WO2006053217A1 - Composition et procede de perte de poids - Google Patents
Composition et procede de perte de poids Download PDFInfo
- Publication number
- WO2006053217A1 WO2006053217A1 PCT/US2005/040931 US2005040931W WO2006053217A1 WO 2006053217 A1 WO2006053217 A1 WO 2006053217A1 US 2005040931 W US2005040931 W US 2005040931W WO 2006053217 A1 WO2006053217 A1 WO 2006053217A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- composition
- weight loss
- castus
- promoting
- chromium
- Prior art date
Links
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)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/38—Clusiaceae, Hypericaceae or Guttiferae (Hypericum or Mangosteen family), e.g. common St. Johnswort
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/105—Plant extracts, their artificial duplicates or their derivatives
-
- A—HUMAN NECESSITIES
- 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
- A23L33/115—Fatty acids or derivatives thereof; Fats or oils
-
- 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)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
- A61P25/34—Tobacco-abuse
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/04—Anorexiants; Antiobesity agents
-
- A—HUMAN NECESSITIES
- 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
- This invention relates in general to nutraceuticals, including functional foods, dietary supplements, nutritional supplements, medical foods, botanical drugs, and drugs. In particular, it relates to nutraceuticals and methods that are useful for promoting weight loss and weight maintenance.
- Obesity is a serious health problem in the United States and many other countries. About 90 million citizens are now considered obese. Obesity is known to be associated with many serious diseases and metabolic disorders including small, dense LDL syndrome, glucolipoxia, premature aging, memory loss, endothelial dysfunction, vascular disease, hypertension, postprandial hyperlipidemia, insulin resistance, hyperinsulinemia, Syndrome X, hypertriglyceridemia and/or low HDL syndrome, high RQ (respiratory quotient) syndrome, chronic fatigue syndrome, as well as certain types of cancer. In addition, it has psychological implications.
- the invention solves the above and other related problems by the realization that obesity has aspects of addiction.
- the invention provides a weight loss composition and method that addresses the impulsive eating or bingeing aspect of obesity, as well as other addictive behaviors.
- the invention provides new therapeutic, preventive, and weight maintenance strategies that focus upon both direct and indirect modulation of dopaminergic function and restoration of associated brain circuitry.
- the invention provides a weight loss composition and method that modulates the level of brain dopamine (DA), and particularly dopamine type D2 (DA D2) receptors.
- DA brain dopamine
- DA D2 dopamine type D2
- the invention provides a composition for promoting weight loss or weight maintenance, the composition comprising a Vitex agnus-castus (Chastetree berry or Chasteberry) extract in an effective amount for promoting weight loss or weight maintenance.
- the composition further includes: garcinia cambogia; aspartic acid, pyruvate; and EPA (eicosapentanoic acid), preferably in the form of fish oil, and most preferably, dessicated fish oil.
- the composition preferably also includes biotin, L-camitine, and chromium.
- the composition includes Vitex agnus-castus, Garcinia camogia, aspartic acid, pyruvate, EPA, biotin, L-carnitine, and chromium polynicotinate.
- the composition may also include medium chain triglycerides, green tea leaf extract containing EGCG (epigallocatechingallate), and 5-HTP (5- hydroxytryptophan).
- the invention also provides a composition for supporting and promoting a healthy lifestyle free from addictive behavior or for preventing or treating addictive behavior, the composition comprising a Vitex agnus-castus (Chastetree berry or Chasteberry) extract in an effective amount for supporting and promoting a healthy lifestyle free from addictive behavior or for preventing or treating addictive behavior.
- the composition further comprises huperzine in an effective amount for supporting and promoting a healthy lifestyle free from addictive behavior or for preventing or treating addictive behavior.
- the composition further includes biotin, L-carnitine, chromium polynicotinate, aspartic acid, and garcinia cambogia.
- the composition may also include an ingredient selected from the group consisting of: EPA (eicosapentanoic acid), medium chain triglycerides, green tea leaf extract containing EGCG (epigallocatechingallate), and 5-HTP (5-hydroxytryptophan).
- the composition includes Vitex agnus-castus extract and huperzine and further includes an ingredient selected from the group consisting of DMAE (dimethylaminoethanol) and choline.
- DMAE dimethylaminoethanol
- the composition comprises Vitex agnus-castus extract and huperzine, and also includes vitamin B1 , vitamin B2, vitamin B3, vitamin B6, ferrous sulfate, Magnesium, choline, DHA (docosahexanoic acid), and lipoic acid. Additionally, the composition may include taurine.
- the composition of the invention includes Vitex agnus-castus and 5-HTP (5-hydroxytryptophan). Preferably, the composition also includes tyrosine.
- the composition may be included in a delivery vehicle comprising a vehicle selected from the group consisting of an edible film, a breath-care strip, mint or lozenge, a food, a beverage, a spice, a condiment, and a salad dressing.
- the compositions above preferably also include an ingredient selected from the group consisting of glutamate agonists, antagonists, and precursors, GABA agonists, antagonists, and precursors, serotonin agonists, antagonists, and precursors, and agents that affect the levels and interactions of the forgoing ingredients, the ingredient provided in an effective amount for supporting and promoting a healthy lifestyle free from addictive behavior or for preventing or treating addictive behavior.
- compositions above preferably also include ingredients to address nutritional deficiencies due to the addictive behavior, or ingredients to replenish or restore nutrients depleted by drugs taken for the addictive behavior.
- compositions above preferably further include ingredients to replenish nutrients depleted during the withdrawal of any reinforcer that is the object of the addictive behavior.
- the invention also provides a method for supporting and promoting a healthy lifestyle free from addictive behavior or for preventing or treating addictive behavior in a human being, the method comprising orally or parenterally administering to the human being, for an effective period, a composition comprising a Vitex agnus-castus extract in an effective amount for supporting and promoting a healthy lifestyle free from addictive behavior or for preventing or treating addictive behavior in a human being.
- the method further includes administering an ingredient selected from the group consisting of huperzine and 5-HTP (5-hydroxytryptophan), the ingredient provided in an effective amount for supporting and promoting a healthy lifestyle free from addictive behavior or for preventing or treating addictive behavior.
- the method further includes administering an ingredient selected from the group consisting of glutamate agonists, antagonists, and precursors, GABA agonists, antagonists, and precursors, serotonin agonists, antagonists, and precursors, and agents that affect the levels and interactions of the forgoing ingredients, the ingredient provided in an effective amount for supporting and promoting a healthy lifestyle free from addictive behavior or for preventing or treating addictive behavior.
- the method further comprises administering an ingredient selected from the group consisting of: ingredients to address nutritional deficiencies due to the addictive behavior; ingredients to replenish or restore nutrients depleted by drugs taken for the addictive behavior; and ingredients to replenish nutrients depleted during the withdrawal of any reinforcer that is the object of the addictive behavior.
- the invention not only provides a composition for supporting and promoting a healthy lifestyle free from addictive behavior or for preventing or treating addictive behavior in a human being, in particular a composition for promoting weight loss and weight maintenance, it also provides methods of delivering the composition that assist in its daily use. Numerous other advantages and features of the invention will become apparent from the following detailed description.
- addictive behavior includes behavior commonly categorized under the term addiction, as well as impulsive, compulsive, craving, and reward seeking behavior and including behaviors involving the behavioral/cognitive process of assigning importance, maintaining attention, and assessing salience.
- the invention recognizes that the characteristics of compulsive overeating are consistent with at least some of the characteristics of drug-using behavior. Both compulsive overeating and drug addiction manifest the inability to refrain from using a reinforcer, and its compulsive administration. Thus, DA D2 decrements are unlikely to be specific for any one of these compulsive behavioral disorders, including obesity, and may relate to vulnerability for addictive disorders in general. Obese individuals have significantly lower DA D2 receptor levels, as do drug- addicted subjects. Lower DA D2 receptor levels in obese individuals would make them less sensitive to reward stimuli, which would make them more vulnerable to food intake as a means to temporarily compensate for this deficit.
- Increases in DA secondary to phasic DA cell firing plays an important role in coding rewards and reward-associated stimuli, yet do not code exclusively for reward but also for saliency, which in addition to reward includes aversive, novel, and unexpected stimuli. It is proposed here that DA encodes for the motivation to procure the reward in addition to encoding for the reward itself.
- This view about the role of DA in reinforcement provides a different perspective about drugs of abuse, indicating that drugs are reinforcing not just because they are pleasurable but also because by increasing DA they are being processed as salient stimuli that will inherently motivate further drug procurement.
- compulsive behavior such as drug-seeking
- DA which attaches significance to such stimuli
- hypodopaminergic conditions such as various attentional disorders may be unable to attach appropriate salience. It may be, then, that all stimuli are viewed as being equi-salient. This may make it impossible to prioritize, and may provide insight into the inability to focus or choose something specific to focus upon. From this perspective, it is not difficult to imagine a relationship between salience and inattention or impulsiveness. The converse may apply to the compulsive behavior of a drug addict wherein specific behavior (i.e., drug taking) is assigned salience, and is thereby reinforcing.
- specific behavior i.e., drug taking
- PET scans have shown that the reinforcing effects of drugs of abuse are contingent upon large and rapid increases in extra-cellular DA.
- similar studies have also documented a role for DA in motivation, which appears to be encoded by both fast, as well as less dramatic, DA increases. Since DA neurons fire in response to salient stimuli, supra-physiological activation by drugs is likely to be experienced as highly salient, in turn driving attention, arousal conditioned learning, and motivation.
- DA function is markedly disrupted, i.e., decreases in DA release and in DA D2 receptors occur in striatal regions, and this is associated with decreased activity of the orbito-frontal cortex (the neuroanatomical region involved with salience attribution and motivation, and implicated in compulsive behaviors) and the cingulate gyrus (the neuroanatomical region involved with inhibitory control and attention/focus/vigilance and which is implicated in impulsiveness). It is postulated here that decreased DA function results in decreased sensitivity to non drug- related stimuli and disruption of frontal inhibition. Such abnormalities have been described in persons afflicted with attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), and other conditions with altered attention processing, it is, therefore, no surprise that this population suffers from excessive addictive behavior and that appropriate medical therapy diminishes this risk.
- ADD attention deficit disorder
- ADHD attention deficit hyperactivity disorder
- the invention provides new therapeutic, preventive, and health maintenance strategies which focus upon both direct and indirect modulation of dopaminergic function and restoration of associated brain circuitry. This is consistent with the observations that alcohol, cocaine, heroin, marijuana, nicotine use, glucose-bingeing, pathological gambling, excessive video game use, and sex- addiction all cause activation and release of brain DA. These aberrant behaviors, each related to self-fulfillment of a hypodopaminergic trait, may all be combined under the rubric of a reward deficiency syndrome. Extracts from the Chastetree berry (Vitex agnus-castus) are germane in this context. They contain a number of compounds or constituents with dopaminergic properties.
- Vitex agnus-castus extract means any active compound derived from the Vitex agnus-castus plant, which is also referred to as Chastetree, including any compound derived from the Chastetree berry, which may also be referred to as the Chasteberry, and also including any drug or drug ingredient synthesized from the Vitex agnus-castus plant.
- extracts will also be effective in conditions manifesting impulsiveness, inattention, difficulty assigning salience, and the like.
- These extracts may also be combined with additional agents and ingredients having benefit in specific situations; for example, ingredients designed to replenish and restore nutrients or nutritional deficiencies in such addictive individuals, and nutrients depleted during the withdrawal of any drug, nicotine, or other reinforcer that is the object of the addiction.
- compositions according to the invention may be included in foods, "functional foods,” dietary supplements, medical foods, botanical drugs, homeopathic remedies, over-the-counter drugs, prescription drugs, and compounded drugs. They may be useful not only for the treatment of various addictions, but also in the prevention of such behaviors. These extracts and combinations may also be used as appetite suppressants for merely overweight (not obese) individuals, and to restore nutrients depleted in addictive-prone and compulsive individuals, and in those in withdrawal.
- Each formulation is designed to be taken by human beings, preferably on a daily basis, preferably several times per day for at least two weeks, and then thereafter for as long as is required.
- Each formulation includes Vitex agnus-castus, preferably as an extract, administered in capsules, soft gel tablets, liquids, etc., and may include other herbal, botanical, or dietary ingredients of the sort used in and permitted in dietary supplements, and any drug or drug ingredient synthesized from Vitex agnus-castus.
- Administration via the oral, sublingual, subcutaneous, intra-muscular, transdermal, or IV route is anticipated.
- compositions according to the invention may be included with many other combinations of compounds which are beneficial in the conditions listed, including, but not limited to vitamins, minerals, amino acids, and other nutrients and dietary ingredients. They may be included with many other combinations of compounds which are beneficial in the conditions listed for use in compounded drugs, prepared by a compounding pharmacist for a specific individual.
- One skilled in the field, such as a physician may use medical insight, therapeutic skill, prior knowledge, data from the literature, and so forth to compose the specific formulation for a specific individual.
- acetylcholine may modulate dopamine neurotransmission. Therefore, agents that modify cholinergic neurotransmission such as huperzine may be expected to indirectly impact dopaminergic pathways and thereby influence the net effect that administration of Vitex agnus-castus has. This is also true for glutamate agonists, antagonists, and precursors, GABA agonists, antagonists, and precursors, serotonin agonists, antagonists, and precursors, and agents that affect their levels and interactions, and so forth, for most of the known neurotransmitters.
- glutamate agonists, antagonists, and precursors GABA agonists, antagonists, and precursors, serotonin agonists, antagonists, and precursors, and agents that affect their levels and interactions, and so forth, for most of the known neurotransmitters.
- Overweight is a condition associated with the ingestion of a relative excess of calories. Frequently, under such circumstances, food is consumed for reasons other than metabolic need. Under these conditions, it may play a rewarding role and be associated with DA release.
- the provision of an extract of Vitex agnus- castus alone, or in combination with other agents, may substitute for the foodstuffs as a reinforcer and would act to diminish the reliance upon food, thereby facilitating subsequent weight loss.
- Vitex agnus-castus capsules (standardized to casticin) - 200 mg taken orally twice per day
- Aspartate may be used in place of the aspartic acid.
- the EPA is preferably provided in the form of fish oil, and preferably dessicated fish oil.
- Green tea leaf extract containing 100 mg of EGCG (epigallocatechingallate)
- Each dose or serving size consisting of Vitex agnus-castus (standardized to casticin) - 50 mg
- Formulation 1 Vitex agnus-castus (standardized to casticin) - 100 mg per dose or serving size to be taken two or three times per day.
- Formulation 4 As in Formulations 2 or 3 above, but also including per dose or serving size:
- 5-HTP (5-hydroxytryptophan) 250 mg
- compositions according to the invention are preferably administered via the oral, sublingual, subcutaneous, intra-muscular, transdermal, or IV route.
- Such "formal" administration may not be effective, in that taking a dose of a "medicine” each day is difficult enough for healthy people, much less addicts. Therefore, the invention contemplates Inclusion of any of the above compositions in foods, drinks, wafers, chewable formulations, gum, candy, bars, powdered shakes, meal replacements, dietary supplements, etc., as well as inclusion in functional foods, medical foods, drugs, etc.
- the delivery vehicle may comprise an edible film, a breath-care strip, mint or lozenge, or a food, water, beverage, spice or other food additive, condiment, or salad dressing or other functional food.
- the preferred foods are: energy bars, salad dressings, condiments (such as steak sauce, mustard, catsup, and soy sauce), vegetable oils, fruit products (such as jellies, jams and syrups), cereals, trail mix, cookies, pasta, flours (including wheat, soy, oat, and potato flour), whey, chocolate, yogurt, tofu, bagels, baked goods, vegetables, soups, nutritional bars, snacks, crackers, meats, and meat products such as lunch meats, and milk products such as ice cream, cheese, and butter.
- the term "beverage” is used in its common meaning, which does not include water or medicines.
- the preferred beverages are sports drinks, soft drinks, alcoholic beverages, tea, coffee, milk, and fruit juices.
- compositions and methods for dietary supplements to restore nutritive balance, and nutrients lost or depleted during any protocol to address or "break" an addiction are also contemplated.
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Abstract
Applications Claiming Priority (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/986,924 US20050129783A1 (en) | 2001-04-19 | 2004-11-12 | Composition and method for treatment of neurophysiological conditions and maintenance of neurophysiological health |
US10/986,924 | 2004-11-12 | ||
US10/987,108 | 2004-11-12 | ||
US10/987,108 US20050095233A1 (en) | 2000-12-28 | 2004-11-12 | Composition and method for reducing lipid storage |
US11/111,542 US20060105062A1 (en) | 2004-11-12 | 2005-04-21 | Composition and method for modulating addictive behaviors |
US11/111,542 | 2005-04-21 |
Publications (1)
Publication Number | Publication Date |
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WO2006053217A1 true WO2006053217A1 (fr) | 2006-05-18 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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PCT/US2005/040931 WO2006053217A1 (fr) | 2004-11-12 | 2005-11-12 | Composition et procede de perte de poids |
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WO (1) | WO2006053217A1 (fr) |
Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1998002165A1 (fr) * | 1996-07-17 | 1998-01-22 | Nutracorp Scientific, Inc. | Coupe-faim |
WO1999008681A1 (fr) * | 1997-08-13 | 1999-02-25 | Nutracorp Scientific, Inc. | Induction de neurotransmetteurs et d'activite neuropeptidique |
WO2002030404A2 (fr) * | 2000-10-12 | 2002-04-18 | Bioriginal Food & Science Corporation | Therapie combinee destinee aux symptomes premenstruels |
US20020122834A1 (en) * | 2000-12-22 | 2002-09-05 | Trant Aileen Sontag | Method and composition for improving fertility health in female and male animals and humans |
WO2002074321A1 (fr) * | 2001-03-21 | 2002-09-26 | N.V. Nutricia | Composition comportant du cacao et un agoniste du recepteur d2 de la dopamine |
WO2003068199A1 (fr) * | 2002-02-15 | 2003-08-21 | Bionorica Ag | Utilisation d'extraits contenant des phytooestrogenes modulant de maniere selective le recepteur beta d'oestrogenes |
US20050260285A1 (en) * | 2004-05-21 | 2005-11-24 | Dimateeo-Leggio Giovina | Healthy prostate formula |
-
2005
- 2005-11-12 WO PCT/US2005/040931 patent/WO2006053217A1/fr active Application Filing
Patent Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1998002165A1 (fr) * | 1996-07-17 | 1998-01-22 | Nutracorp Scientific, Inc. | Coupe-faim |
WO1999008681A1 (fr) * | 1997-08-13 | 1999-02-25 | Nutracorp Scientific, Inc. | Induction de neurotransmetteurs et d'activite neuropeptidique |
WO2002030404A2 (fr) * | 2000-10-12 | 2002-04-18 | Bioriginal Food & Science Corporation | Therapie combinee destinee aux symptomes premenstruels |
US20020122834A1 (en) * | 2000-12-22 | 2002-09-05 | Trant Aileen Sontag | Method and composition for improving fertility health in female and male animals and humans |
WO2002074321A1 (fr) * | 2001-03-21 | 2002-09-26 | N.V. Nutricia | Composition comportant du cacao et un agoniste du recepteur d2 de la dopamine |
WO2003068199A1 (fr) * | 2002-02-15 | 2003-08-21 | Bionorica Ag | Utilisation d'extraits contenant des phytooestrogenes modulant de maniere selective le recepteur beta d'oestrogenes |
US20050260285A1 (en) * | 2004-05-21 | 2005-11-24 | Dimateeo-Leggio Giovina | Healthy prostate formula |
Non-Patent Citations (2)
Title |
---|
HOBERG E ET AL: "Diterpenoids from the fruits of Vitex agnus-castus", PHYTOCHEMISTRY, PERGAMON PRESS, GB, vol. 52, no. 8, December 1999 (1999-12-01), pages 1555 - 1558, XP004291171, ISSN: 0031-9422 * |
LIU J ET AL: "EVALUATION OF ESTROGENIC ACTIVITY OF PLANT EXTRACTS FOR THE POTENTIAL TREATMENT OF MENOPAUSAL SYMPTOMS", JOURNAL OF AGRICULTURAL AND FOOD CHEMISTRY, AMERICAN CHEMICAL SOCIETY. WASHINGTON, US, vol. 49, no. 5, 2001, pages 2472 - 2479, XP001068359, ISSN: 0021-8561 * |
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