WO2006017551A1 - Composition and method of promoting weight loss, fat loss or modulation of metabolic rate - Google Patents

Composition and method of promoting weight loss, fat loss or modulation of metabolic rate Download PDF

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Publication number
WO2006017551A1
WO2006017551A1 PCT/US2005/027518 US2005027518W WO2006017551A1 WO 2006017551 A1 WO2006017551 A1 WO 2006017551A1 US 2005027518 W US2005027518 W US 2005027518W WO 2006017551 A1 WO2006017551 A1 WO 2006017551A1
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Prior art keywords
composition
vitamin
source
chromium
bioavailable
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PCT/US2005/027518
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French (fr)
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John L. Zenk
John Dykstra
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Humanetics Corporation
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Priority to AU2005271536A priority Critical patent/AU2005271536B2/en
Publication of WO2006017551A1 publication Critical patent/WO2006017551A1/en

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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
    • A61K31/28—Compounds containing heavy metals
    • 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
    • A61K33/24—Heavy metals; Compounds 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
    • A61K31/335—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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
    • A61K31/5685—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone having an oxo group in position 17, e.g. androsterone
    • 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
    • A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • 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
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/82—Theaceae (Tea family), e.g. camellia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca

Definitions

  • the invention relates to dietary supplements and dietary supplements effective for promoting weight loss, fat loss or modulation of the basal metabolic rate of a dieting mammal.
  • Excessive body fat is a widespread problem. Excessive body fat can be unappealing, often resulting in reduced self-esteem, and can negatively impact an individual's interest and enjoyment of various physical activities.
  • a vast number of products and programs have been developed to assist persons in achieving fat loss - with or without concomitant weight loss. However, as with such products and programs directed to weight loss, the vast majority of these products and programs have produced limited success due primarily to an underlying inability of the product or program to promote fat loss and/or an inability of the participant to continue with the product or program due to the significant lifestyle change required to achieve and sustain fat loss with the product or program.
  • BMR basal metabolic rate
  • the steroid ⁇ 5-androstene-3-ol-7, 17-dione (7-oxo DHEA) is believed to stimulate various beneficial biological responses including (i) inducing the synthesis of various thermogenic enzymes which are effective for regulating metabolism and thereby promoting weight control without affecting caloric intake, and (ii) inducing the synthesis of the major thyroid hormone triiodothyronine (T 3 ) which is effective for increasing the basal metabolic rate and thereby promoting weight control without affecting caloric intake.
  • T 3 major thyroid hormone triiodothyronine
  • thermogenesis conversion of foodstuffs to heat energy rather than chemical energy such as ATP and/or triacylglycerides.
  • thermogenic effect mediated by 7-oxo DHEA is believed to result from the ability of 7-oxo DHEA to stimulate the synthesis of thermogenic enzymes including mitochondrial glycerol 3-phosphate dehydrogenase (G3P-DH), cytosolic malic enzyme (ME) and fatty acyl CoA oxidase.
  • G3P-DH mitochondrial glycerol 3-phosphate dehydrogenase
  • ME cytosolic malic enzyme
  • fatty acyl CoA oxidase fatty acyl CoA oxidase
  • Chromium is an essential trace mineral for the human body. It is important in processing carbohydrates and fats, and it helps cells respond properly to insulin. Based upon these biological effects of chromium, it has been suggested that chromium may be effective for promoting weight loss and/or improving lean body mass.
  • chromium may be effective for promoting weight maintenance, weight loss and/or fat loss, a continuing need exists for achieving accelerated weight loss and accelerated fat loss.
  • Calcium is an essential mineral which builds and strengthens bones and teeth, maintains normal heart beat and regulates blood pressure. Calcium is also essential for the healthy functioning of the nerve system.
  • Green tea is the natural dried leaves of the tea plant, Camelia sinensis. Black tea is oxidized green tea. Green tea, unlike black tea, is not fermented and therefore contains the original active constituents of the leaves. Green tea is rich in bioflavonoids, compounds that help fight damaging free radicals, including polyphenols such as Epigallocatechin Gallate (EGCG). Green tea extract is an incredibly powerful antioxidant, which makes it a benefit to both immune and circulatory health. It is also generally believed that green tea extract may support weight loss and fat loss by increasing energy expenditure.
  • EGCG Epigallocatechin Gallate
  • green tea extract may be effective for promoting weight loss or fat loss, a continuing need exists for achieving accelerated weight loss and/or accelerated fat loss.
  • vitamin C also known as ascorbic acid, promotes the absorption of chromium.
  • vitamin C can promote weight loss and/or improve lean body mass as chromium- once absorbed - can promote weight loss and/or improve lean body mass.
  • vitamin C may be effective for promoting weight loss and/or improve lean body mass, a continuing need exists for achieving accelerated weight loss and/or accelerated fat loss.
  • the vitamin D group including vitamin D, vitamin D 2 and vitamin D 3 ,also known as cholecalciferol, promotes the absorption of calcium.
  • the vitamin D group can promote fat loss as calcium - once absorbed - can increase the amount of fat that the body uses for fuel.
  • vitamin D group may be effective for promoting weight loss and/or fat loss by promoting the absorption of calcium, a continuing need exists for achieving accelerated weight loss and accelerated fat loss.
  • Weight loss, fat loss and modulation of the BMR of a dieting mammal may be achieved by administering a composition including at least (i) 7-oxo DHEA or a pro-drug thereof incapable of in vivo conversion to testosterone, (ii) a source of bioavailable chromium, (iii) a source of bioavailable calcium, (iv) Green Tea extract, (v) vitamin C, and (vi) at least one vitamin from the vitamin D group.
  • bioavailable means capable of being absorbed or becoming available at the site of physiological activity after administration.
  • the term “elemental calcium” means calcium (Ca) alone, without regard or reference to any other element or chemical moiety to which the calcium may be bonded or attached.
  • the term "elemental chromium” means chromium (Cr) alone, without regard or reference to any other element or chemical moiety to which the chromium may be bonded or attached.
  • the term “dieting” means eating and drinking sparingly with the intent to lose weight.
  • 7-oxo BHEA means ⁇ 5- androstene-3-ol-7, 17-dione.
  • 3-acetyl 7-oxo DHEA means ⁇ 5-androstene-3-acetoxy-7, 17-dione.
  • compositions including at least (i) 7-oxo DHEA or a pro-drug thereof incapable of in vivo conversion to testosterone, and (ii) a source of bioavailable calcium is synergistically effective for promoting weight loss and fat loss, particularly when combined with dieting.
  • dieting is an ineffective means for achieving weight loss because the body reacts to the reduced caloric intake by slowing down the metabolism of the dieter.
  • a composition including at least 7-oxo DHEA and a source of bioavailable calcium is synergistically effective for modulating the metabolism of a dieting mammal so as to prevent or at least moderate any diet-induced decrease in metabolism. Such moderation of the metabolism should be effective for accelerating the weight loss achievable by dieting.
  • the composition includes at least (i) 7-oxo DHEA or a pro-drug thereof incapable of in vivo conversion to testosterone, (ii) a source of bioavailable chromium, (iii) a source of bioavailable calcium, (iv) Green Tea extract, (v) vitamin C, and (vi) at least one vitamin from the vitamin D group.
  • the composition should include about 0.1 to 80 wt%, preferably about 5 to 10 wt% 7-oxo DHEA or a pro-drug thereof incapable of in vivo conversion to testosterone, a trace amount (typically 50 to 250 ⁇ g per daily dose) elemental chromium, about 1 to 90 wt%, preferably 20 to 40 wt% elemental calcium, about 0.1 to 80 wt%, preferably 20 to 40 wt% Green Tea extract, 0.1 to 90 wt%, preferably 20 to 40 wt% vitamin C and a trace amount (typically 10 to 50 ⁇ g per daily dose) vitamin D 3 .
  • a trace amount typically 50 to 250 ⁇ g per daily dose
  • elemental chromium about 1 to 90 wt%, preferably 20 to 40 wt% elemental calcium
  • about 0.1 to 80 wt% preferably 20 to 40 wt% Green Tea extract
  • 0.1 to 90 wt% preferably 20 to 40 wt% vitamin C
  • Selection of the most advantageous ratio of these ingredient to achieve the desired biological effect e.g., weight loss, prevention of weight gain, fat loss, prevention of fat gain, etc.
  • a defined group e.g., males, females, young adults, senior citizens, etc.
  • dose and dose rate e.g., once daily, with each meal
  • 7-oxo DHEA is a derivative of dehydroepiandrosterone (DHEA). 7-oxo DHEA does not appreciably stimulate, increase or otherwise enhance the production of sex hormones.
  • the steroid is commercially available from a number of sources including Steraloids, Inc. of Wilton, New Hampshire. A number of procedures are available for synthesizing ⁇ 5-androstene-3 ⁇ -ol-7,17 dione from DHEA, with one such procedure described in United States Patent No. 5,296,481.
  • Pro-drugs of 7-oxo DHEA ⁇ i.e., compounds readily metabolized in vivo to the active 7-oxo DHEA
  • 7-oxo DHEA pro ⁇ drug is the commercially available ⁇ 5-androstene-3 ⁇ -acetyl-7,17 dione (3-acetyl 7-oxo DHEA).
  • the 3 ⁇ -acetyl group is hydrolyzed in vivo by esterases located in the blood and various tissue to produce the active 7-oxo DHEA, and is believed to be less susceptible to oxidation during the manufacturing process relative to 7-oxo DHEA.
  • pro ⁇ drugs include ⁇ 5-androstene-3 ⁇ , 17 ⁇ -diol-7-one, ⁇ 5-androstene-3 ⁇ , 7 ⁇ -diol-17-one, ⁇ 5- androstene-3 ⁇ , 7 ⁇ -diol-17-one and the corresponding esters, ethers and carbonates of these steroids.
  • chromium picolinate is commercially available from Nutrition 21 of Purchase, New York.
  • Calcium is found in milk and other dairy products such as cheese and yogurt. Calcium is also found in dark green vegetables and dried beans. A variety of compounds containing bioavailable calcium are known and commercially available, including calcium citrate, calcium carbonate, calcium gluconate, calcium lactate, dolomite, bone meal, oyster shell, and coral calcium. By way of example, calcium carbonate is commercially available the J.M. Huber Corporation of Edison, New Jersey.
  • Green Tea extract is well known in the art.
  • green tea leaves are typically extracted with hot or cold water to form a solution containing tea catechins and caffeine.
  • This green tea solution may be further concentrated to form either a concentrated extract solution or a dry powder.
  • the extract solution or the powder may contain stabilizers, such as food-approved acids, e.g. citric acid, ascorbic acid, isoascorbic acid, and the like.
  • Green tea extract powders are commercially available from a number of sources, including Guizhou Highyin Biological Product Co., Guiyang, P.R. China, or Zhejang Zhongke Plant Technical Co. Ltd., Hangzhou, Zhejang, P.R. China.
  • a preferred green tea extract is one containing a high concentration of epigallocatechin gallate (EGCG) and a minimal concentration of caffeine or is a caffeine-free extract.
  • EGCG epigallocatechin gallate
  • Vitamins C and the vitamins in the vitamin D group are well known essential nutrients widely available from a number of sources.
  • composition can be administered by virtually any of the commonly accepted practices for the administration of pharmaceutical preparations including specifically, but not exclusively, mucosal administration, oral consumption, ocular administration, subcutaneous injection, transdermal administration, etc. Oral administration is generally preferred.
  • Mucosal administration of the metabolic modulating agent includes such routes as buccal, endotracheal, nasal, pharyngeal, rectal, sublingual, vaginal, etc.
  • the metabolic modulating agent may be formulated as an emulsion, gum, lozenge, spray, tablet or an inclusion complex such as cyclodextrin inclusion complexes.
  • Nasal administration is conveniently conducted through the use of a sniffing powder or nasal spray.
  • the metabolic modulating agent may be formulated as a cream, douche, enema or suppository.
  • Oral consumption of the metabolic modulating agent may be effected by incorporating the metabolic modulating agent into a food or drink, or formulating the metabolic modulating agent into a chewable or swallowable tablet or capsule.
  • Ocular administration may be effected by incorporating the metabolic modulating agent into a solution or suspension adapted for ocular application such as drops or sprays.
  • Subcutaneous administration involves incorporating the metabolic modulating agent into a pharmaceutically acceptable and injectable carrier.
  • the metabolic modulating agent may be conveniently incorporated into a lipophilic carrier and formulated as a topical creme or adhesive patch.
  • the range of dosages and dose rates effective for achieving the desired weight loss, fat loss or modulation of metabolism may be determined in accordance with standard industry practices.
  • Preferred dose and dose rate is sufficient composition to provide about 10 to 500 mg of 7-oxo DHEA per day, administered twice (i.e., 5 to 250 mg 7-oxo DHEA per dose) or thrice (i.e., 3.3 to 167 mg 7-oxo DHEA per dose) daily.
  • RMR Resting metabolic rate
  • Total Body Weight (TB Wgt) was measured with a Tanita TBF-300 digital scale available from Tanita Corporation of Arlington Heights, Illinois.
  • BMI Body Mass Index
  • Each subject sequentially consumed (i) a placebo containing 500 mg of rice powder, (ii) a capsule containing 50 mg of 7- KETOTM and 450 mg of rice powder, or (iii) a capsule containing the formula set forth in Table One, for a treatment period of one week, with each treatment period separated by a one week wash-out period.
  • Each subject was prescribed a specific calorie restricted diet based upon the subject's baseline RMR measurement.
  • the RMR of each subject was determined after a twelve hour fast.
  • Daily total energy expenditure was estimated by multiplying RMR by 1.2.
  • Daily caloric intake for each subject was set at 800 kcal less than the estimated daily total energy expenditure by a dietician.
  • the composition of the diet was 45% of the calories as carbohydrates, 25% of the calories as protein, and 30% of the calories as fat.
  • the subjects were instructed to maintain the calorie restricted diet during each treatment period and return to the subject's normal dietary regimen during each washout period. Subjects were further instructed not to alter their normal activity and exercise routines, refrain from consuming any caffeinated beverages, and refrain from use of any tobacco products for the duration of the study.
  • Subjects had a 0.25% decrease in TBWgt % during Fo ⁇ nula treatment and a 0.37 % gain in TBWgt % during 7-KETOTM treatment. Subjects had only a 0.08 % decrease in TBWgt % during placebo treatment. The gain in TBWgt % during 7-KETOTM treatment is likely secondary to the larger decrease in total body fat percentage seen during this period, allowing a relative increase in fat-free mass percentage and therefore an increase in total body hydration.

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Abstract

A composition containing 7-oxo DHEA, a source of bioavailable chromium, a source of bioavailable calcium, green tea extract and vitamins C & D, and method of promoting weight loss, fat loss or modulation of a dieting-induced change in basal metabolic rate by administration of the composition.

Description

COMPOSITION AN© METHOB OF PROMOTING WEIGHT LOSS9 FAT LOSS OR MODULATION OF METABOLIC RATE
FIELD OF INVENTION
[0001] The invention relates to dietary supplements and dietary supplements effective for promoting weight loss, fat loss or modulation of the basal metabolic rate of a dieting mammal.
BACKGROUND
Weight Loss
[0002] A substantial number of humans, including children and adults, are overweight, obese or at risk of becoming overweight or obese. Significant health risks have been associated with overweight and obesity, including cancer, depression, diabetes, heart disease and hypertension.
[0003] A vast number of products and programs have been developed to assist overweight and obese humans in achieving and sustaining weight loss. However, the vast majority of these products and programs have produced limited success due primarily to an underlying inability of the product or program to promote weight loss and/or an inability of the participant to continue with the product or program due to the significant lifestyle change required to achieve and sustain weight loss with the product or program.
[0004] Accordingly, a need exists for a product and/or program capable of effectively promoting weight loss without requiring a significant lifestyle change.
Fat Loss
[0005] Excessive body fat is a widespread problem. Excessive body fat can be unappealing, often resulting in reduced self-esteem, and can negatively impact an individual's interest and enjoyment of various physical activities. [§006] A vast number of products and programs have been developed to assist persons in achieving fat loss - with or without concomitant weight loss. However, as with such products and programs directed to weight loss, the vast majority of these products and programs have produced limited success due primarily to an underlying inability of the product or program to promote fat loss and/or an inability of the participant to continue with the product or program due to the significant lifestyle change required to achieve and sustain fat loss with the product or program.
[0007] Accordingly, a need exists for a product and/or program capable of effectively promoting fat loss - with or without concomitant weight loss -without requiring a significant lifestyle change.
Basal Metabolic Rate
[0008] Mammals, particularly humans, are believed to have a basal metabolic rate (BMR) which defines the rate at which they convert calories to energy. It is widely believed that BMR is influenced by dieting, with the body reacting to a reduced caloric intake by slowing down the BMR of the dieter. This diet induced reduction in BMR is one of the reasons thought to be responsible for the ineffectiveness of achieving weight loss by dieting.
[0009] Accordingly, a need exists for a method of safely modulating the BMR of a dieting mammal.
7-oxo DHEA
[0010] The steroid Δ5-androstene-3-ol-7, 17-dione (7-oxo DHEA) is believed to stimulate various beneficial biological responses including (i) inducing the synthesis of various thermogenic enzymes which are effective for regulating metabolism and thereby promoting weight control without affecting caloric intake, and (ii) inducing the synthesis of the major thyroid hormone triiodothyronine (T3) which is effective for increasing the basal metabolic rate and thereby promoting weight control without affecting caloric intake. [0011] The ability of 7-oxo DHEA to promote weight control is widely believed to be mediated through enhanced thermogenesis (conversion of foodstuffs to heat energy rather than chemical energy such as ATP and/or triacylglycerides). The thermogenic effect mediated by 7-oxo DHEA is believed to result from the ability of 7-oxo DHEA to stimulate the synthesis of thermogenic enzymes including mitochondrial glycerol 3-phosphate dehydrogenase (G3P-DH), cytosolic malic enzyme (ME) and fatty acyl CoA oxidase. Such enzymes tend to reduce the efficiency of energy metabolism within the body.
[0012] While 7-oxo can be highly effective for safely promoting weight control, a continuing need exists for achieving accelerated weight loss.
Source of Bioavailable Chromium
[0013] Chromium is an essential trace mineral for the human body. It is important in processing carbohydrates and fats, and it helps cells respond properly to insulin. Based upon these biological effects of chromium, it has been suggested that chromium may be effective for promoting weight loss and/or improving lean body mass.
[0014] While chromium may be effective for promoting weight maintenance, weight loss and/or fat loss, a continuing need exists for achieving accelerated weight loss and accelerated fat loss.
Source of Bioavailable Calcium
[0015] Calcium is an essential mineral which builds and strengthens bones and teeth, maintains normal heart beat and regulates blood pressure. Calcium is also essential for the healthy functioning of the nerve system.
[0016] Recent studies suggest that calcium may also help control body weight in humans by increasing the amount of fat that the body uses for fuel. Based upon this biological effect of calcium, it has been suggested that calcium may be effective for promoting weight loss and/or improving lean body mass. [0017] While calcium may be effective for promoting weight loss and/or fat loss, a continuing need exists for achieving accelerated weight loss and accelerated fat loss.
Green Tea Extract
[0018] Green tea is the natural dried leaves of the tea plant, Camelia sinensis. Black tea is oxidized green tea. Green tea, unlike black tea, is not fermented and therefore contains the original active constituents of the leaves. Green tea is rich in bioflavonoids, compounds that help fight damaging free radicals, including polyphenols such as Epigallocatechin Gallate (EGCG). Green tea extract is an amazingly powerful antioxidant, which makes it a benefit to both immune and circulatory health. It is also generally believed that green tea extract may support weight loss and fat loss by increasing energy expenditure.
[0019] While green tea extract may be effective for promoting weight loss or fat loss, a continuing need exists for achieving accelerated weight loss and/or accelerated fat loss.
Vitamin C
[0020] It is believed that vitamin C, also known as ascorbic acid, promotes the absorption of chromium. By virtue of its ability to promote the absorption of chromium, vitamin C can promote weight loss and/or improve lean body mass as chromium- once absorbed - can promote weight loss and/or improve lean body mass.
[0021] While vitamin C may be effective for promoting weight loss and/or improve lean body mass, a continuing need exists for achieving accelerated weight loss and/or accelerated fat loss.
Vitamin D Group
[0022] The vitamin D group, including vitamin D, vitamin D2 and vitamin D3,also known as cholecalciferol, promotes the absorption of calcium. By virtue of its ability to promote the absorption of calcium, the vitamin D group can promote fat loss as calcium - once absorbed - can increase the amount of fat that the body uses for fuel.
[0023] While the vitamin D group may be effective for promoting weight loss and/or fat loss by promoting the absorption of calcium, a continuing need exists for achieving accelerated weight loss and accelerated fat loss.
SUMMARY OF THE INVENTION
[0024] Weight loss, fat loss and modulation of the BMR of a dieting mammal may be achieved by administering a composition including at least (i) 7-oxo DHEA or a pro-drug thereof incapable of in vivo conversion to testosterone, (ii) a source of bioavailable chromium, (iii) a source of bioavailable calcium, (iv) Green Tea extract, (v) vitamin C, and (vi) at least one vitamin from the vitamin D group.
DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT
Definitions
[0025] As utilized herein, including the claims, the term "bioavailable" means capable of being absorbed or becoming available at the site of physiological activity after administration.
[0026] As utilized herein, including the claims, the term "elemental calcium" means calcium (Ca) alone, without regard or reference to any other element or chemical moiety to which the calcium may be bonded or attached.
[0027] As utilized herein, including the claims, the term "elemental chromium" means chromium (Cr) alone, without regard or reference to any other element or chemical moiety to which the chromium may be bonded or attached.
[0028] As utilized herein, including the claims, the term "dieting" means eating and drinking sparingly with the intent to lose weight. [§029] As utilized herein, including the claims, the term " 7-oxo BHEA " means Δ5- androstene-3-ol-7, 17-dione.
[0030] As utilized herein, including the claims, the term "3-acetyl 7-oxo DHEA" means Δ5-androstene-3-acetoxy-7, 17-dione.
<n
Weight Loss and Fat Loss
[0031] I have surprisingly discovered that a composition including at least (i) 7-oxo DHEA or a pro-drug thereof incapable of in vivo conversion to testosterone, and (ii) a source of bioavailable calcium is synergistically effective for promoting weight loss and fat loss, particularly when combined with dieting.
Basal Metabolic Rate
[0032] It is widely believed that dieting is an ineffective means for achieving weight loss because the body reacts to the reduced caloric intake by slowing down the metabolism of the dieter. I have surprisingly discovered that a composition including at least 7-oxo DHEA and a source of bioavailable calcium is synergistically effective for modulating the metabolism of a dieting mammal so as to prevent or at least moderate any diet-induced decrease in metabolism. Such moderation of the metabolism should be effective for accelerating the weight loss achievable by dieting.
The Composition
[0033] The composition includes at least (i) 7-oxo DHEA or a pro-drug thereof incapable of in vivo conversion to testosterone, (ii) a source of bioavailable chromium, (iii) a source of bioavailable calcium, (iv) Green Tea extract, (v) vitamin C, and (vi) at least one vitamin from the vitamin D group. [0034] The composition should include about 0.1 to 80 wt%, preferably about 5 to 10 wt% 7-oxo DHEA or a pro-drug thereof incapable of in vivo conversion to testosterone, a trace amount (typically 50 to 250 μg per daily dose) elemental chromium, about 1 to 90 wt%, preferably 20 to 40 wt% elemental calcium, about 0.1 to 80 wt%, preferably 20 to 40 wt% Green Tea extract, 0.1 to 90 wt%, preferably 20 to 40 wt% vitamin C and a trace amount (typically 10 to 50 μg per daily dose) vitamin D3. Selection of the most advantageous ratio of these ingredient to achieve the desired biological effect (e.g., weight loss, prevention of weight gain, fat loss, prevention of fat gain, etc.) for a defined group (e.g., males, females, young adults, senior citizens, etc.) at a given dose and dose rate (e.g., once daily, with each meal) can be established in accordance with standard industry practices.
7-oxo DHEA
[0035] 7-oxo DHEA is a derivative of dehydroepiandrosterone (DHEA). 7-oxo DHEA does not appreciably stimulate, increase or otherwise enhance the production of sex hormones. The steroid is commercially available from a number of sources including Steraloids, Inc. of Wilton, New Hampshire. A number of procedures are available for synthesizing Δ5-androstene-3β-ol-7,17 dione from DHEA, with one such procedure described in United States Patent No. 5,296,481.
[0036] Pro-drugs of 7-oxo DHEA {i.e., compounds readily metabolized in vivo to the active 7-oxo DHEA) may also be usefully employed. One example of a 7-oxo DHEA pro¬ drug is the commercially available Δ5-androstene-3β-acetyl-7,17 dione (3-acetyl 7-oxo DHEA). The 3β-acetyl group is hydrolyzed in vivo by esterases located in the blood and various tissue to produce the active 7-oxo DHEA, and is believed to be less susceptible to oxidation during the manufacturing process relative to 7-oxo DHEA. Other suitable pro¬ drugs include Δ5-androstene-3β, 17β-diol-7-one, Δ5-androstene-3β, 7α-diol-17-one, Δ5- androstene-3β, 7β-diol-17-one and the corresponding esters, ethers and carbonates of these steroids. Chromium
[0037] A variety of compounds containing bioavailable chromium are known and commercially available including chromium picolinate, chromium chloride, chromium nicotinate, and high-chromium yeast. By way of example, chromium picolinate is commercially available from Nutrition 21 of Purchase, New York.
Calcium
[0038] Calcium is found in milk and other dairy products such as cheese and yogurt. Calcium is also found in dark green vegetables and dried beans. A variety of compounds containing bioavailable calcium are known and commercially available, including calcium citrate, calcium carbonate, calcium gluconate, calcium lactate, dolomite, bone meal, oyster shell, and coral calcium. By way of example, calcium carbonate is commercially available the J.M. Huber Corporation of Edison, New Jersey.
Green Tea Extract
[0039] The production of Green Tea extract is well known in the art. For example, green tea leaves are typically extracted with hot or cold water to form a solution containing tea catechins and caffeine. This green tea solution may be further concentrated to form either a concentrated extract solution or a dry powder. The extract solution or the powder may contain stabilizers, such as food-approved acids, e.g. citric acid, ascorbic acid, isoascorbic acid, and the like.
[0040] Green tea extract powders are commercially available from a number of sources, including Guizhou Highyin Biological Product Co., Guiyang, P.R. China, or Zhejang Zhongke Plant Technical Co. Ltd., Hangzhou, Zhejang, P.R. China. A preferred green tea extract is one containing a high concentration of epigallocatechin gallate (EGCG) and a minimal concentration of caffeine or is a caffeine-free extract. Vitamins C & D
[0041] Vitamins C and the vitamins in the vitamin D group (i.e., vitamins D, D2 and D3) are well known essential nutrients widely available from a number of sources.
Administration
Administration Route
[0042] The composition can be administered by virtually any of the commonly accepted practices for the administration of pharmaceutical preparations including specifically, but not exclusively, mucosal administration, oral consumption, ocular administration, subcutaneous injection, transdermal administration, etc. Oral administration is generally preferred.
[0043] Mucosal administration of the metabolic modulating agent includes such routes as buccal, endotracheal, nasal, pharyngeal, rectal, sublingual, vaginal, etc. For administration through the buccal/sublingual/pharyngeal/endotracheal mucosal, the metabolic modulating agent may be formulated as an emulsion, gum, lozenge, spray, tablet or an inclusion complex such as cyclodextrin inclusion complexes. Nasal administration is conveniently conducted through the use of a sniffing powder or nasal spray. For rectal and vaginal administration the metabolic modulating agent may be formulated as a cream, douche, enema or suppository.
[0044] Oral consumption of the metabolic modulating agent may be effected by incorporating the metabolic modulating agent into a food or drink, or formulating the metabolic modulating agent into a chewable or swallowable tablet or capsule.
[0045] Ocular administration may be effected by incorporating the metabolic modulating agent into a solution or suspension adapted for ocular application such as drops or sprays. [0046] Subcutaneous administration involves incorporating the metabolic modulating agent into a pharmaceutically acceptable and injectable carrier.
[0047] For transdermal administration, the metabolic modulating agent may be conveniently incorporated into a lipophilic carrier and formulated as a topical creme or adhesive patch.
Dosage and Dose Rate
[0048] The range of dosages and dose rates effective for achieving the desired weight loss, fat loss or modulation of metabolism may be determined in accordance with standard industry practices. Preferred dose and dose rate is sufficient composition to provide about 10 to 500 mg of 7-oxo DHEA per day, administered twice (i.e., 5 to 250 mg 7-oxo DHEA per dose) or thrice (i.e., 3.3 to 167 mg 7-oxo DHEA per dose) daily.
EXPERIMENTAL
Glossary
7-KETO™ 3 -acetyl 7-oxo DHEA purchased from Humanetics
Corporation.
BMI Body Mass Index
RMR Resting Metabolic Rate p Value Matched Pair t-test
Calibration and Measurement Techniques
Restinε Metabolic Rate
[0049] Resting metabolic rate (RMR) was measured by indirect calorimetry using a Deltatrac II™ Metabolic Monitor available from Sensor Medics Corp of Yorba Linda, California. Subjects were asked to fast (except for water) for 12 hours prior the RMR measurements and not to change their current activity levels. Subjects were allowed to rest for 15 minutes prior to RMR measurement and then positioned recumbent and alone in a quiet, dimly lit and temperature controlled room. Each subject underwent a total of 25 minutes of respiratory sampling under the hood with an energy expenditure reading obtained at one-minute intervals. The final 20 minutes of readings were averaged to obtain the RMR.
Total Body Weight
[0050] Total Body Weight (TB Wgt) was measured with a Tanita TBF-300 digital scale available from Tanita Corporation of Arlington Heights, Illinois.
Body Mass Index
[0051] Body Mass Index (BMI) was measured with a Quantum II™ Bioelectric Impedance Analysis Instrument equipped with Cyprus™ 1.2 analysis software available from RJL Systems of Clinton Township, Michigan.
Subjects
[0052] Healthy adults aged 23 to 47 years with a BMI > 26 and < 40 kg/m2 were eligible for the study. Individuals with hepatic or renal disease, diabetes, unstable cardiovascular disease, uncontrolled hypertension, eating disorder (diagnosed anorexia or bulimia), active cancer, human immunodeficiency virus infection, AIDS or surgery for weight loss were excluded from the study. Subjects were also excluded if they were using medications for weight loss or were pregnant or lactating. [0053] This was a prospective, randomized, double blind, crossover trial with intervening washout period and baseline measurement. Each subject sequentially consumed (i) a placebo containing 500 mg of rice powder, (ii) a capsule containing 50 mg of 7- KETO™ and 450 mg of rice powder, or (iii) a capsule containing the formula set forth in Table One, for a treatment period of one week, with each treatment period separated by a one week wash-out period. Subjects were randomized equally to each order of the three treatment periods (Placebo / 7-KETO™ / Formula) (Placebo / Formula / 7-KETO™) (7- KETO™ / Formula / Placebo) (7-KETO™ / Placebo / Formula) (Formula / Placebo / 7- KETO™) (Formula / 7-KETO™ / Placebo).
TABLE ONE Composition of Formula
Figure imgf000013_0001
* standardized for 50% epigallocatechin gallate.
[0054] Immediately prior to each treatment period, a baseline value of RMR, BMI, TBWgt, % Body Fat, and Total Caloric Intake (TCI) were measured for each subject. These measurements were taken again at the end of each treatment period for each subject.
[0055] Each subject was prescribed a specific calorie restricted diet based upon the subject's baseline RMR measurement. The RMR of each subject was determined after a twelve hour fast. Daily total energy expenditure was estimated by multiplying RMR by 1.2. Daily caloric intake for each subject was set at 800 kcal less than the estimated daily total energy expenditure by a dietician. The composition of the diet was 45% of the calories as carbohydrates, 25% of the calories as protein, and 30% of the calories as fat. The subjects were instructed to maintain the calorie restricted diet during each treatment period and return to the subject's normal dietary regimen during each washout period. Subjects were further instructed not to alter their normal activity and exercise routines, refrain from consuming any caffeinated beverages, and refrain from use of any tobacco products for the duration of the study.
Study
[0056] Forty five eligible subjects (34 women and 11 men) with a mean age of 38.6 years ranging from 23 to 47 years, enrolled in the study. Forty enrolled subjects (30 women and 10 men) completed the study. The mean baseline value of RMR, BMI, TBWgt, % Body Fat, and Total Caloric Intake (TCI) prior to each treatment period, the mean change in BMI, TBWgt, % Body Fat, and Total Caloric Intake (TCI) from the baseline value after each treatment period, the mean and percentage changes in RMR, and the matched treatment-pair analysis of mean change in RMR are set forth in Tables Two, Three, Four and Five below respectively.
TABLE TWO Baseline Values
Figure imgf000014_0001
TABLE THREE
Mean Changes from Baseline Values
Figure imgf000015_0001
TABLE FOUR
Mean and % Changes in RMR
Figure imgf000015_0002
TABLE FIVE Matched Treatment-Pair Analysis of Mean Change in RMR
Figure imgf000015_0003
Results
RMR
[0057] There was a mean decrease in RMR of 75 ± 111 kcal/day (3.9%) in the placebo treatment (restricted calorie diet alone), a mean increase in RMR of 21 ± 115 kcal/day (1.4%) in the 7-KETO™ treatment, and a mean increase in RMR of 59 ± 118 kcal/day (3.4%) in the Formula treatment. When compared to the placebo treatment, the Formula treatment had a 7.29 % increase in RMR above that seen with restricted calorie diet alone and the 7-KETO™ treatment had a 5.36 % increase in RMR above that seen with restricted calorie diet alone. Matched-pair t-tests were used to compare the mean change in RMR in each of the treatment periods. The mean increase in RMR with Formula was significantly (p=0.001) greater when compared to placebo (restricted calorie diet alone) and the means increase in RMR with 7-KETO™ treatment was also significantly (p=0.001) greater that placebo treatment.
[0058] Subjects had a 0.25% decrease in TBWgt % during Foπnula treatment and a 0.37 % gain in TBWgt % during 7-KETO™ treatment. Subjects had only a 0.08 % decrease in TBWgt % during placebo treatment. The gain in TBWgt % during 7-KETO™ treatment is likely secondary to the larger decrease in total body fat percentage seen during this period, allowing a relative increase in fat-free mass percentage and therefore an increase in total body hydration.

Claims

CLAIMS OF THE INVENTIONI Claim:
1. A composition comprising (i) 7-oxo DHEA or a pro-drug thereof incapable of in vivo conversion to testosterone, (ii) a source of bioavailable chromium, (iii) a source of bioavailable calcium, (iv) Green Tea extract, (v) vitamin C, and (vi) at least one vitamin from the vitamin D group.
2. The composition of claim 1 wherein the composition contains at least (i) 10 to 500 mg 7-oxo DHEA or a pro-drug thereof incapable of in vivo conversion to testosterone, (ii) 10 to 1,000 μg of elemental chromium, (iii) 100 to 5,000 mg of elemental calcium, (iv) 10 to 2,000 mg Green Tea extract, (v) 10 to 5,000 mg vitamin C, and (vi) 1 to 100 μg vitamin D3.
3. The composition of claim 1 wherein 7-oxo DHEA or a pro-drug thereof incapable of in vivo conversion to testosterone is 3 -acetyl 7-oxo DHEA or a 3 -ester thereof.
4. The composition of claim 1 wherein the source of bioavailable chromium is chromium picolinate or chromium nicotinate.
5. The composition of claim 1 wherein the source of bioavailable calcium is calcium citrate or calcium carbonate.
6. The composition of claim 1 wherein the composition includes 7-oxo DHEA or a pro-drug thereof incapable of in vivo conversion to testosterone, a source of bioavailable chromium, a source of bioavailable calcium, Green Tea extract, vitamin C, and at least one vitamin from the vitamin D group in amounts effective for synergistically modulating the metabolism of a dieting mammal.
7. The composition of claim 1 wherein the composition includes 7-oxo DHEA or a pro-drug thereof incapable of in vivo conversion to testosterone, a source of bioavailable chromium, a source of bioavailable calcium, Green Tea extract, vitamin C, and at least one vitamin from the vitamin D group in amounts effective for synergistically promoting weight loss.
8. The composition of claim 1 wherein the composition includes 7-oxo DHEA or a pro-drug thereof incapable of in vivo conversion to testosterone, a source of bioavailable chromium, a source of bioavailable calcium, Green Tea extract, vitamin C, and at least one vitamin from the vitamin D group in amounts effective for synergistically promoting fat loss.
9. A method of promoting weight loss comprising administration of a composition to a mammal in need of achieving weight loss wherein the composition includes at least the ingredients (i) 7-oxo DHEA or a pro-drug thereof incapable of in vivo conversion to testosterone, (ii) a source of bioavailable chromium, (iii) a source of bioavailable calcium, (iv) Green Tea extract, (v) vitamin C, and (vi) at least one vitamin from the vitamin D group.
10. A method of achieving accelerated weight loss comprising administration of a composition to a dieting mammal wherein the composition includes at least the ingredients (i) 7-oxo DHEA or a pro-drug thereof incapable of in vivo conversion to testosterone, (ii) a source of bioavailable chromium, (iii) a source of bioavailable calcium, (iv) Green Tea extract, (v) vitamin C, and (vi) at least one vitamin from the vitamin D group.
11. The composition of claims 9 or 10 wherein the composition contains at least (i) 10 to 500 mg 7-oxo DHEA or a pro-drug thereof incapable of in vivo conversion to testosterone, (ii) 10 to 1,000 μg of elemental chromium, (iii) 100 to 5,000 mg of elemental calcium, (iv) 10 to 2,000 mg Green Tea extract, (v) 10 to 5,000 mg vitamin C, and (vi) 1 to 100 μg vitamin D3..
12. The method of claims 9 or 10 wherein the composition is administered orally.
13. The method of claim 9 or 10 wherein the composition is administered at least once daily.
14. The method of claims 9 or 10 wherein the mammal is a human.
15. The method of claims 9, 10, 11, 12 or 14 wherein the ingredient 7-oxo DHEA or a pro-drug thereof incapable of in vivo conversion to testosterone is 3-acetyl 7-oxo DHEA or 3-ester thereof.
16. The composition of claim 11 wherein the source of bioavailable chromium is chromium picolinate or chromium nicotinate.
17. The composition of claim 11 wherein the source of bioavailable calcium is calcium citrate or calcium carbonate.
18. A method of promoting fat loss comprising administration of a composition to a mammal in need of achieving fat loss wherein the composition includes at least the ingredients (i) 7-oxo DHEA or a pro-drug thereof incapable of in vivo conversion to testosterone, (ii) a source of bioavailable chromium, (iii) a source of bioavailable calcium, (iv) Green Tea extract, (v) vitamin C, and (vi) at least one vitamin from the vitamin D group.
19. A method of achieving accelerated fat loss comprising administration of a composition to a dieting mammal wherein the composition includes at least the ingredients (i) 7-oxo DHEA or a pro-drug thereof incapable of in vivo conversion to testosterone, (ii) a source of bioavailable chromium, (iii) a source of bioavailable calcium, (iv) Green Tea extract, (v) vitamin C, and (vi) at least one vitamin from the vitamin D group.
20. The composition of claims 18 or 19 wherein the composition contains at least (i) 10 to 500 mg 7-oxo DHEA or a pro-drug thereof incapable of in vivo conversion to testosterone, (ii) 10 to 1,000 μg of elemental chromium, (iii) 100 to 5,000 mg of elemental calcium, (iv) 10 to 2,000 mg Green Tea extract, (v) 10 to 5,000 mg vitamin C, and (vi) 1 to 100 μg vitamin D3.
21. The method of claims 18 or 19 wherein the composition is administered orally.
22. The method of claim 21 wherein the composition is administered at least once daily.
23. The method of claims 18, 19, 20 or 22 wherein the mammal is a human.
24. The method of claim 23 wherein the ingredient 7-oxo DHEA or a pro-drug thereof incapable of in vivo conversion to testosterone is 3 -acetyl 7-oxo DHEA or 3 -ester thereof.
25. The composition of claim 20 wherein the source of bioavailable chromium is chromium picolinate or chromium nicotinate.
26. The composition of claim 20 wherein the source of bioavailable calcium is calcium citrate or calcium carbonate.
27. A method of modulating the metabolism of a dieting mammal comprising administration of a composition to the dieting mammal wherein the composition includes at least the ingredients (i) 7-oxo DHEA or a pro-drug thereof incapable of in vivo conversion to testosterone, (ii) a source of bioavailable chromium, (iii) a source of bioavailable calcium, (iv) Green Tea extract, (v) vitamin C, and (vi) at least one vitamin from the vitamin D group.
28. The composition of claim 27 wherein the composition contains at least (i) 10 to 500 mg 7-oxo DHEA or a pro-drug thereof incapable of in vivo conversion to testosterone, (ii) 10 to 1,000 μg of elemental chromium, (iii) 100 to 5,000 mg of elemental calcium, (iv) 10 to 2,000 mg Green Tea extract, (v) 10 to 5,000 mg vitamin C, and (vi) 1 to 100 μg vitamin D3.
29. The method of claim 27 wherein the composition is administered orally.
30. The method of claim 27 wherein the composition is administered at least once daily.
J l. 1 ήe method ot claims 2 /. 28 or 29 wherein the mammal is a human.
32. The method of claim 31 wherein the ingredient 7-oxo DHEA or a pro-drug thereof incapable of in vivo conversion to testosterone is 3 -acetyl 7-oxo DHEA or 3 -ester thereof.
33. The composition of claim 28 wherein the source of bioavailable chromium is chromium picolinate or chromium nicotinate.
34. The composition of claim 28 wherein the source of bioavailable calcium is calcium citrate or calcium carbonate.
PCT/US2005/027518 2004-08-06 2005-08-02 Composition and method of promoting weight loss, fat loss or modulation of metabolic rate WO2006017551A1 (en)

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GB2453797B (en) * 2005-03-23 2010-03-31 Edward Larry Mccleary Composition and method for modulating hydrogen ion physiology
US8202512B2 (en) 2000-12-28 2012-06-19 Mccleary Edward Larry Metabolic uncoupling therapy

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Publication number Priority date Publication date Assignee Title
US8202512B2 (en) 2000-12-28 2012-06-19 Mccleary Edward Larry Metabolic uncoupling therapy
US8703209B2 (en) 2003-06-17 2014-04-22 Edward Larry McCleary Composition and method for modulating hydrogen ion physiology
GB2453797B (en) * 2005-03-23 2010-03-31 Edward Larry Mccleary Composition and method for modulating hydrogen ion physiology

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