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WO2025012241A1 - Composition pour augmenter une compétence cognitive - Google Patents

Composition pour augmenter une compétence cognitive Download PDF

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Publication number
WO2025012241A1
WO2025012241A1 PCT/EP2024/069268 EP2024069268W WO2025012241A1 WO 2025012241 A1 WO2025012241 A1 WO 2025012241A1 EP 2024069268 W EP2024069268 W EP 2024069268W WO 2025012241 A1 WO2025012241 A1 WO 2025012241A1
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WO
WIPO (PCT)
Prior art keywords
composition
composition according
chewing gum
lecithin
powder
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
Application number
PCT/EP2024/069268
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German (de)
English (en)
Inventor
Faraz NOURANI
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Sfn Holding Ag
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Sfn Holding Ag
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Filing date
Publication date
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Priority to EP24740881.8A priority Critical patent/EP4598368A1/fr
Publication of WO2025012241A1 publication Critical patent/WO2025012241A1/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G4/00—Chewing gum
    • A23G4/06—Chewing gum characterised by the composition containing organic or inorganic compounds
    • A23G4/12—Chewing gum characterised by the composition containing organic or inorganic compounds containing microorganisms or enzymes; containing paramedical or dietetical agents, e.g. vitamins
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G4/00—Chewing gum
    • A23G4/06—Chewing gum characterised by the composition containing organic or inorganic compounds
    • A23G4/068—Chewing gum characterised by the composition containing organic or inorganic compounds containing plants or parts thereof, e.g. fruits, seeds, extracts
    • 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
    • A23L33/105—Plant extracts, their artificial duplicates or their derivatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/16—Ginkgophyta, e.g. Ginkgoaceae (Ginkgo family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
    • A61K36/258—Panax (ginseng)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/41—Crassulaceae (Stonecrop family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/68—Plantaginaceae (Plantain Family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/87—Vitaceae or Ampelidaceae (Vine or Grape family), e.g. wine grapes, muscadine or peppervine
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

Definitions

  • the present invention relates to a chewable composition, preferably a chewing gum-based composition, wherein the composition contains: a) lecithin; b) oligomeric procyanidins; c) at least one substance from the group consisting of glucosides, ginsenosides and bacosides; and d) preferably a chewing mass.
  • a chewable composition preferably a chewing gum-based composition, wherein the composition contains: a) lecithin; b) oligomeric procyanidins; c) at least one substance from the group consisting of glucosides, ginsenosides and bacosides; and d) preferably a chewing mass.
  • the invention relates, inter alia, to the following embodiments: 1.
  • Chewable composition preferably chewing gum-based composition, wherein the composition contains: a) lecithin; b) oligomeric procyanidins; c) at least one substance from the group consisting of glucosides, ginsenosides, and bacosides; and d) preferably a chewing base.
  • Composition according to embodiment 1 or 2 wherein the composition contains 500 mg - 1500 mg lecithin.
  • Composition according to one of embodiments 1 to 4 wherein the glycosides originate from Rhodiola rosea.
  • Composition according to one of embodiments 2 to 4 wherein the flavonoids originate from Ginkgo biloba.
  • Composition according to any one of embodiments 1 to 5 wherein the ginsenosides are derived from Panax ginseng.
  • the composition contains: a) 30 to 100 mg Rhodiola rosea powder; b) optionally 40 to 160 mg Ginkgo biloba powder; c) 50 to 200 mg Panax ginseng powder; d) 100 to 300 mg grape seed flour; and/or e) 50 to 200 mg Bacopa monnieri powder.
  • the composition additionally comprises poly-unsaturated fatty acids (PUFA).
  • PUFA poly-unsaturated fatty acids
  • compositions according to any one of embodiments 1 to 17 for increasing at least one cognitive ability, preferably for increasing concentration. 19.
  • the cognitive ability is selected from the group consisting of: memory, reaction speed, simultaneous perception and stress processing.
  • 20. Use according to embodiment 18 or 19, wherein the composition is chewed for at least a period of time that leads to an increase in cerebral blood flow through the angular vein.
  • 21. Use according to embodiment 20, wherein the composition is chewed for at least 3 minutes.
  • 22. Use according to any one of embodiments 18 to 21, wherein the use comprises repeated application within 28 days.
  • the composition is applied at least 3 times daily. 25.
  • a packaging system for a chewing gum-based composition comprising: a) a package capable of containing one or more chewing gum-based compositions; b) at least one chewing gum-based composition according to any one of embodiments 1 to 17; and c) optionally instructions for use of the chewing gum-based composition according to any one of embodiments 18 to 24.
  • the present invention relates to a composition comprising a) lecithin; b) oligomeric procyanidins; and c) at least one substance from the group consisting of glucosides, ginsenosides and bacosides, or at least one substance from the group consisting of glycosides, ginsenosides and bacosides.
  • the composition contains a) lecithin; b) oligomeric procyanidins; and c) at least two substances from the group consisting of glucosides, ginsenosides and bacosides.
  • the composition contains a) lecithin; b) oligomeric procyanidins; and c) at least one glucoside each, and d) at least one ginsenoside each.
  • the ingredients of the composition provide for an increase in cognitive ability (also called "neuroenhancement") in an individual to whom the composition is administered.
  • the composition can be referred to as or used for "a composition for increasing cognitive ability (also called “neuroenhancement”) in an individual".
  • the formulation of the composition is not limited and in principle any formulation is suitable that leads to an increase in cognitive ability in an individual to whom the composition is administered.
  • the composition is preferably a composition that can be administered orally or nasally.
  • the composition is preferably provided as a dosage unit.
  • the composition can be formulated as a liquid, capsule, tablet (in particular lozenge or chewable tablet), snus, powder, jelly, dragée, wine gum or gummy bears, granules, compressed or pastille, chewing gum, chewing bag and candy (in particular lozenges or chewing candy).
  • composition that can be administered orally is preferably not swallowed or swallowed later, but should remain in the oral cavity where the contents and active ingredients of the composition according to the invention are released and can then pass through the oral mucosa into the bloodstream and then into the brain. This results in rapid absorption of the contents and active ingredients of the composition according to the invention, which pass directly into the blood and then into the brain without passing through the intestinal wall and liver.
  • the composition can be placed, for example, under the tongue (sublingual) or in the cheek or lip pocket (buccal, between the cheek and gums) or - as will be explained further below - chewed.
  • a strip can be placed under the upper lip can be placed to the side.
  • the composition For oral administration, it is possible for the composition to dissolve in the mouth and thus release the ingredients and active ingredients (e.g. candy or snus) or for the composition to release the ingredients and active ingredients from itself in dissolved form in the mouth and then the reservoir is spat out again (e.g. chewing gum or chewing bag), whereby the chewing gum can alternatively be swallowed.
  • a formulation of the ingredients and active ingredients of the composition according to the invention as a spray or drops is particularly suitable.
  • the composition is sprayed or dripped into the nose and the ingredients and active ingredients are then absorbed through the nasal mucous membranes, which then reach the blood and then the brain directly without passing through the intestinal wall and liver.
  • the ingredients and active substances can be contained in a releasable form in the composition (i.e., homogeneously distributed) and/or the ingredients and active substances can form a filling or reservoir in the composition so that they can be released after ingestion by the individual.
  • Lecithins or, more precisely, chemically modified triglycerides
  • Lecithin causes a conversion of choline in the brain and nerves to acetylcholine, the most important neurotransmitter in the transmission of stimuli.
  • Lecithin is now an important component in many foods and is also used in medicine to treat ulcerative colitis. Many studies have shown the possible positive influence on brain performance and the safe classification of this phosphatidylcholine.
  • Oligomeric proanthocyanidins also called oligomeric procyanidins and abbreviated as OPC or PCO (oligomeric proanthocyanidins)
  • OPC are substances that occur naturally in plants and belong to the group of flavonoids and are classified as polyphenols.
  • OPC are mostly dimers or trimers of oligomeric catechins and have an antioxidant protective effect against the effects of free radicals.
  • OPC are found in most plants and have therefore always been part of the human diet. OPC are found mainly in grape seeds (grape seed flour), the skin and leaves of red grapes, the red skins of peanuts, coconuts, apples and the bark of the maritime pine (Pinus Maritima). The skins and seeds as well as the cores in particular contain high amounts of OPC.
  • Oligomeric proanthocyanidins are also found in high concentrations in red wine, and significantly less in white wine.
  • the main effect of OPC or its metabolites is their antioxidant effect.
  • the strongest OPC antioxidant described to date is 18.4 times as strong as vitamin C and 50 times as strong as vitamin E.
  • OPC may be catalysts that can enhance the positive effects of vitamins A, C and E. They also pass through the blood-brain barrier and can therefore possibly protect brain tissue from oxidative stress.
  • Glucosides are a group of organic substances in which an alcohol or phenol (R-OH) is bound to glucose via a glycosidic bond. They are therefore a subgroup of glycosides. Glucosides split off glucose during hydrolysis. Examples of glucosides include amygdalin and sucrose.
  • Ginsenosides are the active ingredients of ginseng and belong to the group of substances known as saponins. Saponins are secondary plant substances whose name is derived from the Latin word "sapo" (soap). Ginsenosides are mainly found in the small secondary roots and hair roots. Ginsenosides are said to have a variety of effects. For example, ginsenosides encourage brain cells to absorb more sugar and can thus help people to concentrate better and think more complexly. Bacosides are a group of different chemical substances that belong to the saponins or triterpene saponins.
  • Bacoside A consists of the individual components bacoside A3, bacoside II, bacopasaponin C and an isomeric compound of bacopasaponin C.
  • Bacoside A has antioxidant and anti-anxiety properties and improves memory performance.
  • Bacosides are mainly contained in Brahmi (Bacopa monnieri), which is used in Ayurvedic medicine.
  • the at least one substance from the group consisting of glucosides, ginsenosides and bacosides is preferably at least two substances or all three substances.
  • the at least one substance from the group consisting of glucosides, ginsenosides and bacosides is preferably glucosides and ginsenosides.
  • the composition according to the invention comprises glycosides, which preferably originate from Rhodiola rosea; and/or ginsenosides, which preferably from Panax ginseng; and/or bacosides, which preferably originate from Bacopa monnieri; and/or oligomeric procyanidins, which preferably originate from grape seed flour.
  • the composition according to the invention comprises glycosides, which preferably originate from Rhodiola rosea; and ginsenosides, preferably which originate from Panax ginseng; and oligomeric procyanidins, preferably which originate from grape seed flour.
  • the composition according to the invention comprises glycosides, which preferably originate from Rhodiola rosea; and ginsenosides, preferably which originate from Panax ginseng; and oligomeric procyanidins, preferably which originate from grape seed flour, and lecithin.
  • the composition according to the invention comprises Rhodiola rosea powder; Panax ginseng; and grape seed flour.
  • the composition according to the invention comprises Rhodiola rosea powder; Panax ginseng; lecithin; and grape seed flour.
  • the data in the embodiments below demonstrate that a composition with the active ingredients of the composition of the first aspect (which, according to the embodiments, has the form of a chewing gum-based composition) can significantly increase cognitive abilities.
  • the composition of the ingredients and active ingredients of the composition is surprisingly chosen in such a way that a considerable increase in cognitive abilities was achieved, which far exceeds the known effect of the individual ingredients and active ingredients and which was not to be expected.
  • the composition is a chewable composition, preferably a chewing gum-based composition, wherein the chewing gum-based composition additionally contains a chewing mass.
  • the present invention also relates in particular to a chewable composition, preferably a chewing gum-based composition, wherein the composition contains: a) lecithin; b) oligomeric procyanidins; c) at least one substance from the group consisting of glucosides, ginsenosides and bacosides; and d) preferably a chewing mass.
  • a chewable composition refers to any composition that can be chewed. Preferred examples are a chewable tablet, chewing dragée, chewing strip, wine gum or Gummy bears, chewing gum and chewing candy.
  • the chewable composition preferably chewing gum-based composition
  • the chewable composition is used according to the invention as an oral delivery system to administer the ingredients contained therein: a) lecithin; b) oligomeric procyanidins; and c) at least one substance from the group consisting of glucosides, ginsenosides and bacosides.
  • the aforementioned ingredients are preferably in a chewing mass.
  • the chewable composition preferably chewing gum-based composition, allows the release of the ingredient from the chewing mass over time while the chewable composition, preferably chewing gum-based composition, is chewed or masticated.
  • compositions preferably chewing gum-based compositions
  • a well-known example is nicotine chewing gum.
  • chewing gums are known from the state of the art that are suitable for removing the ingredients a) lecithin; b) oligomeric procyanidins; and c) at least one substance from the group consisting of glucosides, ginsenosides and bacosides and releasing them after oral administration.
  • Natural or synthetic chewing gums generally consist of a number of different components.
  • Elastomers provide elasticity and can consist of natural latex or synthetic rubber.
  • Various plasticizers, fillers and texturizers, oils and emulsifiers as well as antioxidants are added to a synthetic polymer matrix.
  • Rubber provides elasticity and can consist of natural latex or synthetic rubber.
  • Resins can ensure strong binding, e.g. glycerol esters of rubber, terpene resins or polyvinyl acetate.
  • Waxes serve as plasticizers and are paraffin or microcrystalline wax.
  • Fats act as plasticizers and come mainly from hydrogenated vegetable oils.
  • Emulsifiers contribute to hydration; the most common are lecithin or glycerin monostearate.
  • Natural milky juices that are approved for the production of gum base include those of the sapotes, dogbane, mulberry and spurge plants.
  • the sapotes include the muscari tree, from which chicle is obtained, and the balata tree. From its milky juice, called Gum base is also made from balata.
  • the milky juices of dogbane plants such as the jelutong of Dyera costulata or the leche caspi of Couma macrocarpa are also used.
  • the milky juices of the mulberry family and the spurge family also serve as starting material for chewing base.
  • the chewing gum-based composition is preferably a chewing gum.
  • the chewing gum-based composition is preferably a chewable dosage unit.
  • the chewable dosage unit is preferably a chewing gum.
  • the ingredients can be contained in the chewing mass itself in a releasable form and/or the chewing gum-based composition is filled with the ingredients so that they can be released by chewing. Fillings are particularly suitable for (other) ingredients that cannot or can only be introduced with difficulty into the chewing mass itself.
  • the ingredients and active substances of the composition according to the invention surprisingly bring about a considerable increase in cognitive abilities. This considerable increase can be achieved according to the invention in particular by formulating it as a chewable composition, preferably a chewing gum-based composition. This formulation guarantees rapid effectiveness and avoids a first-pass effect (ie the conversion of a drug during its first passage through the liver).
  • this formulation guarantees that the ingredients and active substances of the composition according to the invention reach the brain quickly and effectively, so that the considerable increase in cognitive abilities can be achieved quickly and highly efficiently.
  • the angular vein is stimulated to pump blood to the brain (see Imfeld (1999), Crit Rev Oral Biol Med, 10(3):405-419; Rajesh et al. (2012), Journal of Drug Delivery & Therapeutics, 2(6):90-95; Jayaprakash et al. (2015), Biomedical and Pharmacology Journal, 8(October Spl Edition):91-97; and Iwanaga et al. (2022), PLoS One, 17(10): e027612).
  • the composition also contains a substance from the group of flavonoids.
  • Flavonoids are found in many plant-based foods such as lemons, nopal (opuntia prickly pear cactus), grapes, tea and chocolate containing cocoa (there: epicatechin). Some flavonoids have a vasoconstrictor effect, others act against inflammation and histamine or have antiviral and antispasmodic effects. Some flavonoids, such as quercetin, are good antioxidants. Numerous studies confirm a correlation between the intake of flavonoids and the reduction in the risk of various diseases, such as cancer or cardiovascular disease. According to a preferred embodiment, the composition contains 500 mg - 1500 mg of lecithin.
  • the 500 mg - 1500 mg of lecithin are always more preferably 600 mg - 1400 mg, 700 mg - 1300 mg, 800 mg - 1200 mg or 900 mg - 1100 mg and about 1000 mg.
  • the 500 mg - 1500 mg of lecithin are always more preferably 500 mg to 1000 mg.
  • the 500 mg - 1500 mg lecithin is preferably 500 mg or 1000 mg.
  • the 500 mg - 1500 mg lecithin is preferably based on a dosage unit.
  • the composition contains 10%-30% lecithin, preferably 15%-25% lecithin, more preferably about 20% lecithin.
  • the lecithin is preferably sunflower lecithin.
  • the chewing gum-based composition according to Example 2 below contains 1000 mg sunflower lecithin.
  • the composition contains the glycosides derived from Rhodiola rosea.
  • the composition contains the glycosides derived from Rhodiola rosea.
  • the root drug Rhodiola rosea (roseroot) is used primarily to combat "mental fatigue” and is also a means of improving brain performance. In particular, it facilitates the transport of signaling substances in the brain.
  • the possible inhibition of monoamine oxidase leads to an increased permeability of the blood-brain barrier for various neurotransmitters such as serotonin and dopamine. To date, there are no entries on known interactions and serious side effects.
  • the composition contains 30 mg to 100 mg, more preferably 30 mg to 80 mg, even more preferably 30 mg to 70 mg of Rhodiola rosea powder; preferably per dosage unit.
  • the composition contains 1% to 2% Rhodiola rosea powder.
  • the 1% to 2% Rhodiola rosea powder preferably refers to one dosage unit.
  • the composition contains the flavonoids that come from Ginkgo biloba.
  • the Ginkgo biloba plant, which is originally native to China, has been used as a phytopharmaceutical for centuries. The effects and ingredients of this highly potent plant have been researched very carefully today.
  • Ginkgo biloba Due to the broad spectrum of effects of the ingredients of Ginkgo biloba, which mainly contains flavonoglycosides and terpene lactones, and thus leads to the reduction of oxidative stress and the elimination of free radicals, it is used as the most common nootropic.
  • the cellular protective effect due to the supporting function of the mitochondria, which are required to produce adenosine triphosphate (ATP), is clearly the focus here.
  • Ginkgo biloba is the most researched nootropic and is considered to be very safe.
  • the composition contains ginsenosides that come from Panax ginseng.
  • Panax ginseng ginseng root
  • the ginseng root is also classified as safe.
  • the composition contains 50 mg to 200 mg, more preferably 50 mg to 100 mg of Panax ginseng; preferably based on a dosage unit.
  • the composition contains 1% to 3% Panax ginseng.
  • the 1% to 3% Panax ginseng preferably relates to a dosage unit.
  • the composition contains the bacosides which come from Bacopa monnieri.
  • the tropical plant Bacopa monnieri (Brahmi leaves) has been used as a concentration agent in Indian naturopathy for over 3000 years. Due to its potent cerebral effects, this plant is becoming increasingly attractive on the pharmaceutical market. The mode of action has been researched in numerous studies, but many more clinical studies are still needed to make therapeutic and medical statements. In summary, the leaves of the Brahmi plant have enormous potential and numerous applications are being developed.
  • the composition contains the oligomeric procyanidins that come from grape seed flour.
  • the composition contains 100 to 300 mg, more preferably 100 mg to 250 mg of grape seed flour; preferably based on a dosage unit.
  • the composition contains 1% to 10%, preferably 4% to 6%, more preferably 5% of grape seed flour.
  • the % grape seed flour preferably refers to a dosage unit. Grape seed flour obtained from grapes is often used as an antioxidant due to the high proportion of oligomeric proanthocyanidins (OPC). They also act as radical scavengers to prevent the formation of free radicals and subsequently oxidative stress.
  • OPC oligomeric proanthocyanidins
  • the composition contains: a) 30 to 100 mg Rhodiola rosea powder; b) optionally 40 to 160 mg Ginkgo biloba powder; c) 50 to 200 mg Panax ginseng powder; d) 100 to 300 mg grape seed flour; and/or e) 50 to 200 mg Bacopa monnieri powder.
  • the 30 to 100 mg Rhodiola rosea powder is more preferably 40 to 90 mg, 50 to 80 mg, 60 to 70 mg and about 66.6 mg.
  • the 40 to 160 mg Ginkgo biloba powder is more preferably 50 to 150 mg, 60 to 140 mg, 70 to 150 mg and about 80 mg.
  • the term "optional" in the context of the Ginkgo biloba powder specifies that the Ginkgo biloba powder is an optional ingredient; see also table in Examples 2 and 6.
  • the 50 to 200 mg of Panax ginseng powder are more preferably 60 to 190 mg, 70 to 150 mg, 80 to 130 mg, 90 to 110 mg and about 100 mg.
  • the 100 to 300 mg of grape seed flour are more preferably 150 to 290 mg, 230 to 290 mg, 250 to 270 mg and about 233.3 mg.
  • the 50 to 200 mg of Bacopa monnieri powder are more preferably 60 to 190 mg, 70 to 150 mg, 80 to 130 mg, 90 to 110 mg and about 100 mg.
  • the composition contains per dosage unit: Ingredients [mg] [%] Rhodiola rosea (rose root) 30-100 1-2 Panax ginseng 50-200 preferably 1-3, preferably 2- 50-100 2.5 Grape seed flour 100-300 1-10, preferably 5 Sunflower lecithin 500-1500 preferably 500- 10-30, preferably 20 1000 Atherolum menthae piperita 0-40 1-2 (peppermint oil) Xylitol 0-600, preferably 0- 3 00 0-15 Vitamin B6 0-0.5 0-0.01 Vitamin B12 0-0.0013 0- ⁇ 0.01 Gum base 0-3000, preferably 0-80, preferably 30- 500-3000 80, preferably 50-70
  • the chewing gum-based composition according to Examples 2 and 6 below contains the most preferred of the above amounts.
  • the above-mentioned plant powders as well as grape seed flour are commercially available, e.g. as dietary supplements.
  • the manufacturers from which the plant powders and grape seed flour were used for Examples 2 and 6 can be found in the table in Examples 2 and 6.
  • powders can also be made independently from plant material.
  • plant parts leaf, stems, flowers, roots, etc.
  • whole plants are dried, e.g. in the air, in a drying cabinet or with a supply of warm air.
  • the dried plant parts or plants can then be crushed into a powder, e.g. in a mill or mortar.
  • the dried plant material and/or powder can be extracted with a solvent, such as water, ethanol, or chloroform, and then dried again to form a powder.
  • ginseng powder can be made as follows. (1) Drying the ginseng root, (2) Crushing the dried ginseng root, (2) Extraction of the active ingredients with ethanol concentration by evaporation of the extraction agent, (3) Disinfection if necessary, (4) Homogenization with auxiliary materials if necessary, (5) Drying process, (6) Grinding the resulting powder (if necessary first coarsely, then finely).
  • Grape seed flour also grape seed powder
  • grape seed powder is a dark brown flour that is obtained from the seeds (kernels) of grapes. To produce grape seed flour, the grape seeds are extracted from the press residue, the pomace, after the pressing process for wine production.
  • a "de-stemming machine” (rotating sieve) separates the seeds from the berry skin.
  • the loose seeds are then dried using warm air and cleaned with an air sifter or a grain winch so that the pure seeds remain.
  • the seeds are then dried again.
  • the dried seeds are then cold pressed to extract grape seed oil from them.
  • the press cake remains, which is crushed using a conveyor screw, processed into granules by a roller mill and finally ground very finely into grape seed flour in a grain mill or whirlpool mill.
  • the heat generated is 40 to 50 °C, although this temperature is only reached for a few seconds. This gentle production process makes it possible to preserve the nutritionally valuable ingredients of the grape seed flour.
  • the composition also contains polyunsaturated fatty acids (PUFA).
  • PUFA polyunsaturated fatty acids
  • unsaturated fatty acids have at least one double bond in the carbon chain. Those with only one double bond are referred to as monounsaturated. If the fatty acid has two or more double bonds, it is called polyunsaturated fatty acid.
  • the best known and preferred representatives of polyunsaturated fats are omega-3 fatty acids and/or omega-6 fatty acids. They differ in where in the chemical structure the last double bonds between carbon atoms occur.
  • the composition contains the PUFA that comes from camelina oil.
  • camelina oil has a particularly high proportion of monounsaturated omega-3 fatty acids (28-42%) and polyunsaturated omega-3 fatty acids such as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (60.5%). Due to these ingredients, camelina oil is ideal for supplying the brain with sufficient fatty acids that can achieve optimal brain performance. Furthermore, results have been obtained for positive cardiovascular protective effects. This oil is one of the healthiest oils. (10,11).
  • Camelina oil is preferably used in an amount of 50 to 500 mg, preferably 100 to 250 and most preferably around 166.6 mg.
  • the composition additionally comprises xylitol.
  • Xylitol ((2R,3r,4S)-pentane-1,2,3,4,5-pentol) is a sweetener also known as xylitol or pentanpentol. The substance occurs naturally in many fruits, berries and vegetables. Since xylitol was originally obtained from the bark of birch trees, it is also called birch sugar.
  • the composition comprises 1000 to 2000 mg of xylitol.
  • the 1000 to 2000 mg of xylitol are more and more preferably 1200 to 1900 mg, 1300 to 1800 mg, 1500 to 1700 mg and about 1600 mg.
  • the composition contains 100 to 2000 mg, preferably 100 to 1000 mg, more preferably 100 to 600 mg, more preferably 200 mg to 400 mg, even more preferably about 300 mg of xylitol; preferably based on a dosage unit.
  • the composition contains 1% to 20%, preferably 5% to 15% xylitol.
  • the % xylitol preferably relates to a dosage unit.
  • the composition additionally contains poly-unsaturated fatty acids (PUFA), preferably where the PUFA originate from camelina oil; and/or where the composition additionally comprises xylitol.
  • PUFA poly-unsaturated fatty acids
  • the chewing gum-based composition according to examples 2 and 6 below contains the most preferred of the above amounts.
  • stevia can also be used, e.g. in the form of stevia powder.
  • Stevia is or preferably comprises one or more rebaudiosides and most preferably rebaudioside-A.
  • the composition additionally comprises a flavoring agent, wherein the flavoring agent is preferably peppermint oil.
  • compositions such as chewing gum are available in a variety of flavors on the market, such as peppermint, various fruit flavors, cinnamon or cola.
  • Peppermint has the largest market share and is therefore also the preferred flavor of the composition according to the invention.
  • the composition comprises 50 to 120 mg of peppermint oil.
  • the 50 to 120 mg of peppermint oil are always more preferably 60 to 100 mg, 70 to 90 mg and about 80 mg.
  • the composition comprises 20 to 120 mg of peppermint oil.
  • the 50 to 120 mg of peppermint oil are even more preferably 30 to 100 mg, even more preferably 40 to 80 mg; preferably based on a dosage unit.
  • the composition contains 1% to 2% peppermint oil.
  • the % peppermint oil preferably relates to a dosage unit.
  • the composition additionally contains at least one vitamin, preferably from the group of B vitamins, more preferably vitamin B6 and/or vitamin B12, even more preferably vitamin B6 and B12.
  • the vitamins are dosed in accordance with the guidelines of the German Nutrition Society and are at or below the maximum doses specified therein.
  • 0.25 mg to 0.5 mg vitamin B6 and/or 0.65 ⁇ g to 1.3 ⁇ g vitamin B12 are contained in a dosage unit.
  • the dosage unit containing 0.25 mg vitamin B6 and/or 0.65 ⁇ g vitamin B12 is administered up to 6 times daily.
  • the dosage unit containing 0.5 mg vitamin B6 and/or 1.3 ⁇ g vitamin B12 is administered up to 3 times daily.
  • the chewing gum-based composition according to examples 2 and 6 below contains the most preferred of the above amounts.
  • the composition additionally comprises a substance which improves the passage through the blood-brain barrier for at least one of the ingredients. In order for the at least one ingredient to pass from the blood to the brain, it must pass across the blood-brain barrier.
  • the blood-brain barrier also known as the blood-brain barrier, or blood-brain barrier, is the selective physiological barrier between the fluid spaces of the bloodstream and the central nervous system.
  • the substance comprises nanoliposomes and lipopeptide micelles.
  • nanotechnological formulations such as nanoliposomes and lipopeptide micelles.
  • nanoliposomes and lipopeptide micelles have been shown to be suitable for transporting drugs and other substances across the blood-brain barrier.
  • the nanoliposomes and lipopeptide micelles act as carrier systems for the substances.
  • Nanoliposomes are submicron bilayer lipid vesicles for the encapsulation and release of at least one bioactive agent (Motafari, Methods Mol Biol. 2010;605:29-50).
  • Lipopeptide micelles are lipopeptides in the form of micelles and are also for the encapsulation and release of at least one bioactive agent.
  • the at least one bioactive agent is at least one substance from a) lecithin; b) oligomeric procyanidins; and c) at least one substance from the group consisting of glucosides, ginsenosides and bacosides.
  • the present invention relates to the use of the composition of the first aspect of the invention for increasing at least one cognitive ability, preferably for increasing concentration.
  • the composition is preferably administered orally to an individual, who is preferably a human, and chewed.
  • Cognition is mental perception. Human cognitive abilities describe their ability to perceive and process signals from the environment. The word 'cognitive' is derived from the Latin 'cognoscere', which can be translated as 'to recognize'. Cognition takes place always and everywhere. It is what makes the environment a part of human life and is, so to speak, the interface between the environment and the brain. In the current state of research, cognitive abilities are increasingly being separated from intellectual abilities.
  • cognitive abilities include the ability to learn and the ability to abstract.
  • Cognitive abilities include, among others and preferably, attention, memory, learning, creativity, planning, orientation, imagination and/or will.
  • the increase in at least one cognitive ability can be determined by numerous measurable parameters.
  • the embodiments demonstrate, based on all of these measurable parameters, an increase in at least one cognitive ability by the composition according to the invention. It should be understood that the above use is general and also preferably a non-medical use. The use is therefore preferably used in individuals (in particular people) who do not have pathologically impaired cognitive abilities.
  • the composition is used to increase at least one (normally pronounced) cognitive ability, preferably to increase concentration.
  • the cognitive ability is selected from the group consisting of: memory, reaction speed, simultaneous perception and stress processing. These cognitive abilities in particular play a role in school, studies, work and sport and are therefore cognitive abilities that can increase an individual's performance.
  • the composition is chewed for at least a period of time that leads to an increase in cerebral blood flow through the angular vein.
  • Cerebral blood flow (CBF) is a measure of the supply of blood to the brain over a certain period of time.
  • the angular vein is a blood vessel in the head. It is a branch of the facial vein (vena facialis).
  • the angular vein runs in the nasal corner of the eyelid, to the side of the artery of the same name, and can be seen through the skin of thin-skinned people.
  • the angular vein forms an anastomosis with the superior ophthalmic vein, which drains into the cavernous sinus, among other things.
  • the angular vein thus forms a direct connection between the facial veins and the brain.
  • Scientific studies using memory and concentration tests show that chewing gum promotes blood flow to the brain and thus brain performance.
  • the composition is chewed for at least 3 minutes.
  • the at least 3 minutes are preferably at least 5 minutes, more preferably at least 7 minutes and most preferably about 10 minutes.
  • the use comprises the repeated application of the composition of the first aspect of the invention within 28 days.
  • the 28 days correspond to the application period of the embodiments.
  • an application of the composition of the first aspect of the invention which comprises 7 days, 14 days or 21 days.
  • the composition is applied daily.
  • the composition is applied at least 3 times a day, preferably several times a day.
  • the composition is applied 3 to 6 times a day.
  • the present invention relates to a packaging system for a chewing gum-based composition, comprising: a) a packaging that is able to accommodate one or more compositions of the first aspect of the invention; b) at least one composition of the first aspect of the invention; and c) optionally instructions for the use of the composition of the first aspect of the invention.
  • compositions of the first aspect of the invention includes, for example, boxes made of plastic or paper, blister packs or outer packaging made of foil and/or paper.
  • the composition of the first aspect of the invention can be in the form of, for example, Chewing gum strips, chewing gum tabs or even chewing gum dragees.
  • the instructions for use of the composition of the first aspect preferably state the dosage (e.g. daily or 3x daily or 6x daily), the application period (e.g. 28 days) and/or the chewing time (e.g. 3 or 10 min).
  • dosage e.g. daily or 3x daily or 6x daily
  • the application period e.g. 28 days
  • the chewing time e.g. 3 or 10 min.
  • FIG 1 Basic perceptual accuracy T1-T2 in study 1
  • Figure 2 Simultaneous perceptual accuracy T1-T2 in study 1
  • Figure 3 Block span (working memory) T1-T2 in study 1
  • Figure 4 Percentile ranks for verbal memory T1-T2 in study 2
  • Figure 5 Percentile ranks for simultaneous capacity T1-T2 in study 2
  • Figure 6 Percentile ranks for multiple demands T1-T2 in study 2
  • Figure 7 Percentile ranks for short-term memory correct retrieval T1-T2 in study 2
  • Figure 8 Percentile ranks for simultaneous capacity perceptual accuracy T1-T2 in study 2
  • the examples explain the invention.
  • Example 2 Composition of study chewing gum (verum) Preparation Ingredients Dosage per Free on the market Manufacturer Category Presence of chewing gum available Substance/drug Rhodiola rosea Glycosides 66.6 mg Yes, health food stores, BULK POWDERS NEM * Powdered, (Roseroot) (salidroside, pharmacies 100% roseroot, rosavin, etc.) 3% salidroside content Ginkgo biloba ** Flavonoids, 80 mg Yes, health food stores, Terra Elements, NEM * Powdered ginkgolic acids, pharmacies Indigo-Herbs leaf powder, ginkgolides ⁇ 42°C dried and gently ground, 100% ginkgo biloba powder, organic quality Panax ginseng ginsenosides 100 mg Yes, health food stores, ALSIGINSENG NEM * Powdered, pharmacies 100% ginseng, organic quality Grape seed flour oligomers 233.3 mg Yes, Food - Food Powdered Procyanidins retail, e
  • Example 5 Discussion In studies 1 and 2 it was shown that the study chewing gum (verum) improved the cognitive abilities of the test subjects after consumption over 28 days, in particular the following improvements in cognitive abilities were achieved:
  • Example 6 Further compositions and dosages of the chewing gum Ingredients Dosage per chewing gum Example 6.1 Example 6.1 Example 6.2 Example 6.2 [%] [%] Rhodiola rosea (rose root) 33.3 mg 1.4 66.6 mg 1.5 Panax ginseng 50 mg 2.0 100 mg 2.2 Grape seed flour 116.6 mg 4.8 233.3 mg 5.1 Sunflower lecithin 500 mg 20.5 1000 mg 21.8 Atherolum menthae piperita 40 mg (1 1.6 80 mg (1-2 1.7 (Peppermint Oil) (optional drop) drop) inhalant) Xylitol (optional ingredient) 300 mg 12.3 300 mg 6.5 Vitamin B6 0.25 mg 0.01 0.5 mg 0.01 Vitamin B12 0.65 ⁇ g ⁇ 0.01 1.3 ⁇ g ⁇ 0.01 Gum mass approx 1400 mg approx 57.

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Abstract

La présente invention concerne une composition à mâcher, de préférence une composition à base de gomme à mâcher, la composition contenant : de la lécithine; b) des procyanidines oligomères; c) au moins une substance du groupe constitué par les glucosides, les ginsénosides et les bacosides; et d) de préférence une substance masticatoire.
PCT/EP2024/069268 2023-07-07 2024-07-08 Composition pour augmenter une compétence cognitive Pending WO2025012241A1 (fr)

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