions, and/or to limit normal age-related cognitive decline.
• nutritional composition is meant within the meaning of the invention any mixture of food compounds intended to be ingested by a healthy subject and comprising a mixture of extracts of Vitis vinifero and Vaccinium angustifolium and at least one probiotic bacterium and/or probiotic yeast.
• the nutritional compositions are in particular food or food compositions, or food supplements.
• health subject in the sense of the invention a subject who may be a human or an animal not suffering from any pathology associated with pathological cognitive decline such as Alzheimer's disease, Parkinson's disease , Huntington's disease, motor neuron disease or age-related macular degeneration (AMD).
• pathology associated with pathological cognitive decline such as Alzheimer's disease, Parkinson's disease , Huntington's disease, motor neuron disease or age-related macular degeneration (AMD).
• pathological subject is understood to mean, within the meaning of the invention, a subject who suffers or is likely to suffer from pathological cognitive decline such as Alzheimer's disease, Parkinson's disease, of Huntington's disease, motor neuron disease or age-related macular degeneration (AMD).
• pathological cognitive decline such as Alzheimer's disease, Parkinson's disease, of Huntington's disease, motor neuron disease or age-related macular degeneration (AMD).
• composition comprising at least one active substance presented as having curative or preventive properties with regard to human or animal diseases used alone or combined with other active or non-active substances and intended to be ingested by a pathological subject.
• a composition comprises in particular a mixture of extracts of Vitis vinifero and of Vaccinium angustifolium and at least one probiotic bacterium and/or probiotic yeast.
• the pharmaceutical composition is therefore a medicament intended for humans or animals in the prevention and/or treatment of pathological cognitive decline such as Alzheimer's disease, Parkinson's disease, Huntington's disease, motor neuron or age-related macular degeneration (AMD).
• pathological cognitive decline such as Alzheimer's disease, Parkinson's disease, Huntington's disease, motor neuron or age-related macular degeneration (AMD).
• a mixture of extracts of Vitis vinifero and Vaccinium angustifolium is meant a set of molecules obtained from a mixture of Vitis vinifero and Vaccinium angustifolium, preferably a mixture of at least one extract of Vitis vinifero and at least one extract of Vaccinium angustifolium.
• the raw material of Vitis vinifero can be the leaves and/or the fruits and/or the pips and/the woods, preferentially the raw material of Vitis vinifero is the aerial part of the plant, that is to say the whole leaves, fruits, skin (skin), seeds and wood, more preferably the skin (skin) and seeds.
• the raw material of Vaccinium angustifolium can be the leaves and/or the fruits, preferentially the raw material of Vaccinium angustifolium is all the leaves and fruits of the plant.
• At least X% of catechins and/or epicatechins is meant either at least X% of catechins if there are no epicatechins in the mixture, or at least X% of epicatechins there are no catechins in the mixture, i.e. at least X% of the mixture of catechins and epicatechins if both catechins and epicatechins are present in the mixture.
• at least X% of the mixture of catechins and epicatechins is meant.
• ppm is meant parts per million (mg/kg) in the mixture. Unless otherwise stated, ppm refers to a weight based on the total weight of the mixture.
• prevention within the meaning of the invention, is meant the reduction to a lesser degree of the risk or the probability of occurrence of a given phenomenon, that is to say, in the context of the present invention, for example, a pathological cognitive disorder.
• treating or “treatment” within the meaning of the invention, is meant a reduction in the progression of the disease or disorder, a stabilization, a reversal or regression, or even an interruption or inhibition of the progression of a disease or disorder. In the context of the invention, these terms also apply to one or more symptoms of said diseases or disorders of the present invention.
• the objective of the invention is therefore to provide a composition having improved efficacy in the fight against cognitive decline.
• the subject of the present invention is therefore a nutritional or pharmaceutical composition
• a nutritional or pharmaceutical composition comprising:
• the extract according to the invention can be obtained by any method making it possible to obtain a mixture of extracts of Vitis vinifero and of Vaccinium angustifolium and will be detailed below in this description.
• the mixture of extracts comprises a mixture of molecules comprising:
• Catechins and epicatechins are compounds of the flavonoid family, in particular of the flavanol subclass. They are also known as catechol and epicatechol and are powerful antioxidants that help in particular to prevent inflammatory and coronary diseases but also to maintain or increase cognitive performance.
• Ferulic acid is known for its effects on the neuronal system, in particular to protect neuronal cells from cell death induced by cerebral ischemia (Cheng SY, et al. Ferulic acid provides neuroprotection against oxidative stress-related apoptosis after cerebral ischemia/reperfusion injury by inhibiting ICAM-1 mRNA expression in rats (Brain Res. 2008;1209:136-150). In addition, its antioxidant activity has been tested in Alzheimer's disease (Sgarbossa A, et al. Ferulic Acid: A Hope for Alzheimer's Disease Therapy from Plants. Nutrients.
• composition is particularly increased and effective when it also comprises: - at least 200 ppm resveratrol, and/or
• Resveratrol is particularly known to be present in grapes. However, it can also be derived from other plant sources, in particular from Polygonum cuspidatum but also by biotechnological means. It has many beneficial activities for humans or animals, including an improvement in working memory, learning, spatial memory and spontaneous motor activity (Abraham J, Johnson RW. Consuming a diet supplemented with resveratrol reduced infection-related neuroinflammation and deficits in working memory in aged mice.Rejuvenation Res [Internet] 2010/01/01.2009;12(6):445-53).
• Quercetin also has significant neuroprotective activity (Dajas F, et al. Neuroprotective actions of flavones and flavonols: mechanisms and relationship to flavonoid structural features. Cent Nerv Syst Agents Med Chem. 2013; 13(l):30-5 ).
• composition according to the invention comprises at least one probiotic bacterium and/or probiotic yeast combined with the mixture of extracts.
• the specific combination as well as the quantity of the molecules found in the present composition makes it possible to obtain an effect on cognitive decline in humans or animals, this effect being better than that of an extract of Vitis vinifera and of Vaccinium angustifolium alone or of at least one probiotic bacterium and/or probiotic yeast alone.
• the probiotic bacterium and/or probiotic yeast can be dead, inactivated, semi-inactivated or alive.
• Said bacterium and/or probiotic yeast preferentially belongs to the genus Lactobacillus, Bifidobacterium, Bacillus, Streptococcus, Saccharomyces, Enterococcus, Clostridium, Lactococcus and Escherichia.
• the mixture, the probiotic bacteria and/or yeast is chosen from bacteria and/or yeast of the genus Lactobacillus, Bifidobacterium, Streptococcus, Enterococcus and Lactococcus.
• the bacterium is chosen from bacteria of the following species: Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus acidophilus, Lactobacillus bulgaricus, Lactobacillus delbrueckii ssp delbrueckii, Lactobacillus casei, Lactobacillus casei Shirota, Lactobacillus curvatus, Lactobacillus brevis, Lactobacillus fermentum, Lactobacillus salivarius, Lactobacillus mucosae, Lactobacillus paracasei, Lactobacillus johnsonii, Lactobacillus pentosus, Lactobacillus helveticus, Bifidobacterium bifidum, Bifidobacterium infantis, Bifidobacterium lactis, Bifidobacterium longum, Bifidobacterium longum spp infantis, Bifidobacterium longum
• the yeast is chosen from yeasts of the following species: Saccharomyces cerevisiae, Saccharomyces boulardii and their mixture.
• the composition according to the invention provides between 1 ⁇ 10 5 and 9 ⁇ 10 12 CFU daily, preferably between 1 ⁇ 10 7 and 9 ⁇ 10 11 of a probiotic bacterium and/or yeast and/or of a mixture.
• the composition may also comprise at least one prebiotic chosen from inulin, oligosaccharides, FOS (fructo-oligosaccharides), GOS (galacto-oligosaccharides), CLA (conjugated linoleic acid), PUFA (polyunsaturated fatty acid), MOS (mannanoligosaccharide) and XOS (xylooligosaccharide).
• prebiotic chosen from inulin, oligosaccharides, FOS (fructo-oligosaccharides), GOS (galacto-oligosaccharides), CLA (conjugated linoleic acid), PUFA (polyunsaturated fatty acid), MOS (mannanoligosaccharide) and XOS (xylooligosaccharide).
• prebiotic makes it possible to reinforce the effectiveness of the composition.
• the composition exhibits an improved effect in the prevention and/or treatment of cognitive decline.
• the composition can be encapsulated or microencapsulated, preferably the composition is encapsulated or microencapsulated in a food carrier chosen from maltodextrin, gum arabic, hydrogenated or non-hydrogenated oil, wax, alginates, starch, hydrolyzed or non-hydrolyzed proteins, phosphatidylcholine, phospholipids, galactomannan, emulsifiers chosen from pectin or polyglycerol polyricinoleate and fibers chosen from polydextrose, HPMC and cellulose.
• Encapsulation is particularly advantageous and makes it possible to stabilize and protect the extract of Vitis vinifero and of Vaccinium angustifolium and/or the probiotic(s) (bacteria and/or yeasts) from its environment, in particular from the organism.
• encapsulation makes it possible to improve the stability, the bioavailability and the use of said extract in food matrices, with in particular masking of the taste and resistance to possible alterations of the compounds during the stages of production of a food product.
• Microencapsulation provides the same advantages as encapsulation but more particularly makes it possible to insert active substances within particles of size between 1 ⁇ m and 1000 ⁇ m and more preferentially between 30 ⁇ m and 500 ⁇ m and even more preferentially between 50pm and 300pm.
• composition according to the invention is intended to be administered as a nutritional or therapeutic product and can therefore be in different forms, preferably in the form of a powder, capsule, tablet, capsule, solution, suspension, emulsion or chewing gum.
• composition When the composition is intended to be administered as a nutritional product, it may be in the form of a food product, preferably in the form of dairy products, purees, cereals, cereal products and beverages.
• the invention When the composition is administered as a therapeutic product, the invention relates to a composition for its use as a medicament for humans or animals.
• Cognitive decline is characterized by an age-related decrease in cognitive and executive functions, in particular concentration, working memory, long-term memory, reasoning, judgment, resolution problems and information processing speed. These deficiencies can lead to a decrease in self-esteem and quality of life.
• Age-related cognitive decline is the term used to describe the non-pathological form of deterioration of memory and cognitive functions consequent to the aging process within normal limits, given a person's age. It is a complex process, with the first signs emerging in humans between 35 and 65 years old, without specific neurodegenerative lesions. Progressive cognitive decline is noticeable by the appearance of minor cognitive problems which affect 15-20% of the population aged 65 or over, but which represent an unstable state. Nevertheless, certain pathological forms may occur in addition to this “normal” cognitive decline.
• Alzheimer's disease is the most common cause of dementia, which affects more than 24 million people worldwide. It is irreversible in our current state of knowledge, the only treatments available being purely symptomatic. In animals, these pathologies can present themselves in a very similar way.
• the cognitive dysfunction syndrome (or CDS) is a widespread pathology characterized by spatio-temporal disorientation, a loss of elementary learning which often induces uncleanliness, an alteration of sleep-wake cycles, and impaired social interactions.
• the composition is intended for use in neuroprotection, and/or improving cognitive functions and/or memory and/or executive functions, and/or alleviating cognitive decline.
• the composition according to the invention exhibits neuroprotective effects and can be used in the prevention and/or treatment of pathologies associated with cognitive decline.
• composition according to the invention can be used in the prevention and/or treatment of pathologies associated with the destruction of neurons, the decrease in cognitive functions, memory, executive functions.
• composition according to the invention is particularly intended for use in the prevention and/or treatment:
• neurodegenerative diseases such as Alzheimer's disease, and/or Parkinson's disease, and/or Huntington's disease, and/or motor neuron diseases and/or age-related macular degeneration (AMD),
• AMD age-related macular degeneration
• CDS mental retardation and/or cognitive dysfunction syndrome
• composition according to the invention is delivered at a dose making it possible to provide humans or animals with:
• composition according to the invention is delivered at a dose making it possible to provide humans or animals with:
• animal may also be a nutritional or therapeutic composition intended for the animal.
• the term “animal” is understood to mean any animal that can receive a nutritional or therapeutic composition according to the invention, for example but in a non-limiting way a pet, a poultry, a pig, a ruminant, a goat, or even a mouse.
• the animal is a pet, such as a cat or a dog. More preferably, the animal is a dog.
• composition according to the invention is also intended to be used as a nutritive product without any therapeutic effect and in a healthy subject.
• the invention also relates to a non-therapeutic use of the composition according to the invention in healthy humans or animals, to improve cognitive functions and/or executive functions, and/or to limit normal age-related cognitive decline.
• the invention relates to a non-therapeutic use of the composition for improving memory and/or attention and/or concentration and/or alertness and/or alertness and/or learning and/or intelligence and/or language and/or mood and/or stress and/or anxiety and/or sleep.
• composition according to the invention in the context of a non-therapeutic use can preferably be delivered in an amount making it possible to provide healthy humans or animals:
• composition according to the invention is delivered in an amount making it possible to provide healthy humans or animals with:
• quercetin and/or quercetin glycosides at least 0.2 pg per kg of body weight of quercetin and/or quercetin glycosides
• ferulic acid preferably at least 10 ppm, even more preferably between 5 and 300 ppm, in particular between 10 and 100 ppm.
• the process makes it possible to obtain a mixture of molecules comprising:
• quercetin and/or quercetin glycosides at least 50 ppm of quercetin and/or quercetin glycosides, 70 ppm of quercetin and/or glycoside, in particular between 50 and 100 ppm, and
• anthocyanidins preferably at least 600 ppm, even more preferably at least 700 ppm.
• a particularly suitable method is a method comprising the following steps:
• an extract of Vitis vinifera a. water and/or ethanol extraction of Vitis vinifera, preferably of all the leaves, fruits, skin, pips and wood of Vitis vinifera.
• the quantity of solvent (30% v/v to 96% V/V) used is between 2 and 10 times the mass of material used.
• the duration of the extraction can be between 30 minutes and 24 hours and the extraction temperature between 20°C and 80°C.
• the raw materials used can be in dry, fresh, or frozen whole or ground form; b. separation of the water and/or ethanol solution from the solid material, for example by centrifugal decantation or by pressing and filtration; vs. evaporation of the ethanol by vacuum evaporation at a temperature preferably below 60° C.
• d membrane separation of the previously desolventized extract so as to preferentially select the proanthocyanidin monomers and oligomers (having a degree of polymerization between 2 and 10 inclusive) and to eliminate the flavanol polymers (> decamers), to obtain an extract comprising at least 1% of catechins and/or epicatechins.
• This step can be carried out using a filtration membrane having a cut-off threshold of less than 15,000 daltons and more preferably less than 3,000 daltons;
• an extract of Vaccinium angustifolium a. water and/or ethanol extraction of Vaccinium angustifolium, preferably all of the leaves and fruits of Vaccinium angustifolium,
• the amount of solvent (30% v/v to 96% V/V) used is between 2 and 10 times the mass of material used.
• the duration of the extraction can be between 30 minutes and 24 hours and the extraction temperature between 20°C and 80°C.
• the raw materials used can be in dry, fresh or frozen form; b. separation of the water and/or ethanol solution from the solid material by centrifugal decantation or by pressing and filtration; vs. evaporation of the ethanol by vacuum evaporation at a temperature preferably below 60° C. and a pressure below 100 mbar; d. drying of the extracts by atomization, vacuum drying or lyophilization with or without a support such as a maltodextrin;
• the method consists of the implementation of the following steps:
• the amount of solvent (30% v/v at 96% V/V) implementation is between 2 and 10 times the mass of material implemented.
• the duration of the extraction can be between 30 minutes and 24 hours and the extraction temperature between 20°C and 80°C.
• the raw materials used can be in dry, fresh or frozen form;
• the method may comprise the following steps:
• Example 1 Nutritional composition intended for humans [0083]
• Example 1 is a 400 mg capsule, consisting of:
• Blend of extracts 300 mg
• Blend of 6 probiotics (Lactobacillus fermentum, L plantarum, L acidophilus, Bfidobacterium lactis, B. longum, B. bifidum) 3c10 L 9 CFU: 50 mg Maltodextrin: 50 mg.
• composition is obtained by mixing the constituents under the conventional conditions known to those skilled in the art, and placed in a capsule according to the conventional conditions as well.
• the recommended dosage is 2 capsules per day.
• Example 2 Nutritional composition intended for humans [0085]
• Example 2 is a sachet of 3200 mg, consisting of:
• Blend of extracts 600 mg
• Blend of 3 probiotics (Lactobacillus acidophilus, Bifidobacterium bifidum, Lactobacillus fermentum) 4c10 L 9 CFU: 2500 mg Maltodextrin: 100 mg.
• the composition is obtained by mixing the constituents under conventional conditions known to those skilled in the art and is in the form of a powder contained in a sachet also under conventional conditions. The recommended dosage is 1 sachet per day.
• Example 3 Nutritional composition intended for animals
• Example B is a soft capsule consisting of:
• Blend of extracts 50 mg
• composition is obtained by mixing the constituents under conventional conditions known to those skilled in the art and is in the form of a soft capsule also under conventional conditions.
• the recommended dosage is 1 capsule per day.
• Example 4 Nutritional Composition Intended for Animals
• Example 4 is a tablet consisting of:
• Blend of extracts 50 mg
• Blend of 5 probiotics (Lactobacillus acidophilus, L. plantarum, L. Brevis, Bifidobacterium animalis lactis, Lactobacillus ramnosus) 2c10 L 9 CFU: 26.5 mg
• composition is obtained by mixing the constituents under conventional conditions known to those skilled in the art and is in the form of a tablet also under conventional conditions.
• the recommended dosage is 1 tablet per day for a 10 kg dog.

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