US 7,329,419 B2
(12) United States Patent
Yatcilla et al.
(54) HERBAL SUPPLEMENT TO SUPPORT
WEIGHT LOSS
(10) Patent No.: US 7,329,419 B2
(45) Date of Patent: Feb. 12, 2008
(75) Inventors: Michael Yatcilla, Los Angeles, CA
(US); Kim Krumhar, Carlsbad, CA
(US); Janice Thompson, Rancho
Santa Fe, CA (US)
(73) Assignee: Herbalife International, Inc., Los
Angeles, CA (US)
(*) Notice: Subject to any disclaimer, the term
of this patent is extended or adjusted
under 35 U.S.C. 154(b) by 0 days.
(21) Appl. No.: 11/233,782
(22) Filed: Sep. 22, 2005
(65)Prior Publication Data
US 2006/0165820 A1Jul. 27, 2006
Related U.S. Application Data
(60) Provisional application No. 60/612,426, filed on
Sep. 23, 2004.
(51) Int. Cl.
A61K 36/00(2006.01)
(52) U.S. Cl. ……………………………….424/725
(58) Field of Classification Search ………….. None
See application file for complete search history.
(56) References Cited
U.S. PATENT DOCUMENTS
2001/0008641 A1* 7/2001 Krotzer ………424/725
2002/0164387 A1 11/2002 Wei et. Al.
2004/0077556 A1 4/2004 Chinery
2005/0085454 A1* 4/2005 Ghosal……….514/185
OTHER PUBLICATIONS
Anonymous. “Xenadrine EFX; Product Profile (More Info).” Internet Article, ‘Online!’ Aug. 6, 2004. URL: http://web.archive.org/web/20040806054855/http://www.cytodynecom/products. html>Retrieved on Jan. 26, 2006.
Anonymous. “Xenadrine NRG; Product Profile (More Info)” Internet Article, ‘Online!’ Aug. 6, 2004. URL: http://web.archive.org/web/20040806054855/http://www.cytodynecom/products. html>Retrieved on Jan. 26, 2006.
Nasir et al. “Exercise-induced syncope associated with QT prolongation and ephedra-free Xenadrine.” May Clinic Proceedings 2004. 79(8):1059-1062 (2004).
Saldana et al. “Extraction of Purine Alkaloids from Mate (llex paraguariensis) Using Supercritical CO2.” Journal of Agricultural and Food Chemistry. 47(9):3804-3808 (1999).
*cited by examiner
Primary Examiner – Christopher R. Tate
Assistant Examiner – Deborah A. Davis
(74) Attorney, Agent, or Firm – Knobbe, Martens, Olson & Bear LLP
(57)ABSTRACT
Disclosed herein are herbal and chemical combinations for promoting weight loss. The herbs in the composition can include, among others, green tea, ginger, coca, and yerba mate. Other chemicals in the composition can include, among others, caffeine and a pharmaceutically acceptable salt of calcium.
21 Claims, No Drawings
1
HERBAL SUPPLEMENT TO SUPPORT
WEIGHT LOSS
RELATED APPLICATIONS
This application is a non-provisional application, and claims priority to the U.S. Provisional Patent Application Ser. No. 60/612,426, filed on Sep. 23, 2004, by Yatcilla et al., and entitled “HERBAL SUPPLEMENT TO SUPPORT WEIGHT LOSS,” the disclosure of which is incorporated by reference herein in its entirety, including any drawings.
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to pharmaceuticals and herbal supplements. More particularly, the present invention relates to combinations of herbal and other chemical ingredients useful in effecting weight loss.
2. Description of the Related Art
Obesity and an increasingly overweight population are a continuing problem among the American public. To combat this problem, many diets, exercise programs, pharmaceuticals, and herbal supplements have been developed. In the past, one series of herbal supplements in common use contained the drug ephedra. Such supplements were promoted as aiding weight loss, enhancing sports performance, and increasing energy. Due in part to perceived adverse side effects, the FDA has recommended that the public stop using the ephedra-containing supplements. Thus, there is a heightened need for alternative herbal supplements that may promote weight loss and increase energy without the adverse effects now associated with ephedra-containing supplements.
SUMMARY OF THE INVENTION
One aspect of the present invention is a tablet comprising green tea, ginger, caffeine, cocoa, and yerba mate.
One aspect of the present invention is a tablet comprising green tea, ginger, caffeine, cocoa, yerba mate, and calcium.
Another aspect of the present invention is a tablet comprising epigallocatechin-3-gallate, caffeine, theobromine, gingerols, and yerba mate.
Another aspect of the present invention is a tablet comprising green tea, ginger, caffeine, cocoa, and yerba mate wherein between 25% and 75% of active ingredients are green tea, between 10% and 30% of active ingredients are ginger, between 5% and 25% of active ingredients are caffeine, between 2% and 20% of active ingredients are cocoa, and between 2% and 20% of active ingredients are yerba mate.
Another aspect of the present invention is a tablet comprising green tea, ginger, caffeine, cocoa, yerba mate, and calcium wherein between 20% and 45% of active ingredients are green tea extract, between 5% and 20% of active ingredients are cocoa extract, between 5% and 20% of active ingredients are yerba mate extract, between 5% and 25% of active ingredients are caffeine, and between 5% and 20% of active ingredients are calcium.
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Another aspect of the present invention is a tablet comprising green tea, ginger, caffeine, cocoa, calcium, yerba mate, hawthorne berry, parsley leaf, marshmallow root, fennel seed, astragalus root, licorice root, suma, cinnamon, celery seed, and alfalfa leaf, wherein between 10% and 40% of active ingredients are green tea, between 5% and 25% of active ingredients are ginger, between 1% and 20% of active ingredients are caffeine, between 1% and 20% of active ingredients are cocoa, between 10% and 30% of active ingredients are calcium, between 1% and 20% of active ingredients are yerba mate, between 0.1% and 5% of active ingredients are hawthorne berry, between 0.1% and 5% of active ingredients are parsley leaf, between 0.1% and 5% of active ingredients are marshmallow root, between 0.1% and 5% of active ingredients are fennel seed, between 0.1% and 5% of active ingredients are astragalus root, between 0.1% and 5% of active ingredients are licorice root, between 0.1% and 5% of active ingredients are suma, between 0.1% and 5% of active ingredients are cinnamon, between 0.1% and 5% of active ingredients are celery seed, and between 0.1% and 5% of active ingredients are alfalfa leaf.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
In some embodiments, compositions are provided that include non-ephedra-containing herbal components or extracts and/or other chemical compounds. In some embodiments, these compositions promote weight loss when administered to a mammal, such as a human. In some embodiments, these compositions increase energy when administered to a mammal, such as a human. In some embodiments, these compositions increase the metabolic rate of a mammal, such as a human when administered to the mammal. In some embodiments, these compositions increase thermogenesis when administered to a mammal, such as a human. In some embodiments, these compositions decrease cravings for food when administered to a mammal, such as a human. In some embodiments, these compositions are particularly useful for males. In some embodiments, these compositions are particularly useful for females.
In other embodiments, methods are provided for promoting weight loss, increasing energy, increasing metabolic rate, increasing thermogenesis, and/or decreasing cravings for food by administering the compositions disclosed herein.
Active Ingredients – Herbal Sources
In some embodiments, green tea may be included in the compositions disclosed herein. In one embodiment, the green tea is included as Tier 1 Green Tea Extract, which contains 50% epigallocetachin-3-gallate (EGCG). EGCG increases metabolism by approximately 5% compared to control. EGCG lowers the respiratory quotient, thereby increasing the metabolic oxidation of fat. Catechins, such as those found in green tea, have also been associated with decreased rates of certain cancers. The green tea extract may comprise from between 3% and 80% of the total active ingredients. In some embodiments, the gree tea extract is
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between 10% and 50% of the total active ingredients. In some embodiments, the green tea extract is between 20% and 40% of the total active ingredients. In some embodiments, the green tea extract is between 25% and 30% of the total active ingredients.
In some embodiments, ginger may be included in the compositions disclosed herein. In some embodiments, the ginger is included as ginger extract that contains between 1% and 20% gingerol content. In one embodiment, the ginger extract contains 6% gingerols. Gingerols are a carminative that calms the stomach and have been shown in animal studies to increase energy expenditure (metabolic rate) in muscle tissues. The ginger extract may comprise from between 1% and 80% of the total active ingredients. In some embodiments, the ginger extract is between 3% and 60% of the total active ingredients. In some embodiments, the ginger extract is between 5% and 40% of the total active ingredients. In some embodiments, the ginger extract is between 8% and 30% of the total active ingredients. In some embodiments, the ginger extract is between 10% and 20% of the total active ingredients.
In some embodiments, cocoa may be included in the compositions disclosed herein. In one embodiment, the cocoa is an extract from Theobroma cacao seeds. In one embodiment, the extract contains 6% theobromine. Theobromine boosts metabolism without simultaneously stimulating the central nervous sytem. The cocoa extract may comprise from between 1% and 50% of the total active ingredients. In some embodiments, the cocoa extract is between 2% and 40% of the total active ingredients. In some embodiments, the cocoa extract is between 3% and 25% of the total active ingredients. In some embodiments, the cocoa extract is between 4% and 15% of the total active ingredients. In some embodiments, the cocoa extract is between 4% and 10% of the total active ingredients.
In some embodiments, Yerba Mate (Ilex paraguarensis) may be included in the compositions disclosed herein. In one embodiment, the Yerba Mate is included as an extract from Ilex paraguarensis leaves. Yerba Mate contains caffeine and is a stimulant. In some embodiments, the Yerba Mate extract contains 8% caffeine. The Yerba Mate extract may comprise from between 1% and 50% of the total active ingredients. In some embodiments, the Yerba Mate extract is between 2% and 40% of the total active ingredients. In some embodiments, the Yerba Mate extract is between 3% and 25% of the total active ingredients. In some embodiments, the Yerba Mate extract is between 4% and 15% of the total active ingredients. In some embodiments, the Yerba Mate extract is between 4% and 10% of the total active ingredients.
In some embodiments, celery may be included in the compositions disclosed herein. In one embodiment, celery is included as a dried powder of celery seeds. The celery may comprise from between 0.1% and 20% of the total active ingredients. In some embodiments, the celery is between 0.2% and 10% of the total active ingredients. In some embodiments, the celery is between 0.4% and 5% of the total active ingredients. In some embodiments, the celery is between 0.6% and 3% of the total active ingredients. In some embodiments, the celery is between 1% and 2% of the total active ingredients.
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In some embodiments, Hawthorne berry may be included in the compositions disclosed herein. In one embodiment, Hawthorne berry is included as a dried powder. Hawthorn berry powder has antioxidant properties and is known to offer benefits to the health and function of the human heart, helping to reduce the incidence of necrosis of heart tissue and thereby improve cardiac efficiency. The Hawthorne berry may comprise from between 0.1% and 20% of the total active ingredients. In some embodiments, the Hawthorne berry is between 0.2% and 10% of the total active ingredients. In some embodiments, the Hawthorne berry is between 0.4% and 5% of the total active ingredients. In some embodiments, the Hawthorne berry is between 0.6% and 3% of the total active ingredients. In some embodiments, the Hawthorne berry is between 1% and 2% of the total active ingredients.
In some embodiments, parsley may be included in the compositions disclosed herein. In one embodiment, celery is included as a dried powder of parsley leaves. The parsley may comprise from between 0.1% and 20% of the total active ingredients. In some embodiments, the parsley is between 0.2% and 10% of the total active ingredients. In some embodiments, the parsley is between 0.4% and 5% of the total active ingredients. In some embodiments, the parsley is between 0.6% and 3% of the total active ingredients. In some embodiments, the parsley is between 1% and 2% of the total active ingredients.
In some embodiments, marshmallow (Althaea officinalis) may be included in the compositions disclosed herein. In one embodiment, marshmallow is included as a dried powder of marshmallow roots. The marshmallow may comprise from between 0.1% and 20% of the total active ingredients. In some embodiments, the marshmallow is between 0.2% and 10% of the total active ingredients. In some embodiments, the marshmallow is between 0.4% and 5% of the total active ingredients. In some embodiments, the marshmallow is between 0.6% and 3% of the total active ingredients. In some embodiments, the marshmallow is between 1% and 2% of the total active ingredients.
In some embodiments, fennel may be included in the compositions disclosed herein. In one embodiment, fennel is included as a dried powder of fennel seeds. The fennel may comprise from between 0.1% and 20% of the total active ingredients. In some embodiments, the fennel is between 0.2% and 10% of the total active ingredients. In some embodiments, the fennel is between 0.4% and 5% of the total active ingredients. In some embodiments, the fennel is between 0.6% and 3% of the total active ingredients. In some embodiments, the fennel is between 1% and 2% of the total active ingredients.
In some embodiments, astragalus may be included in the compositions disclosed herein. In one embodiment, astragalus is included as a dried powder of astragalus roots. The astragalus may comprise from between 0.1% and 20% of the total active ingredients. In some embodiments, the astragalus is between 0.2% and 10% of the total active ingredients. In some embodiments, the astragalus is between 0.4% and 5% of the total active ingredients. In some embodiments, the astragalus is between 0.6% and 3% of the total active ingredients. In some embodiments, the
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astragalus is between 1% and 2% of the total active ingredients.
In some embodiments, licorice may be included in the compositions disclosed herein. In one embodiment, licorice is included as a dried powder of licorice roots. The licorice may comprise from between 0.1% and 20% of the total active ingredients. In some embodiments, the licorice is between 0.2% and 10% of the total active ingredients. In some embodiments, the licorice is between 0.4% and 5% of the total active ingredients. In some embodiments, the licorice is between 0.6% and 3% of the total active ingredients. In some embodiments, the licorice is between 1% and 2% of the total active ingredients.
In some embodiments, suma (Pfaffia paniculata) may be included in the compositions disclosed herein. In one embodiment, suma is included as a dried powder of suma roots. The suma may comprise from between 0.1% and 20% of the total active ingredients. In some embodiments, the suma is between 0.2% and 10% of the total active ingredients. In some embodiments, the suma is between 0.4% and 5% of the total active ingredients. In some embodiments, the suma is between 0.6% and 3% of the total active ingredients. In some embodiments, the suma is between 1% and 2% of the total active ingredients.
In some embodiments, cinnamon may be included in the compositions disclosed herein. In one embodiment, cinnamon is included as a dried extract of cinnamon bark. The cinnamon may comprise from between 0.1% and 20% of the total active ingredients. In some embodiments, the cinnamon is between 0.2% and 10% of the total active ingredients. In some embodiments, the cinnamon is between 0.3% and 5% of the total active ingredients. In some embodiments, the cinnamon is between 0.4% and 2% of the total active ingredients. In some embodiments, the cinnamon is between 0.5% and 1% of the total active ingredients.
In some embodiments, alfalfa may be included in the compositions disclosed herein. In one embodiment, alfalfa is included as a alfalfa leaves. The alfalfa may comprise from between 0.1% and 20% of the total active ingredients. In some embodiments, the alfalfa is between 0.3% and 10% of the total active ingredients. In some embodiments, the alfalfa is between 0.5% and 5% of the total active ingredients. In some embodiments, the alfalfa is between 0.1% and 2% of the total active ingredients. In some embodiments, the alfalfa is between 0.15% and 0.5% of the total active ingredients.
Active Ingredients – Chemical Compounds
In some embodiments, calcium may be included in the compositions disclosed herein. The calcium may be included as any pharmaceutically acceptable salt of calcium. In one embodiment, calcium is included as calcium carbonate. Calcium is known to lower the absorption of dietary fat by complexing with fatty acids during the digestive process to form insoluble, indigestible soaps that are then eliminated from the body. Certain calcium salts such as calcium carbonate are also useful excipients and aid in tableting. The calcium may comprise from between 1% to 50% of the total active ingredients. In some embodiments, the calcium is between 2% and 40% of
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the total active ingredients. In some embodiments, the calcium is between 3% and 25% of the total active ingredients. In some embodiments, the calcium is between 4% and 15% of the total active ingredients. In some embodiments, the calcium is between 5% and 10% of the total active ingredients.
In some embodiments, caffeine may be included in the compositions disclosed herein. In one embodiment, caffeine is included as anhydrous powder. Caffeine acts on the central nervous system to increase alertness, muscular activity, and fatty acid released for metabolism and production of cellular energy. The caffeine may comprise from between 1% and 50% of the total active ingredients. In some embodiments, the caffeine is between 2% and 40% of the total active ingredients. In some embodiments, the caffeine is between 3% and 25% of the total active ingredients. In some embodiments, the caffeine is between 4% and 20% of the total active ingredients. In some embodiments, the caffeine is between 5% and 15% of the total active ingredients.
Combinations of Active Ingredients
In some embodiments, compositions are provided that comprise mixtures of some or all of the active ingredients described above. In some embodiments, compositions are provided that comprise green teat extract, ginger extract, and caffeine. In some embodiments, the foregoing composition comprises between 20% and 65% of the total active ingredients of green tea extract, between 10% and 40% of the total active ingredients as ginger extract, and between 5% and 35% of the total active ingredients as caffeine. In some embodiments, the ingredients of this composition work together synergistically to increase overall metabolic rate and oxidation of fat for energy in cells. In some embodiments, this composition provides a 5% daily increase in metabolic energy expenditure (e.g., between 80-100 Kcals per day).
In some embodiments, compositions are provided that comprise green tea, ginger, cocoa, and yerba mate. In some embodiments, the foregoing composition comprises between 20% and 45% of the total active ingredients as green tea extract, between 10% and 30% of the total active ingredients as cocoa extract, and between 5% and 20% of the total active ingredients as yerba mate extract.
In some embodiments, compositions are provided that comprise green tea, ginger, caffeine, cocoa, and yerba mate. In some embodiments, the foregoing composition comprises between 25% and 75% of active ingredients as green tea, between 10% and 30% of the total active ingredients as ginger, between 5% and 25% of active ingredients as caffeine, between 2% and 20% of active ingredients as cocoa, and between 2% and 20% of active ingredients as yerba mate.
In some embodiments, pharmaceutical compositions are provided that comprise a mixture of epigallocatechin-3-gallate, caffeine, and gingerols. In some embodiments, pharmaceutical compositions are provided that comprise a mixture of epigallocatechin-3-gallate, theobromine, gingerols, and caffeine. In some embodiments, pharmaceutical compositions are provided that comprise a
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mixture of epigallocatechin-3-gallate, theobromine, gingerols, caffeine, and calcium.
In various embodiments, any of the compositions described above may include one or more ingredients selected from the group consisting of Hawthorne berry, parsley leaf, marshmallow root, fennel seed, astragalus root, licorice root, suma, cinnamon, celery seed, and alfalfa leaf.
Pharmaceutical Compositions
In some embodiments, the active ingredients and mixtures of active ingredients may be used, for example, in pharmaceutical compositions comprising a pharmaceutically acceptable carrier prepared for storage and subsequent administration. Also, some embodiments include use of the above-described active ingredients with a pharmaceutically acceptable carrier or diluent. Acceptable carriers or diluents for therapeutic use are well known in the pharmaceutical art, and are described, for example, in Remington’s Pharmaceutical Sciences, 18th Ed., Mack Publishing Co., Easton, Pa. (1990), which is incorporated herein by reference in its entirety. Preservatives, stabilizers, dyes and even flavoring agents may be provided in the pharmaceutical composition. For example, sodium benzoate, ascorbic acid and esters of p-hydroxybenzoic acid may be added as preservatives. In addition, antioxidants and suspending agents may be used.
Compositions of the active ingredients may be formulated and used as tablets, capsules, or elixirs for oral administration; suppositories for rectal administration sterile solutions, suspensions for injectable administration; patches for transdermal administration, and sub-dermal deposits and the like. Injectables can be prepared in conventional forms, either as liquid solutions or suspensions, solid forms suitable for solution or suspension in liquid prior to injection, or as emulsions. Suitable excipients are, for example, water, saline, dextrose, mannitol, lactose, lecithin, albumin, sodium glutamate, cysteine hydrochloride, and the like. IN addition, if desired, the injectable pharmaceutical compositions may contain minor amounts of nontoxic auxiliary substances, such as wetting agents, pH buffering agents, and the like. If desired, absorption enhancing preparations (for example, liposomes), may be utilized.