US20130096075A1 - Composition for prevention, amelioration or treatment of metabolic syndrome - Google Patents

Composition for prevention, amelioration or treatment of metabolic syndrome Download PDF

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US20130096075A1
US20130096075A1 US13/261,527 US201113261527A US2013096075A1 US 20130096075 A1 US20130096075 A1 US 20130096075A1 US 201113261527 A US201113261527 A US 201113261527A US 2013096075 A1 US2013096075 A1 US 2013096075A1
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Prior art keywords
composition
caffeine
hesperidin
mass
feed
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US13/261,527
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Inventor
Tatsuya Ohara
Koutarou Muroyama
Shinji Murosaki
Yoshihiro Yamamoto
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House Wellness Foods Corp
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House Wellness Foods Corp
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Assigned to HOUSE WELLNESS FOODS CORPORATION reassignment HOUSE WELLNESS FOODS CORPORATION ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: MUROSAKI, SHINJI, MUROYAMA, KOUTAROU, OHARA, TATSUYA, YAMAMOTO, YOSHIHIRO
Publication of US20130096075A1 publication Critical patent/US20130096075A1/en
Priority to US14/733,592 priority Critical patent/US9993493B2/en
Priority to US15/975,729 priority patent/US20180264020A1/en
Abandoned legal-status Critical Current

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    • 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
    • A61K31/33—Heterocyclic compounds
    • 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
    • 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
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
    • 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
    • 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
    • A23L33/30—Dietetic or nutritional methods, e.g. for losing weight
    • 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
    • A61K31/33—Heterocyclic compounds
    • 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 
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52—Purines, e.g. adenine
    • A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
    • 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
    • A61K31/74—Synthetic polymeric materials
    • A61K31/765—Polymers containing oxygen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Definitions

  • the present invention relates to a composition for the prevention, amelioration, or treatment of metabolic syndrome. More specifically, the present invention relates to a composition comprising a polyphenol and a xanthine derivative, for the prevention, amelioration, or treatment of metabolic syndrome.
  • Metabolic syndrome is a condition with, in addition to visceral fat accumulation, a combination of risk factors for arteriosclerosis, such as disorders of carbohydrate metabolism (abnormal glucose tolerance, diabetes), disorders of lipid metabolism (hypertriglyceridemia, hypercholesterolemia, and low levels of HDL cholesterol), and hypertension.
  • Non Patent Literature 1 Low-molecular proanthocyanidins are known to have an effect of preventing or improving dysregulated production of adipocytokine and a thermogenic effect by inducing gene expression of uncoupling protein 1 (UCP1) (Non Patent Literature 2). Furthermore, they are known to have an effect of reducing body weight, abdominal circumference, visceral fat, and the like (Non Patent Literature 3).
  • Caffeine is known to have an antagonist effect on adenosine receptors (Non Patent Literature 4), an effect of increasing circulating catecholamine level, and an effect of inhibiting phosphodiesterase activity, which activities facilitate lipid metabolism (Non Patent Literature 5), to inhibit hepatic lipogenesis, and to increase resting metabolic rate and energy consumption, resulting in decrease in body fat and body weight (Non Patent Literature 6).
  • Non Patent Literature 4 an antagonist effect on adenosine receptors
  • Non Patent Literature 5 an effect of increasing circulating catecholamine level
  • an effect of inhibiting phosphodiesterase activity which activities facilitate lipid metabolism
  • Non Patent Literature 6 to inhibit hepatic lipogenesis
  • each component by itself acts on lipid metabolism.
  • dietary therapy based on restricted calorie intake, exercise therapy, and medicinal therapy by use of an anorexiant, etc. are carried out.
  • dietary therapy which often involves excessively restricted diet, requires complicated calorie calculation and strong will, and therefore is difficult for an individual to manage for a long period of time.
  • exercise therapy which is associated with mental and physical pain, is very difficult to continue for a long period of time in this busy modern society. It is effective to try to consume as much body fat as possible as energy source during exercise, but people with a tendency to become obese have slow fat metabolism, and it is difficult for them to decrease body fat by exercise.
  • composition that can contribute to the prevention or amelioration of obesity by inhibiting hepatic lipogenesis, facilitating resolution of fat accumulated in fat cells, and effectively burning fat, and so has development of a food or drink or a medicine comprising the composition.
  • the present invention was made in the light of the above-mentioned problems, and an objective of the invention is to provide a composition for the prevention, amelioration, or treatment of metabolic syndrome, disorders of lipid metabolism (for example, fatty liver, hyperlipidemia), obesity (for example, visceral fat accumulation, subcutaneous fat accumulation), or the like, and a food or drink or a medicine comprising the composition.
  • disorders of lipid metabolism for example, fatty liver, hyperlipidemia
  • obesity for example, visceral fat accumulation, subcutaneous fat accumulation
  • a medicine comprising the composition.
  • compositions which effectively decrease body fat After intensive investigations into compositions which effectively decrease body fat, the present inventors found that a composition comprising hesperidin or a derivative thereof and caffeine, or a composition comprising a low-molecular proanthocyanidin and caffeine has an anti-obesity effect which is surprisingly stronger than the effect exhibited when each of the components is used alone. The inventors have carried out further investigations and completed the present invention.
  • the present invention relates to the following.
  • composition of the present invention has an effect of inhibiting body weight increase, visceral fat accumulation, subcutaneous fat accumulation, and increase in plasma triglyceride level, and therefore is useful as a medicine, a food or drink, or a feed for weight loss; prevention or amelioration of obesity; and also prevention, amelioration, or treatment of metabolic syndrome, such as diabetes, hypertriglyceridemia, hypercholesterolemia, and arteriosclerosis, which are considered to result from visceral fat accumulation.
  • FIG. 1 is a graph showing the changes in body weight before and after the test period in Test Example 1.
  • FIG. 2 is a graph showing the feed intake during the first 10 days of the test period in Test Example 1.
  • FIG. 3 is a graph showing the weight of mesenteric fat tissue per 100 g of body weight in Test Example 1.
  • FIG. 4 is a graph showing the changes in body weight before and after the test period in Test Example 2.
  • FIG. 5 is a graph showing the feed intake during the first 10 days of the test period in Test Example 2.
  • FIG. 6 is a graph showing the weight of subcutaneous fat tissue per 100 g of body weight in Test Example 2.
  • FIG. 7 is a graph showing the weight of mesenteric fat tissue per 100 g of body weight in Test Example 2.
  • FIG. 8 is a graph showing the changes in body weight before and after the test period in Test Example 3.
  • FIG. 9 is a graph showing the feed intake during the first 10 days of the test period in Test Example 3.
  • FIG. 10 is a graph showing the total weight of subcutaneous, epididymal, and mesenteric fat tissues per 100 g of body weight in Test Example 3.
  • FIG. 11 is a graph showing the changes in plasma triglyceride level before and after the test period.
  • the present invention provides a composition for the prevention, amelioration, or treatment of metabolic syndrome, the composition comprising (a) and (b), wherein
  • Hesperidin is a kind of polyphenol found abundantly in the skin of citrus fruits, such as mandarin oranges, and is also called vitamin P. Hesperidin is a hesperetin glycoside, and hesperetin is an aglycon of hesperidin. Examples of hesperidin derivatives include those prepared by addition of a methyl group, an ethyl group, a saccharide, or the like to hesperidin.
  • hesperidin derivatives having a saccharide include, for example, a glucosyl hesperidin prepared by adding, to hesperidin, one or more kinds of saccharides, such as glucose, fructose, galactose, and xylose, in an equimolar or excess amount with use of a glycosyltransferase.
  • Glucosyl hesperidins can be preferably used in the composition of the present invention because they are excellent in water solubility, processability into food or the like, bioabsorbability, etc.
  • alpha-glycosyl hesperidin in which D-glucose residues in an equimolar or excess amount are bound to hesperidin by alpha bonds, is preferred.
  • Proanthocyanidin means a group of polyphenol compounds that produce anthocyanidin when treated with an acid, and is a generic term that includes flavan-3-ols (also referred to as catechins); and polymeric procyanidins, prodelphinidins, propelargonidins, and the like which are dimers, trimers, tetramers, and decamers or higher order polymers of flavan-3-ol esterified with gallic acid; and stereoisomers thereof.
  • Proanthocyanidin is known to exist in various plants.
  • plants containing proanthocyanidin include fruit vegetables, such as astringent persimmons, bananas, apples, pears, grapes, strawberries, avocados, cowberries, hawthorn apples, lotus roots, buckwheat, litchee nuts, and Myrica rubra; herbs and spices; wood; cinnamon; and pine bark.
  • fruit vegetables such as astringent persimmons, bananas, apples, pears, grapes, strawberries, avocados, cowberries, hawthorn apples, lotus roots, buckwheat, litchee nuts, and Myrica rubra
  • herbs and spices wood; cinnamon; and pine bark.
  • the polyphenol containing 15 mass % or more of proanthocyanidin having a polymerization degree of 1 to 3, which is used as the component (a), needs to contain 15 mass % or more of proanthocyanidin having a polymerization degree of 1 to 3, and preferably 20 mass % or more, more preferably 25 mass % or more, further more preferably 30 mass % or more, and particularly preferably 35 mass % or more of such a proanthocyanidin.
  • the content of proanthocyanidin having a polymerization degree of 1 to 3 in the polyphenol can be determined by a publicly known measuring method, such as HPLC.
  • a method for increasing the content of proanthocyanidin having a polymerization degree of 1 to 3 in the polyphenol for example, a method of discarding polyphenol portions other than proanthocyanidin having a polymerization degree of 1 to 3, or a method of decomposing proanthocyanidin having a polymerization degree of 4 or more into low molecules (see, for example, WO 2006/090830) can preferably be used.
  • a composition containing a polyphenol containing 15% or more of proanthocyanidin having a polymerization degree of 1 to 3 is commercially available (for example, Oligonol (trade name), AMINO UP CHEMICAL Co. , Ltd.), and such a product can also be preferably used as the component (a) of the present invention.
  • the component (a) may be any one kind, or a combination of two or more kinds selected from a polyphenol containing 15 mass % or more of proanthocyanidin having a polymerization degree of 1 to 3, hesperidin, a hesperidin derivative, and hesperetin.
  • xanthine derivatives examples include xanthin, aminophylline, theophylline, cholinetheophylline, caffeine, theobromine, 1,7-dimethylxanthin, oxtriphylline, diprophylline, and proxyphylline. Inter alia, caffeine, theophylline, and theobromine are preferred.
  • the component (b) may be any one kind, or a combination of two or more kinds in combination of the xanthine derivatives exemplified above.
  • the blending ratio (mass ratio) of the component (a) and component (b) in the composition of the present invention is not particularly limited as long as the desired effects of the present invention can be achieved, but the mass ratio of (a):(b) is preferably about 1:(0.001 to 5), more preferably about 1:(0.01 to 0.5), and still more preferably about 1:(0.02 to 0.3).
  • the composition of the present invention has been confirmed to have an effect of inhibiting body weight increase, visceral fat accumulation, subcutaneous fat accumulation, and increase in plasma triglyceride level (see Test Examples 1 to 3), and therefore can be preferably used for the prevention, amelioration, or treatment of metabolic syndrome.
  • the components (a) and (b) in the composition of the present invention which are each already known to be useful when used alone for improving lipid metabolism or the like, are very useful when used in combination with each other, in that they exhibit a much stronger effect than in the cases where they are used alone, and that they produce a prominent effect even at low doses at which they separately cannot work (see Test Examples 1 to 3).
  • the composition of the present invention can be used as a medicine, a food or drink, a feed, a food additive, a feed additive, or the like.
  • the composition is particularly preferable for use in a medicine, a food or drink, or a feed.
  • a medicine comprising the composition of the present invention may be orally or parenterally administered to a mammal.
  • oral preparations include a granule, a powder, a tablet (including a sugar-coated tablet), a pill, a capsule, a syrup, an emulsion, and a suspension.
  • parenteral preparations include injections (for example, a subcutaneous injection, an intravenous injection, an intramuscular injection, and an intraperitoneal injection), an intravenous fluid, external preparations (for example, an intranasal preparation, a transdermal preparation, and an ointment), and suppositories (for example, an intrarectal suppository and an intravaginal suppository).
  • compositions can be formulated with use of a pharmaceutically acceptable carrier by a method conventionally used in the art.
  • the pharmaceutically acceptable carrier include an excipient, a binder, a diluent, an additive, a flavor, a buffer, a thickener, a colorant, a stabilizer, an emulsifier, a dispersant, a suspending agent, a preservative, and the like.
  • magnesium carbonate, magnesium stearate, talc, sugar, lactose, pectin, dextrin, starch, gelatin, tragacanth, methylcellulose, sodium carboxymethylcellulose, low-melting-point wax, cacao butter, or the like can be used as the carrier.
  • Oral solid preparations (a tablet, a pill, a capsule, a powder, a granule, or the like) can be formulated by conventional means including mixing an active ingredient with an excipient (lactose, mannitol, glucose, microcrystalline cellulose, starch, or the like), a binder (hydroxypropylcellulose, polyvinyl pyrrolidone, magnesium aluminometasilicate, or the like), a disintegrant (calcium cellulose glycolate, or the like), a lubricant (magnesium stearate, or the like), a stabilizer, a solubilizer (glutamic acid, aspartic acid, or the like), or the like.
  • an excipient lactose, mannitol, glucose, microcrystalline cellulose, starch, or the like
  • a binder hydroxypropylcellulose, polyvinyl pyrrolidone, magnesium aluminometasilicate, or the like
  • Oral liquid preparations are formulated by dissolving, suspending, or emulsifying an active ingredient in a generally used diluent (purified water, ethanol, or the mixture thereof, or the like).
  • the liquid preparation may further comprise a wetting agent, a suspending agent, an emulsifier, a sweetener, a flavor, an essence, a preservative, a buffer, or the like.
  • Injections include a solution, a suspension, an emulsion, and a solid injection to be dissolved or suspended in a solvent before use. Injections are formulated by dissolving, suspending, or emulsifying an active ingredient in a solvent.
  • a solvent for example, distilled water for injection; physiological saline; a vegetable oil; alcohols, such as propylene glycol, polyethylene glycol, and ethanol; and a combination thereof may be used.
  • the injection may further comprise a stabilizer, a solubilizer (glutamic acid, aspartic acid, Polysorbate 80 (registered trademark), or the like), a suspending agent, an emulsifier, a soothing agent, a buffer, a preservative, or the like.
  • injections are sterilized in the final step or produced by aseptic manipulation.
  • the injection may be produced in a form of a sterile solid preparation, for example a lyophilized product, which can be dissolved in sterilized or sterile distilled water for injection or in another sterilized or sterile solvent just before use.
  • food additives generally used in a food or drink may be added, and the examples thereof include a sweetener, a colorant, a preservative, a thickener, an antioxidant, a color improver, a decolorant, an antifungal agent, a gum base, a bittering agent, an enzyme, a brightener, an acidulant, a seasoning, an emulsifier, a fortifier, a processing aid, a flavor, a spice extract, etc.
  • the food or drink includes a health food, a functional food, a food for specified health use, and a food for the sick.
  • the food or drink suitable for the present invention is not particularly limited. Specific examples thereof include so-called dietary supplements, such as a tablet, a granule, a powder, and a health drink. Other examples include drinks, such as tea drink, refreshing drink, soda, nutritional drink, fruit juice, and lactic drink; noodles, such as buckwheat noodle, wheat noodle, Chinese noodle, and instant noodle; sweets and bakery products, such as candy, candy, gum, chocolate, snack, biscuit, jelly, jam, cream, baked goods, and bread; fishery or livestock products, such as fish sausage, ham, and sausage; dairy products, such as processed milk and fermented milk; fats, oils, and processed foods thereof, such as salad oil, oil for frying, margarine, mayonnaise, shortening, whipped cream, and dressing; seasonings, such as sauce and dipping sauce; retort pouch foods, such as curry, stew, sauce for rice-bowl cuisine, porridge, and rice soup; and frozen desserts, such as ice
  • a food or drink prepared with use of the composition may be labeled as improving lipid metabolism; promoting basal metabolism; reducing body weight; reducing visceral fat or subcutaneous fat; having a slimming effect; preventing or treating obesity, or ameliorating a symptom thereof; and/or preventing or treating metabolic syndrome, or ameliorating a symptom thereof.
  • Examples of the feed comprising the composition of the present invention include a feed for livestock such as a cow, a horse, and a pig; a feed for poultry such as a chicken; and a feed for pet animals, such as a dog and a cat.
  • the production of the feed of the present invention needs addition of the composition of the present invention, but other than that, the feed can be produced by an ordinary feed production method.
  • the amount of administration or intake of the medicine or the food or drink of the present invention may be determined depending on the age and body weight of the patient or ingester, symptoms, the administration time, the dosage form, the administration method, the combination of medicines, or the like. For example, preferred is that administration or intake is performed so that 0.05 to 3.0 g, preferably 0.2 to 1.0 g of the component (a) and 0.01 to 0.5 g, preferably 0.05 to 0.3 g of the component (b) are daily given to an adult human. Such a daily amount may be given in a single dose or in several divided doses.
  • Powder ingredients namely, glucosyl hesperidin (0.2 g), caffeine (0.02 g), vitamin C (0.28 g), synthetic aluminum silicate (10 g), potassium hydrogenphosphate (5 g), and lactose (84.5 g) were mixed uniformly to give a powder.
  • Powder ingredients namely, glucosyl hesperidin (0.2 g), caffeine (0.02 g), vitamin C (0.28 g), crystalline cellulose (40.0 g), lactose (35.0 g), starch (19.5 g), and polyvinyl alcohol (5.0 g), and water (30.0 g) were kneaded uniformly, ground and granulated, and then dried to give a granule.
  • Example 2 With 99 g of the granule obtained in Example 2, 1 g of calcium stearate was mixed, and the mixture was compressed with use of a tableting machine to give tablets 6.0 mm in diameter.
  • Extraction from 1 g of a blend of 7 kinds of dried tea leaves, namely, green tea leaves, Job's tears, barley, brown rice, oolong tea leaves, Houttuynia cordata leaves, and Eucommia ulmoides leaves was performed with 100 mL of water.
  • glucosyl hesperidin 100 mg
  • caffeine 10 mg including 2 mg of ingredient-derived caffeine
  • vitamin C 15 mg
  • Brown rice tea extract (1800 mg), lactose (500 mg), citric acid (500 mg), glucosyl hesperidin (550 mg), and caffeine (55 mg including 20 mg of ingredient-derived caffeine) were blended to give a powdered tea.
  • Glucosyl hesperidin 200 mg
  • caffeine (20 mg)
  • citric acid 100 mg
  • vitamin C 15 mg
  • starch syrup 65 g
  • sucrose 10 g
  • maleic acid 300 mg
  • succinic acid 200 mg
  • malic acid 150 mg
  • a flavor 0.3 g
  • a small amount of water were mixed, and then heated and cooled in a conventional method to produce candies.
  • composition of the present invention comprising glucosyl hesperidin and caffeine was investigated.
  • glucosyl hesperidin and caffeine “Hayashibara Hesperidin S (trade name)” (distributor: Hayashibara Co., Ltd.) and “Chanomoto (trade name)” (purity of caffeine: 98.5, made by Shiratori Pharmaceutical Co., Ltd.) were used, respectively.
  • mice Five-week-old male KK mice were fed with water and a powder feed for breeding (CE-2 (trade name), made by CLEA Japan, Inc.) for one week, and then fed with the high-calorie feed (4.70 kcal/g) in Table 1 shown below for 3 weeks for induction of obesity.
  • the mice were divided into 4 groups (a control group, a caffeine administration group, a glucosyl hesperidin administration group, and a present invention administration group (caffeine+glucosyl hesperidin), 5 to 8 mice per group) and fed with the low-calorie feed (3.16 kcal/g) in Table 1 shown below or the low-calorie feed supplemented with the corresponding test sample for 2 weeks, in expectation of using body fat.
  • the feeds given to the test groups are as follows.
  • Compositions of high-calorie feed and low-calorie feed (Unit: mass %) Composition High-calorie feed Low-calorie feed Cornstarch 53.25 53.25 Casein 18.00 18.00 Corn oil 20.00 2.50 Cellulose 2.50 20.00 AIN93G Mineral Mix 1) 5.00 5.00 AIN93 Vitamin Mix 1) 1.00 1.00 Choline bitartrate 0.25 0.25 Calorie (kcal/g) 4.73 3.16 1) Made by Oriental Yeast Co., Ltd.
  • the changes in body weight before and after the test period is shown in FIG. 1
  • the feed intake during the first 10 days of the test period is shown in FIG. 2
  • the weight of mesenteric fat tissue per 100 g of body weight is shown in FIG. 3 .
  • the results are shown as Mean ⁇ SD of each group.
  • the ** and * in the figures indicate a significant difference with a risk less than 1% and a risk less than 5% from the control, respectively.
  • mice Five-week-old male KK mice were fed with water and a powder feed for breeding (CE-2 (trade name), made by CLEA Japan, Inc.) for one week, and then fed with the high-calorie feed (4.70 kcal/g) in Table 1 for 3 weeks for induction of obesity.
  • the mice were divided into 6 groups (a control group, a caffeine administration group, a glucosyl hesperidin administration group, and mixture of caffeine and glucosyl hesperidin (present invention) administration groups, 6 to 7 mice per group) and fed with the low-calorie feed (3.16 kcal/g) in Table 1 or the low-calorie feed supplemented with the corresponding test sample for 2 weeks, in expectation of using body fat.
  • the feeds given to the test groups are as follows.
  • the changes in body weight before and after the test period is shown in FIG. 4
  • the feed intake during the first 10 days of the test period is shown in FIG. 5
  • the weight of subcutaneous fat tissue per 100 g of body weight is shown in FIG. 6
  • the weight of mesenteric fat tissue per 100 g of body weight is shown in FIG. 7 .
  • the results are shown as Mean ⁇ SD of each group.
  • the $, **, and * in the figures indicate a significant difference with a risk less than 10%, a risk less than 1%, and a risk less than 5% from the control, respectively.
  • composition of the present invention comprising a polyphenol containing 15 mass % or more of proanthocyanidin having a polymerization degree of 1 to 3 and caffeine was investigated.
  • polyphenol containing 15 mass % or more of proanthocyanidin having a polymerization degree of 1 to 3 and caffeine “Oligonol (trade name)” (distributor: AMINO UP CHEMICAL Co., Ltd.) and “Chanomoto (trade name)” (purity of caffeine: 98.5%, made by Shiratori Pharmaceutical Co., Ltd.) were used, respectively.
  • mice Five-week-old male KK mice were fed with water and a powder feed for breeding (CE-2 (trade name), made by CLEA Japan, Inc.)
  • mice were divided into 4 groups (a control group, a caffeine administration group, an Oligonol administration group, and a present invention administration group (Oligonol+caffeine), 5 to 8 mice per group) and fed with the low-calorie feed (3.16 kcal/g) in Table 1 or the low-calorie feed supplemented with the corresponding test sample for 2 weeks, in expectation of using body fat.
  • the feeds given to the test groups are as follows.
  • the changes in body weight before and after the test period is shown in FIG. 8
  • the feed intake during the first 10 days of the test period is shown in FIG. 9
  • the total weight of subcutaneous, epididymal, and mesenteric fat tissues per 100 g of body weight is shown in FIG. 10
  • the changes in plasma triglyceride level before and after the test period is shown in FIG. 11 .
  • the results are shown as Mean ⁇ SD of each group.
  • the ** and * in the figures indicate a significant difference with a risk less than 1% and a risk less than 5% from the control, respectively.
  • the present invention administration group showed significantly lower values, i.e., a clear synergistic effect.

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