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WO1999065337A1 - Complement dietetique destine aux femmes menopausees - Google Patents

Complement dietetique destine aux femmes menopausees Download PDF

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Publication number
WO1999065337A1
WO1999065337A1 PCT/US1999/013676 US9913676W WO9965337A1 WO 1999065337 A1 WO1999065337 A1 WO 1999065337A1 US 9913676 W US9913676 W US 9913676W WO 9965337 A1 WO9965337 A1 WO 9965337A1
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WO
WIPO (PCT)
Prior art keywords
vitamin
per day
dietary
dietary supplement
calcium
Prior art date
Application number
PCT/US1999/013676
Other languages
English (en)
Inventor
Stacey J. Bell
Bruce R. Bistrian
R. Armour Forse
Original Assignee
Beth Israel Deaconess Medical Center
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Beth Israel Deaconess Medical Center filed Critical Beth Israel Deaconess Medical Center
Priority to AU45738/99A priority Critical patent/AU4573899A/en
Publication of WO1999065337A1 publication Critical patent/WO1999065337A1/fr

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Classifications

    • 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)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
    • 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
    • A23L33/11—Plant sterols or derivatives thereof, e.g. phytosterols
    • 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
    • A23L33/15—Vitamins
    • 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
    • A23L33/16—Inorganic salts, minerals or trace elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • 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
    • A61K36/06—Fungi, e.g. yeasts
    • 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)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • 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)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
    • A61K36/8998—Hordeum (barley)
    • 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

  • Post-menopausal women are at risk of osteoporosis and coronary heart disease (CHD), among other health conditions.
  • CHD coronary heart disease
  • Proper nutritional support for post menopausal women may mitigate or reduce risk factors that result in disease.
  • Coronary heart disease is a major cause of death in women. It claims tne lives of nearly 250,000 women per year, most of whom are post-menopausal. Although generally not manifest until the post-menopausal stage, CHD develops over decades. Well established risk factors for CHD include elevated plasma cholesterol levels and abnormal glucose metabolism. Also implicated in the development of CHD are elevated homocysteine levels and the effects of free radicals. Phytoestxogens, antioxidants, chromium and folic acid have been shown to mitigate these risk factors.
  • Osteoporosis is associated with the aging process and predominantly affects women. It is characterized by diminished bone density, which results in increased bone fractures and vertebral column collapse. Bone loss begins around about age 35. This loss accelerates during the menopause, which generally occurs around age 45 to 55. Osteoporosis develops over decades and is related to peak bone mass, as well as to the degree of bone loss. Adequate calcium intake limits the development of osteoporosis. Moreover, certain vitamins and minerals enhance calcium absorption and utilization.
  • the invention pertains to a dietary supplement for the purpose of supplementing the micronutrient needs of post-menopausal women for the prevention or reduction of osteoporosis and osteoporetic fractures associated therewith, and coronary heart disease, by retarding bone loss and improving the cardiovascular health of the post-menopausal woman. Bone and cardiovascular health can be maintained by the routine administration of the dietary supplements described herein.
  • a dietary supplement of this invention comprises phytoestrogen, calcium and vitamin D present in amounts sufficient to minimize bone loss in a post- menopausal woman; dietary fiber, vitamin B 12 , vitamin B 6 , and folic acid present in amounts sufficient to reduce total serum cholesterol and low density lipoprotein cholesterol; and optionally physiologically acceptable vehicle(s).
  • the dietary fiber can be any soluble fiber (e.g., derived from yeast or plant, such as oat and barley) that ferments in the colon.
  • the dietary fiber can be ⁇ -glucans which can be soluble in part and insoluble in part, such as whole yeast glucan particles which are most preferred.
  • Members of the isoflavone class of phytoestrogens e.g., genistein, daidzein and glycitein are particularly preferred.
  • the dietary supplements of this invention may be formulated as a tablet, capsule, powder, suspension, gel or liquid, and are preferably formulated for a single or multiple daily administration.
  • the nutritional supplement can be provided in a variety of forms, such as baked goods, puddings, confections, snack foods, ice cream, frozen confections and novelties, dietary beverages, or non-baked extruded foods such as dietary bars.
  • the invention also pertains to methods for supplementing the dietary needs and preventing or reducing health risks associated with bone loss and cardiovascular disease in post-menopausal women.
  • the method comprises administering to a post- menopausal woman an effective amount of the dietary supplement of this invention preferably throughout the remainder of the woman's life, to prevent or reduce bone loss and osteoporotic effects associated therewith; to lower serum cholesterol levels; to reduce levels of low density lipoprotein cholesterol and elevate high density lipoprotein cholesterol; or to prevent or reduce the risk of coronary heart disease.
  • the dietary supplements and the methods of this invention can also be used for women who have defective nonfunctioning ovaries or who lack ovaries since they have similar health risks due to hormonal changes, for instance.
  • the dietary supplement is formulated to supplement the increased nutritional needs of post-menopausal women for the prevention or reduction of the risk of coronary heart disease and osteoporosis throughout this stage of a woman's life.
  • post-menopause as the term is used herein is characterized by complete cessation of ovarian function and an increase in the incidence of osteoporotic fracture and coronary heart disease.
  • the dietary supplemental comprises calcium, vitamin D and phytoestrogens present in amounts sufficient to minimize bone loss in a post-menopausal woman; and vitamin B 12 , vitamin B 6 , folic acid and dietary fiber present in an amount sufficient to reduce total serum cholesterol and low density lipoprotein cholesterol; and optionally in an admixture with physiologically acceptable vehicle(s).
  • a dietary supplement formulated in single or multiple units, provides from about 1 mg to about 2000 mg calcium per day; from about 1 ⁇ g to about 20 ⁇ g vitamin D per day; from about 1 mg to about 100 mg isoflavone per day; from about 1 g to about 50 g ⁇ -glucan per day; from about 1 ⁇ g to about 2000 ⁇ g vitamin B 12 per day; from about 1 mg to about 100 mg vitamin B 6 per day; and from about 1 ⁇ g to about 1000 ⁇ g folic acid per day.
  • a dietary supplement in single or multiple units, provides from about 500 mg to about 1500 mg calcium per day; from about 5 ⁇ g to about 13 ⁇ g vitamin D per day; from about 20 mg to about 60 mg isoflavone per day; from about 1.5 ⁇ g to about 4.0 ⁇ g vitamin B 12 per day; from about 1.6 mg to about 4.6 mg vitamin B 6 per day; and from about 180 ⁇ g to about 800 ⁇ g folic acid per day.
  • the invention also pertains to a method for supplementing the dietary needs and preventing or reducing life stage associated health risks in post-menopausal women.
  • This method comprises administering (preferably on a daily basis) to a post-menopausal woman an "effective amount" of the dietary supplement of the invention throughout that life stage.
  • effective amount means an amount of the dietary supplement and components contained therein (e.g., either singly or in combination) sufficient to achieve a desired effect, i.e., to prevent or reduce certain health risks in post-menopausal women.
  • the methods of this invention and the term "effective amount" is intended to embrace therapeutic and prophylactic treatment.
  • the dietary supplements of this invention are not meant to replace a well-balanced diet, but are instead intended to supplement a prudent diet. Unlike known broad-based dietary supplements, this invention does not merely provide the prescribed Recommended Daily Allowance (RDA) of micronutrients, but rather is geared to emphasize the disease prevention properties of micronutrient supplementation. Thus, cumulative beneficial and preventive effects should be achieved by dietary supplementation with the appropriate dietary supplement of the invention.
  • RDA Recommended Daily Allowance
  • the dietary supplements of this invention contain vitamins, minerals and other compounds that are specifically included in effective amounts to address common health concerns that arise during post-menopause. Moreover, the dietary supplements are formulated to prevent or to lessen the risk of osteoporosis, osteoporotic fractures associated therewith, and coronary heart disease, which are generally manifest in the post-menopause life stage.
  • the dietary supplement and the methods of this invention can also be used for women who lack ovaries or who have defective, nonfunctioning ovaries (e.g., hormone levels below normal).
  • the presence of calcium and vitamin D in the dietary supplement of this invention is intended to retard the rate at which bone degrades, thereby minimizing the onset and debilitating effects of osteoporosis.
  • Osteoporosis is the nonvolitional loss of bone that results in an increased susceptibility to fracture, especially of the wrist, lumbar spine and hip region.
  • At menopause there is an increase in the amount of calcium lost in the urine (Christopher, B.E., "Calcium and Osteoporosis", Nutrition 75:664-686 (1997).
  • the absorption of calcium may be diminished.
  • the amount of calcium included in the dietary supplements of this invention will depend, in part, on the physical and nutritional condition of the post- menopausal woman, whether the individual is undergoing hormone replacement therapy, as well as the type of calcium used.
  • the amount of calcium will be from about 1 to about 2,000 mg per day; preferably 500 to 1,500 mg per day, with 1,200 mg being optimal as recommended by the Institute of Medicine in the Dietary Reference Intake Guideline of 1997.
  • the calcium may be derived from calcium carbonate, calcium citrate, calcium phosphate, calcium maleate, calcium lactate maleate, calcium lactate-gluconate, or a combination thereof; with calcium citrate or calcium maleate being most preferred.
  • Vitamin D (1,25-dihydroxyvitamin D 3 ) when administered with calcium or calcitonin has been shown to prevent bone loss in women who had a prolonged use of corticosteroids, which had led to bone loss in the lumbar spine (Sambrook et al., N. Engl. J. Med., 328:1141-52 (1993)).
  • Vitamin D is incorporated in the dietary supplement as vitamin D 2 (ergocholecaliferol), vitamin D 3 (cholecalciferol, calcitriol), calcifediol [25(OH)] or combination thereof.
  • the dietary supplement should provide from about 1 to about 20 micrograms per day of vitamin D; preferably from about 5 to about 13 micrograms per day (400 to 800 I.U.). Most preferably, vitamin D will be present in the dietary supplement in the recommended daily allowance (RDA) of about 5 micrograms per day.
  • RDA recommended daily allowance
  • Phytoestrogens and more particularly isofiavones are included in the dietary supplements of this invention. These compounds have been demonstrated by clinical trials to modulate the menstrual cycle, reduce menopausal symptoms, and lower LDL cholesterol (LDL-C) levels. J. Nutr., 1996, 126(1): 161-7; N. Engl. J. Med., 1995, 333:276-82. Epidemiologic observations indicate women in countries where diets are high in phytoestrogen (averaging about 40-50 mg/day) have a decreased incidence of breast cancer, menopausal symptoms and osteoporosis. Nutr. Cancer, 1994, 21 :113-131 ; J. Nutr., 1995, 125; 151S-110S; Am.
  • Isofiavones or isoflavanoids are a class of phytoestrogens derived from plants, commonly soy beans. The plant source is not critical, however, soybeans are an excellent source of isofiavones and are particularly abundant in genistein.
  • phytoestrogens such as genistin, glycitin and diadzin contain a glycosidic moiety, whereas other phytoestrogens are nonglycosylated, genistein, glycitein and diadzein.
  • Phytoestrogens obtained from a single plant generally are a mixture of both glycosylated and nonglycosylated forms.
  • the dietary supplements of the invention generally contain a mixture of phytoestrogens; however, purified phytoestrogens may be used.
  • Daidzein is a metabolite of ipriflavone which has been shown to increase bone mass.
  • Soy isofiavones have estrogenic effects, which are mediated through estrogen receptors.
  • Soy isofiavones are weaker than estradiol and diethylstilbestrol.
  • genistein is known to be an estrogen analog and will bind to estrogen receptors with the affinity of 0.2% of estradiol, the major circulating estrogen (Erdman JW, Potter SM. Soy and bone health. The Soy Connection volume 5, 1997).
  • the isofiavones have antiestrogenic effects rather than estrogenic effects. It usually depends upon the particular tissue how the isofiavones behaves. In the case of bone, isofiavones have estrogenic action or are estrogen agonists and should improve bone health.
  • the isoflavone genistein
  • tyrosine kinase an enzyme important in the mechanism leading to platelet aggregation and blood clotting. Ingestion of this isoflavone or soy protein may help to decrease thrombosis and prevent mortality from cardiovascular disease (Kurowska EM. Soy and reduced risk of cardiovascular disease. The Soy Connection, vol. 5, page 1, 1997).
  • Soy may also prevent breast cancer and hot flashes that occur during menopause.
  • Genistein and diadzein have been shown to inhibit human breast cancer and prostate cancer cell lines in cultures by mechanisms independent of steroid binding (ADM, Technical Report, 1998).
  • Isofiavones may exert their effect by inhibiting tumor growth and inducing cell maturation.
  • Chinese women who are pre- menopausal have a reduced incidence of breast cancer compared to women in other cultures where soy is not consumed regularly. This phenomenon has been shown to be true for women in Australia who eat a high soy diet and women in other parts of Southeast Asia.
  • phytoestrogen levels of from about 1 to about 100 mg per day, preferably from about 20 to about 60 mg per day, and most preferably about 50 mg per day, provide women with phytoestrogen levels that are physiologically effective and may be used to supplement women's micronutrient needs during post-menopause.
  • the phytoestrogen can be selected from the group consisting of genistin, glycitin, diadzin, genistein, glycitein, diadzein and combinations thereof.
  • a preferred mixture of phytoestrogen may be obtained commercially such as Novasoy (genistein: daidzein: glycitein in a ratio of 1.1 : 1 :0.2) from Archer Daniels Midland (ADM). DIETARY FIBER
  • Dietary fiber suitable for reducing total serum cholesterol and low density lipoprotein cholesterol is also incorporated in the dietary supplement of the present invention.
  • the dietary fiber can be any soluble fiber (e.g., derived from yeast or plant, such as oat and barley) that ferments in the colon.
  • suitable dietary fiber include but are not limited to, nondigestible polysaccharides, plant cell walls, carageenans, mucilages, glucans (e.g., ⁇ -glucans), gums, agar, some hemicelluloses, psyllium and pectin.
  • the dietary fiber can be a ⁇ - glucan which is soluble in part and insoluble in part, such as whole yeast glucan particles which are most preferred.
  • Yeast ⁇ -glucan has been shown to reduce serum cholesterol and LDL-C concentrations and raise high density lipoprotein cholesterol levels. See U.S. Patent No. 4,962,094; the entire teachings of which are incorporated herein by reference.
  • Hypercholesterolemic subjects > 240 mg/dL
  • Subjects received 15 grams of yeast ⁇ -glucan (FibercelTM, Alpha-Beta Technology, Inc.; whole yeast glucan particles having an in vivo glucan morphology ) in orange juice for eight weeks.
  • the amount of dietary fiber included in the dietary supplement of this invention will vary depending upon the source and type of fiber incorporated therein, but in any event, should be an amount sufficient to reduce total serum cholesterol and low density lipoprotein cholesterol.
  • Dietary fiber can be incorporated into the dietary supplement in amounts of from about 1 g to about 50 gm day; with preferably from about 5 g to about 20 gm/day; most preferably 15 gm day.
  • a particularly preferred dietary is yeast ⁇ -glucan, such as that described in U.S. Patent No. 4,962,094 (FibercelTM).
  • Vitamin B 12 (cyanocobalamin), vitamin B 6 (pyridoxine) and folic acid are included in the dietary supplement of this invention. These elements act synergistically to reduce serum homocysteine; high levels of which are associated with coronary heart disease.
  • the amount of vitamin B 12 is from about 1 to about 2,000 mg/day, preferably from about 1.5 to about 4.0 ⁇ g/day, with 2.0 ⁇ g/day being optimal.
  • Folic acid is provided in the dietary supplement as it has been shown to have beneficial cardiac effects and to decrease the risk of cervical dysplasia. Scand. J. Clin. Lab Invest., 1988, 48:215-221.
  • the dietary supplements of the invention are intended to be orally administered daily. Preferably, they are formulated for single daily administration, but may be formulated in multiple portions or as time release compositions for more or less frequent administration; for example, the dietary supplement may be formulated as two tablets for twice daily administration. For reasons of size (ease of swallowing) or improved bioabsorption or utilization (e.g., before or after a meal or before sleep), a given dosage may be divided into two, three, or more tablets (or capsules, etc.). A daily dosage may be administered as one tablet, as two tablets taken together, or as two tablets taken separately (e.g., one in the morning and one in the evening).
  • the recommended daily amounts of each ingredient, as described above, serve as a guideline for formulating the dietaiy supplements of this invention.
  • the actual amount of each ingredient per unit dosage will depend upon the number of units daily administered to the post-menopausal woman. This is a matter of product design and is well within the skill of the dietary supplement formulator.
  • the dietary supplements of the present invention may be formulated using any pharmaceutically acceptable forms of the vitamins, minerals and other nutrients discussed above, including their salts. They may be formulated into capsules, tablets, powders, suspensions, gels or liquids optionally comprising a physiologically acceptable carrier, such as but not limited to water, milk, juice, starch, vegetable oils, salt solutions, hydro xym ethyl cellulose, carbohydrate.
  • the dietary supplements may be formulated as powders, for example, for mixing with consumable liquids, such as milk, juice, water or consumable gels or syrups for mixing into other dietary liquids or foods.
  • the dietary supplements of this invention may be formulated with other foods or liquids to provide premeasured supplemental foods, such as single servings bars, for example.
  • the dietary supplement can be made in a variety of forms, such as baked goods, (e.g., cookies, brownies, fudge, cake, breads, biscuits, crackers,), puddings, confections, (i.e., candy), snack foods (e.g., pretzels, chips), dietary beverages, ice cream, frozen confections and novelties, or non-baked, extruded food products such as bars.
  • baked goods e.g., cookies, brownies, fudge, cake, breads, biscuits, crackers
  • puddings e.g., candy
  • snack foods e.g., pretzels, chips
  • dietary beverages e.g., ice cream, frozen confections and novelties
  • non-baked extruded food products such as bars.
  • the preferred form is a non-baked extruded nutritional bar.
  • the dietary supplement can also contain other ingredients such as one or a combination of other vitamins, minerals, antioxidants, fiber and other dietary supplements. Selection of one or several of these ingredients is a matter of formulation design, consumer and end-user preference .
  • the amount of these ingredients added to the dietary supplements of this invention are readily known to the skilled artisan and guidance to such amounts can be provided by the U.S. RDA doses for children and adults.
  • Vitamins and minerals that can be added include, but are not limited to, calcium phosphate or acetate, tribasic; potassium phosphate, dibasic; magnesium sulfate or oxide; salt (sodium chloride); potassium chloride or acetate; ascorbic acid; ferric orthophosphate; niacinamide; zinc sulfate or oxide; calcium pantothenate; copper gluconate; riboflavin; beta-carotene; pyridoxine hydrochloride; thiamin mononitrate; folic acid; biotin; chromium chloride or picolonate; potassium iodide; sodium selenate; sodium molybdate; phylloquinone; Vitamin D 3 ; cyanocobalamin; sodium selenite; copper sulfate; Vitamin A; Vitamin E; vitamin B 6 and hydrochloride thereof; Vitamin C; inositol; Vitamin B 12 ; potassium iodide.
  • the dietary supplement can comprise one or a combination of antioxidants in therapeutic amounts.
  • Antioxidants suitable for use in this invention include but are not limited to, vitamin, A, vitamin C, vitamin E, ⁇ -carotene, zinc, chromium, selenium and herbs, such as ginkgo biloba, ginseing.
  • the amount of antioxidant(s) per unit serving are a matter of design and will depend upon the total number of unit servings of the dietary supplement daily administered to the patient. The total amount of antioxidant(s) will also depend, in part, upon the condition of the patient. Preferably the amount of antioxidant(s) will be a fraction or multiplier of the RDA amounts.
  • the dietary supplement will comprise 50% RDA antioxidants per unit dosage and the patient will consume two units per day.
  • Flavors, coloring agents, spices, nuts and the like can be incorporated into the product.
  • Flavorings can be in the form of flavored extracts, volatile oils, chocolate flavorings, peanut butter flavoring, cookie crumbs, crisp rice, vanilla or any commercially available flavoring.
  • useful flavorings include but are not limited to pure anise extract, imitation banana extract, imitation cherry extract, chocolate extract, pure lemon extract, pure orange extract, pure peppermint extract, imitation pineapple extract, imitation rum extract, imitation strawberry extract, or pure vanilla extract; or volatile oils, such as balm oil, bay oil, bergamot oil, cedarwood oil, cherry oil, walnut oil, cinnamon oil, clove oil, or peppermint oil; peanut butter, chocolate flavoring, vanilla cookie crumb, butterscotch or toffee.
  • the dietary supplement contains cocoa ro chocolate.
  • Emulsifiers may be added for stability of the final product.
  • suitable emulsifiers include, but are not limited to, lecithin (e.g., from egg or soy), and/or mono- and di-glycerides.
  • Other emulsifiers are readily apparent to the skilled artisan and selection of suitable emulsifier(s) will depend, in part, upon the formulation and final product.
  • Preservatives may also be added to the dietary supplement to extend product shelf life.
  • preservatives such as potassium sorbate, sodium sorbate, potassium benzoate, sodium benzoate or calcium disodium EDTA are used.
  • the dietary supplement can contain artificial sweeteners, e.g., saccharides, cyclamates, aspartamine, aspartame, acesulfame K, and/or sorbitol.
  • artificial sweeteners e.g., saccharides, cyclamates, aspartamine, aspartame, acesulfame K, and/or sorbitol.
  • Such artificial sweeteners can be desirable if the dietary supplement is intended for an overweight or obese individual, or an individual with type II diabetes who is prone to hyperglycemia.
  • the liquid ingredients are cooked; the dry ingredients are added with the liquid ingredients in a mixer and mixed until the dough phase is reached; the dough is put into an extruded, and extruded; the extruded dough is cut into appropriate lengths; and the product is cooled.
  • the ingredients comprising the dietary supplement of this invention can be added to traditional formulations or they can be used to replace traditional ingredients. Those skilled in food formulating will be able to design appropriate foods/beverages with the objective of this invention in mind.

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Abstract

Selon l'invention, l'administration systématique des compléments diététiques décrits ici permet de conserver en bonne santé les os et le système cardio-vasculaire. Un complément diététique de l'invention comprend du calcium, un phyto-oestrogène et de la vitamine D, en doses suffisantes pour minimiser la perte osseuse chez la femme ménopausée, ainsi que des fibres diététiques, de la vitamine B12, de la vitamine B6 et de l'acide folique en doses suffisantes pour réduire le cholestérol sérique total et le cholestérol des LDL. L'invention concerne ce complément diététique ainsi que des méthodes, utiles chez les femmes ayant subi une ovariectomie ou dont le fonctionnement des ovaires est défectueux.
PCT/US1999/013676 1998-06-19 1999-06-16 Complement dietetique destine aux femmes menopausees WO1999065337A1 (fr)

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Application Number Priority Date Filing Date Title
AU45738/99A AU4573899A (en) 1998-06-19 1999-06-16 Dietary supplement for post-menopausal women

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US10038898A 1998-06-19 1998-06-19
US09/100,388 1998-06-19

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Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000049896A1 (fr) * 1999-02-24 2000-08-31 Geza Bruckner Compositions et procedes dietetiques
WO2001070212A2 (fr) * 2000-03-23 2001-09-27 Interhealth Nutraceuticals Incorporated Methode et composition permettant de prevenir et de diminuer les symptomes de la menopause
EP1155699A1 (fr) * 2000-05-15 2001-11-21 Laboratorios Biosinética Ltda Compositions pharmaceutiques et nutritionelles contenant de l' acide folique, phytosteroles, cyanocobalamine, pyridoxine et fibres alimentaires
WO2002076481A1 (fr) * 2001-03-26 2002-10-03 Niazi Sarfaraz K Composition et procede s'utilisant dans le traitement de dysfonctionnements sexuels au moyen d'inhibiteurs de phosphodiesterase de type 5 specifiques de gmp cyclique
WO2003011263A2 (fr) * 2001-07-20 2003-02-13 S.K. Enterprise Gmbh Utilisation d'un sel de lactate pour le traitement et la prophylaxie de l'atherosclerose
WO2003070255A1 (fr) * 2002-02-21 2003-08-28 Schering Aktiengesellschaft Compositions pharmaceutiques contenant un ou plusieurs steroides, un ou plusieurs tetrahydrofolates et de la vitamine b12
EP1514540A1 (fr) * 2002-05-01 2005-03-16 Kabushiki Kaisha Hayashibara Seibutsu Kagaku Kenkyujo Agents de renforcement de tissus contenant du calcium et utilisation correspondante
DE102005022953A1 (de) * 2005-05-19 2006-11-23 Chemische Fabrik Budenheim Kg Nahrungsergänzungsmittel
WO2007100671A2 (fr) 2006-02-28 2007-09-07 Nestec S.A. Compositions et méthodes pour induire une croissance osseuse et inhiber une perte osseuse
WO2008057738A1 (fr) * 2006-10-27 2008-05-15 Sciele Pharma, Inc. Compositions contenant des isoflavones pour le traitement de l'ostéoporose et de maladies inflammatoires des articulations
US7687485B2 (en) 1999-09-30 2010-03-30 Drug Tech Corporation Formulation for menopausal women
US20100139524A1 (en) * 2008-12-10 2010-06-10 Taipei Medical University Novel amorphous metal salt for facilitating the handling property of portland cements and dental applications thereof
ES2343294A1 (es) * 2008-10-22 2010-07-27 Farmalider, S.A. Composicion farmaceutica en forma solida que contiene isoflavonas, una sal de calcio y vitamina d3.
CN103082297A (zh) * 2013-02-05 2013-05-08 山西振东五和健康食品股份有限公司 增加骨密度及关节保健的食品及其制备方法
US9216160B2 (en) 2011-10-05 2015-12-22 Jeffrey M. Golini Choline composition
ITUB20153328A1 (it) * 2015-09-01 2017-03-01 Akademy Pharma S R L Composto nutraceutico contro i sintomi della menopausa

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US5603936A (en) * 1995-02-15 1997-02-18 Richard A. Ratcliff Process for removing light absorbing compounds from epidermal plant cells
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Cited By (30)

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US6359017B1 (en) 1999-02-24 2002-03-19 Geza Bruckner Dietary compositions and methods
WO2000049896A1 (fr) * 1999-02-24 2000-08-31 Geza Bruckner Compositions et procedes dietetiques
US7687485B2 (en) 1999-09-30 2010-03-30 Drug Tech Corporation Formulation for menopausal women
WO2001070212A2 (fr) * 2000-03-23 2001-09-27 Interhealth Nutraceuticals Incorporated Methode et composition permettant de prevenir et de diminuer les symptomes de la menopause
WO2001070212A3 (fr) * 2000-03-23 2002-05-23 Interhealth Nutraceuticals Inc Methode et composition permettant de prevenir et de diminuer les symptomes de la menopause
EP1155699A1 (fr) * 2000-05-15 2001-11-21 Laboratorios Biosinética Ltda Compositions pharmaceutiques et nutritionelles contenant de l' acide folique, phytosteroles, cyanocobalamine, pyridoxine et fibres alimentaires
WO2002076481A1 (fr) * 2001-03-26 2002-10-03 Niazi Sarfaraz K Composition et procede s'utilisant dans le traitement de dysfonctionnements sexuels au moyen d'inhibiteurs de phosphodiesterase de type 5 specifiques de gmp cyclique
US7358277B2 (en) 2001-07-20 2008-04-15 S.K. Enterprise Gmbh Use of a lactate salt for the treatment and prophylaxis of atherosclerosis
WO2003011263A2 (fr) * 2001-07-20 2003-02-13 S.K. Enterprise Gmbh Utilisation d'un sel de lactate pour le traitement et la prophylaxie de l'atherosclerose
WO2003011263A3 (fr) * 2001-07-20 2003-12-18 S K Entpr Gmbh Utilisation d'un sel de lactate pour le traitement et la prophylaxie de l'atherosclerose
WO2003070255A1 (fr) * 2002-02-21 2003-08-28 Schering Aktiengesellschaft Compositions pharmaceutiques contenant un ou plusieurs steroides, un ou plusieurs tetrahydrofolates et de la vitamine b12
EA007599B1 (ru) * 2002-02-21 2006-12-29 Шеринг Акциенгезельшафт Фармацевтические композиции, содержащие один или несколько стероидов, один или несколько тетрагидрофолатных компонентов и витамин в
AU2002343249B2 (en) * 2002-02-21 2009-02-05 Bayer Schering Pharma Aktiengesellschaft Pharmaceutical compositions comprising one or more steroids one or more tetrahydrofolate components and vitamin B12
EP1514540A4 (fr) * 2002-05-01 2006-03-08 Hayashibara Biochem Lab Agents de renforcement de tissus contenant du calcium et utilisation correspondante
EP1514540A1 (fr) * 2002-05-01 2005-03-16 Kabushiki Kaisha Hayashibara Seibutsu Kagaku Kenkyujo Agents de renforcement de tissus contenant du calcium et utilisation correspondante
US8778882B2 (en) 2002-05-01 2014-07-15 Hayashibara Co., Ltd. Agent for strengthening calcium containing tissue and use thereof
DE102005022953A1 (de) * 2005-05-19 2006-11-23 Chemische Fabrik Budenheim Kg Nahrungsergänzungsmittel
EP1988891A4 (fr) * 2006-02-28 2011-06-22 Nestec Sa Compositions et méthodes pour induire une croissance osseuse et inhiber une perte osseuse
WO2007100671A2 (fr) 2006-02-28 2007-09-07 Nestec S.A. Compositions et méthodes pour induire une croissance osseuse et inhiber une perte osseuse
EP1988891A2 (fr) * 2006-02-28 2008-11-12 Nestec S.A. Compositions et méthodes pour induire une croissance osseuse et inhiber une perte osseuse
US8242100B2 (en) 2006-02-28 2012-08-14 Nestec Sa Compositions and methods for inducing bone growth and inhibiting bone loss
WO2008057738A1 (fr) * 2006-10-27 2008-05-15 Sciele Pharma, Inc. Compositions contenant des isoflavones pour le traitement de l'ostéoporose et de maladies inflammatoires des articulations
ES2343294B1 (es) * 2008-10-22 2011-06-20 Farmalider, S.A. Composicion farmaceutica en forma solida que contiene isoflavonas, una sal de calcio y vitamina d3.
ES2343294A1 (es) * 2008-10-22 2010-07-27 Farmalider, S.A. Composicion farmaceutica en forma solida que contiene isoflavonas, una sal de calcio y vitamina d3.
US8298328B2 (en) * 2008-12-10 2012-10-30 Taipei Medical University Amorphous metal salt for facilitating the handling property of portland cements and dental applications thereof
US20100139524A1 (en) * 2008-12-10 2010-06-10 Taipei Medical University Novel amorphous metal salt for facilitating the handling property of portland cements and dental applications thereof
US9216160B2 (en) 2011-10-05 2015-12-22 Jeffrey M. Golini Choline composition
CN103082297A (zh) * 2013-02-05 2013-05-08 山西振东五和健康食品股份有限公司 增加骨密度及关节保健的食品及其制备方法
ITUB20153328A1 (it) * 2015-09-01 2017-03-01 Akademy Pharma S R L Composto nutraceutico contro i sintomi della menopausa
EP3138562A1 (fr) * 2015-09-01 2017-03-08 Akademy Pharma S.r.l. Composé nutraceutique contre les symptômes menopausiques

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