TITLE OF THE INVENTION:
COMPOSITION HAVING THERAPEUTIC AND/OR NUTRITIONALLY ACTIVE SUBSTITUENT
CROSS-REFERENCE TO RELATED APPLICATIONS:
T is application is a coπtinuation-iπ-part of U.S. Patent Application Serial Nc.
09/086,984, filed May 29, 1998, the contents of which is herein incorporated by reference.
FIELD OF THE INVENTION:
The invention relates to compositions having a nutritionally beneficial substituent and a substituent that stimulates a short and/or long term psychological feedback and to vehicles or devices that accomplish the deiiveiγ of the nutritionally beneficial substituent to a recipient.
The invention particularly concerns compositions for oral or translingual delivery using beverages, lozenges and the like ?s vehicles to facilitate delivery. The invention additionally concerns the use of transdermal delivery devices (e.g., patches) to accomplish the delivery of such substituent(s). The invention particularly concerns a formulated, substantially alcohol- free beverage for oral consumption having a nutritionally beneficial substituent and a substituent that stimulates psychological feedback and which accomplishes the oral delivery of the nutritionally beneficial substituent.
BACKGROUND OF THE INVENTION:
For many individuals, adhering to a therapeutic regime or to a daily routine of nutritional supplementation is difficult; it may require a change of habit, or practices, by the consumer. More significantly, nutritional or therapeutic agents may not cause an immediately discernible effect, and, lacking this or other positive feedback, the consumer may discontinue use prematurely. The present invention is directed to this problem.
There are many examples of beverages providing nutritional supplements. U.S. Patent 5,626,849 (Hastings et al.) concerns a composition for facilitating weight loss. The composition contains chromium, L-carnitine, γ-linolenic acid, (-) hydroxycitric acid, choline, inositol, antioxidants and herbs. U.S. Patent 5,567,424 (Hastings) describes a beverage composition containing herbs, fiber, antioxidants and enzymes. U.S. Patent 5,536,506 (Majeed
etai.) αescπbes pipeπne-coπtainiπg compositions. U.S. Patent 5,290,505 (Shapira) concerns a nutritional soft dπnk whose ingredients are said to provide protection from UV damage. The comcosition contains a carotenoid mix and ODtionally, fruit/vegetable juices and/or herbal preparations. U.S. Patent 5,240,732 (Ueda) concerns plant extract-containing beverages supplemented with a sugar-alcohol.
Nutritional supplements having psychological feedback properties have also been described. U.S. Patents 5,681,569 (Kuznicki et al.) and 4,946,701 (Tsai et al.) both concern beverage compositions that contain green tea extracts. U.S. Patent 5,574,522 (Shan et al.) concerns a powdered concentrate containing one or more pharmacologically active agents for use in hot beverages. The composition may contain caffeine, as well as vitamins and minerals. U.S. Patent 5,571,-441 (Andon et al.) is directed to nutπtional supplements comDOSitions that provide psychological feedback.
The disclosed compositions contain vitamins and/or minerals as well as xanthine alkaloids (such as caffeine, etc.) that provide a physiological signal. U.S. Patent 5,114,723 (Stray-Gundersen) concerns hypotonic beverages for supplying physiologically essential electrolytes, nutrient minerals, carbohydrates and other ingredients to a consumer The patent discloses that caffeine may be added to the beverage formulation. U.S Patent 4,992,282 (Mehansho et al.) concerns vitamin and mineral-fortified beverages, which may be supplemented with caffeine. U.S. Patent 4,512,205 (KupDer et al) concerns fruit-flavored carbonated beverages that may be supplemented with caffeine U.S. Patent 4,061,797
(Hannan, Jr. etal.) concerns non-carbonated, caffeinated fruit beve'-ages.
U.S. Patent 4,737,375 (Nakel etal) describes calcium-supplemented beverages. U S. Patent 4,769,244 (Lavie) describes non-hygroscopic water-soluble pulverulent compositions that may be employed to make beverages. Compositions for accomplishing transdermal delivery of pharmaceuticals have also been described (see, for example, U.S. Patents 5,718,914 (Foldvaπ), 5,698,217 (Wilking), 5,721,257 (Baker), 5,683,713 (Blank etal.), and 4,788,189 (Glazer)).
The present invention provides an improved composition for accomplishing the delivery of nutritionally beneficial substituents. In a preferred embodiment, the present invention additionally provides an improved formulated beverage that provides at least one, and most preferably multiple, short and long term psychological feedback(s) to the consumer
SUMMARY OF THE INVENTION:
Conventional or traditional beverages are formulated to provide external sensory appeal (such as taste, sight, or smell). In contrast to such compositions, the present invention provides beverages and other compositions that are formulated to provide internal appeal directly to the brain (i.e., brain rewards). The present invention thus relates to a formulated, defined composition having a nutritionally beneficial substituent and a long and/or short term substituent that stimulates psychological feedback and to vehicles or devices that accomplish the delivery of the nutritionally beneficial substituent. Such preferred compositions will typically possess a nutritionally beneficial substituent and both a long term and a short term substituent that stimulates psychological feedback and which accomplishes the delivery of the nutritionally beneficial substituent. Preferred vehicles include oral and/or translingual delivery vehicles, such as beverages, elixirs, lozenges, chewable tablets, and the like, and transdermal delivery devices such as patches, bandages, etc.
In detail, the invention provides a composition (preferably a formulated beverage (most preferably, substantially alcohol-free) for oral human consumption having a defined composition of substituents comprising: at least one nutritionally beneficial substituent (A) selected from the group consisting of:
Adrenochrome Semicarbazoπe; 5-hydroytryptophan; 5-fluoro-A- methyltrγptamine; 5-fluoro-tiγptophan; 6-fluorotryptophan; tryptophan; acetosalyciiic acid; ibuprophen; acetomiπophen; alfalfa; allocryptiπe; beta- carotene; calcium; caffeine; theophylliπe; theobromine; c oline; chromium picolinate; chromium polynicotinate; diadzin; diadzein; damiana; turnera diffusa; dandelion; evening primrose oil; foiic acid; GABA; ginger; ginkgo biloba; ginseng; glutathione; cysteine; L-glutamine; glycine; N-acetylcysteine;
L-cysteine and L-methionine; S-adenosylmethionine; green tea; guarana; hops; inositol; iron; kava kava; kombucha tea; kudzu; lobelia; glutamic acid; D-phenylalanine; DL-phenylalanine; L-tyrosine; lecithin; linoleic acid; gamma- linoleic acid; magnesium; milk thistle extract (silymariπ); niacin; PABA; protopine; puerarin; pyridoxal-5-phosphate; selenium; soluble fiber; St.
Johnswort; tauriπe; sucrose; fructose; glucose; yellow dock; zinc and zinc picolinate; and zinc polynicotinate;
the substituent being present in an amount sufficient to provide a nutritional benefit to the human recipient; and at least one additional substituent (3) that provides traditional psychological feedback selected from the group consisting of: caffeine or a caffeine equivalent; tryptophan; ephedra; cola; green tea extract; carbonic add; phosphoric acid; citric acid; hops; cocoa; chocolate; an anaπdamide; quinine; malic acid; a sweetener; a fruit juice or fruit juice extract; milk; a vegetable juice or vegetable juice extract; kudzu and 5- hydroxy-tryptophan; the substituent being present in an amount sufficient to provide a sensory psychological feedback.
The invention further provides the above-indicated compositions that additionally contain at least one additional substituent (C) that provides long term psychological feedback and/or at least one additional substituent (D) that provides short term psychological feedback; wherein the substituent (C) that provides the long term psychological feedback is selected from the group consisting of: an anandamide; 5-hydroxytryptophan; 5-fluoro-A-methyltryptamine; 5- fluorotryptophan; 6-fluorotryptophan; tryptophan; allocryptine; caffeine; theophylline; theobromine; California poppy; calcium; chromium picolinate; chromium polynicotinate; chicalote extract; cocoa; chocolate; Damiana ( Turπera diffusa); DL-phenylalanine; ephedra; ephedrine; epinephrine; GABA; ginger; ginseng; L-glutamine; green tea; guarana; kava kava; lactuca virosa; L-tyrosine; lobelia; magnesium; maraba; protopine; pseudophedrine; pseudoepinephrine; pyridoxal-5-phosphate; serotonin; sucrose; fructose; glucose; high fructose corn syrup; red rice yeast; and St. Johnswort; and is present in an amount sufficient to provide a long term feeling of well-being or calmness; and the substituent (D) that provides the short term psychological feedback is selected from the group consisting of: an anandamide; an alcohol enhancer; angelica root; balm; bitter orange (Auranti pericarpium); bogbean; boldo; calamus; California poppy; capsaicum; caraway; cayenne; chamomile; cinchona bark; quinine;
chocolate; cinnamon; clove; cocoa; condurango; dandelion; elecampane; GABA; gentian; ginger; ginseng; holy thistle; hops; horehound; dried lemon peel (Ctrl ericardium); mugwcrt; unripe orange; peppermint; quassia; red sage; rosemary; star anise; thyme; tumeric; wormwood; yarrow; and zinc; and is present in an amount sufficient to provide a short term sensation of warmth, tingling, excitement, tranquiiity and well-being, or a distinctive, intense, bitter or unusual taste.
The invention additionally provides a composition for human consumption, comprising: at least one nutritionally beneficial substituent, the substituent being present in an amount sufficient to provide a nutritional benefit to the human recipient; and at least one additional substituent (C) that provides long term psychological feedback substituent or at least one additional substituent (D) that provides short term psychological feedback; wherein the substituent (C) that provides the long term psychological feedback is selected from the group consisting of: an anandamide; 5-hydroxytryptophaπ; 5-fluoro-A-methyltryptamine; 5- fiuorotryptophan; 6-fluorotryptophan; tryptophan; allocryptine; caffeine; theophylline; theobromine; California poppy; calcium; chromium picolinate; chromium polynicotinate; chicalote extract; cocoa; chocolate; Damiana (Turnera diffusa); DL-phenylalanine; ephedra; ephedrine; epinephrine; GABA; ginger; ginseng; L-glutamiπe; green tea; guarana; kava kava; lactuca virosa; L-tyrosine; lobelia; magnesium; maraba; protopine; pseudophedrine; pseudoepinephrine; pyridoxal-5-phosphate; serotonin; sucrose; fructose; glucose; high fructose corn syrup; red rice yeast; and St. Johnswort; and is present in an amount sufficient to provide a long term feeling of well- being or calmness; and the substituent (D) that provides the short term psychological feedback is selected from the group consisting of: an anandamide; an alcohol enhancer; angelica root; balm; bitter orange (Aurantl pericarpium); bogbean; boldo; calamus; California poppy; capsaicum; caraway; cayenne; chamomile; cinchona bark; quinine;
chocolate; cinnamon; clove; cocoa; condurango; dandelion; elecampane; GABA; gentian; ginger; ginseng; holy thistle; hops; horehound; dried lemon peel (CM pericardium); mugwort; unripe orange; peppermint; quassia; red sage; rosemary; star anise; thyme; tumeric; wormwood; yarrow; and zinc; and is present in an amount sufficient to provide a short term sensation of warmth, tingling, excitement, tranquiiity and well-being, or a distinctive, intense, bitter or unusual taste. The invention additionally provides a method for providing a nutritionally beneficial substituent (A) to a human, comprising administering or providing to the human a composition containing: the nutritionally beneficial substituent (A) in an amount sufficient to provide the nutritional benefit to the human recipient; and at least one additional substituent (C) that provides long term psychological feedback substituent or at least one additional substituent (D) that provides short term psychological feedback; wherein the substituent (C) that provides the long term psychological feedback is selected from the group consisting of: an anandamide; 5-hydroxytryptophan; 5-fluoro-A-methyltryptamine; 5- fluorotryptophan; 6-fluorotryptophan; tryptophan; allocryptine; caffeine; theophylline; theobromine; California poppy; calcium; chromium picolinate; chromium polynicotinate; chicaicte extract; cocoa; chocolate; Damiaπa ( Turnera diffusa); DL-phenylalanine; ephedra; ephedrine; epinephrine; GABA; ginger; ginseng; L-glutamine; green tea; guarana; kava kava; lactuca virosa; L-tyrosine; lobelia; magnesium; maraba; protopine; pseudophedrine; pseudoepinephrine; pyridoxal-5-phosphate; serotonin; sucrose; fructose; glucose; high fructose corn syrup; red rice yeast; and St. Johnswort; and is present in an amount sufficient to provide a long term feeling of well- being or calmness; and the substituent (D) that provides the short term psychological feedback is selected from the group consisting of: an anandamide; an alcohol enhancer; angelica root; balm; bitter orange (Auranti pericarpium); bogbean; boldo; calamus; California poppy;
capsaicum; caraway; cayenne; chamomile; αnchoπa bark; quinine; chocolate; cinnamon; dove; cocoa; condurango; dandelion; elecampane; GABA; gentian; ginger; ginseng; holy thistle; hops; horehound; dried lemon peel (Gtπ pericardium); mug ort; unπpe orange; peppermint; quassia; red sage; rosemary; star anise; thyme; tumeπc; wormwood; yarrow; and zinc; and is present in an amount sufficient to provide a short term sensation of warmth, tingling, excitement, tranquility and well-being, or a distinctive, intense, bitter or unusual taste. The invention additionally provides an aqueous beverage composition for human consumption containing kudzu in liquid form, tryptophan or an analogue thereof, milk thistle, or bioactive zinc dissolved or suspended in water.
The invention also provides a composition for human consumption, comprising two, three, four or five nutritionally beneficial substituents (A) selected from the group consisting of adrenochrome semicarbazone; 5-hydroytryptophan; 5-fluoro-A- methyltryptamine; 5-fluoro-tryptophaπ; 6-fluorotryptophan, tryptophan; acetosalycilic acid; ibuDrophen; acetaminophen; alfalfa; ailocryotine; beta- carotene; calcium; caffeine; theophylline; theobromine, choline, chromium picolinate; chromium polynicotinate, diadzin; diadzein, damiana; turnera diffusa; dandelion; evening primrose oil; foiic aod; GABA, ginger; ginkgo biloba; ginseng; glutathione; cysteine; L-glutamine; glyαne; N-acetylcysteiπe; L-cysteine and l-methionine; S-adenosylmethionine; green tea; guarana; hops; inositol, iron; kava kava; kombucha tea; kudzu; lobelia, glutamic acid; D-phenylalanme, DL-phenylalanine; L-tyrosine; lecithin; linoleic acid; gamma- linoleic aαd; magnesium; milk thistle extract (silymaπn), niaαn; PABA, protopine; pueraπn, pyπdoxal-5-phosphate; selenium; soluble fiber; St.
Johns ort; tauπne; sucrose; fructose; glucose; yellow dock, zinc and zinc picolinate; and zinc polynicotinate.
The invention also provides a composition for human consumption, comprising two, three, four or five nutritionally beneficial substituents (C) that provide long term psychological feedback, wherein said nutritionally beneficial substituents (C) are selected from the group consisting of
an aπanαamide; 5-nydroxytryptophan; 5-fIuoro-A-methyitryptamιne; 5- fluoratryptophan; 6-fIuorotryptophan; tryptophan; allcαyptine; caffeine; theoDhylliπe; theobrom e; California poopv; calαum; chromium picolinate; chromium polynicotinate; chicalote extract; cocoa; chocolate; Damiana ( Tumera dlffυsa); DL-phenylalanine; ephedra; ephedπne; epmephπne;
GABA; ginger; ginseng; L-glutamine; green tea; guarana; kava kava; lactuca virosa; L-tyrosine; lobelia; magnesium; maraba; protopiπe; pseudophedπne; pseudoepineohπne; pyπdoxal-5-phosphate; red πce yeast; serotonin; sucrose; fructose; glucose; high fructose corn syrup; and St. Jonnswort.
DETAILED DESCRIPTION OF THE INVENTION:
The invention relates to formulated, defined compositions having a nutritionally beneficial substituent and a long and/or short term substituent that stimulates psychological feedback, oDttonally in comDination with a substituent that provides a traditional psychological feedback. The invention further relates to vehicles cr cevices that accomplish the delivery of the composition to a recipient. In a more preferred embodiment, the invention concerns such formulated, defined compositions that contain both a short term and a long term substituent that stimulates psychological feedback.
Some imcortant conditions (e.g., alcohol and drug aouse, etc.) are experienced by individuals who may suffer from denial, and do not want to admit to the existence of a problem. By providing positive psychological feedbacks and multiple benefits common to the class, such individuals can be encouraged to imDrove their nutrition for some of the combination of nutritional benefits, without having to face their psychological problems, and thus, as an unintended consequence, be exposed to the proper nutrition for the long term solution to their major problems.
THE DELIVERY VEHICLES OR DEVICES OF THE INVENTION
The compositions of the present invention are formulated or included in vehicles or devices that accomplish their delivery to recipients, and in particular, to recipient humans.
Vehicles suitable for oral or translingual delivery are particularly preferred. A translingual deliver/ vehicle is one a that accomplishes the delivery of the composition via adsorbtion into the tongue, gums or soft tissues of the oral cavity A vehicle suitable for oral delivery is one
that accomplishes the delivery of the composition after ingesti'on. Oral and translingual/transdermal vehicles indude beverages, lozenges, elixirs, syrups, powders, candies, chewable tabiets, etc.
In an alternate embodiment, the delivery of the compositions of the present invention is accomplished using a transdermai delivery device. Such devices indude bandages, patches, implants, etc. that accomplish the delivery of substituents via adsorption through the skin.
The compositions of the present invention are said to be "formulated, defined compositions" by which it is meant that at least two, and preferably all, of their chemical substituents are substantially defined chemically. Thus, although the compositions of the present invention may contain undefined substituents, such as those found in naturally obtainable plant extracts, etc., in all instances they contain at least two chemically ascεrtainable substituents that were deliberately added to the composition in predetermined amounts to achieve preselected concentrations. Where appropriate, the amounts of such substituents in the compositions of the invention will preferably be determined with consideration of the functional concentration (potency) of the substituent.
Beverages for oral administration are the preferred delivery vehicle. As used herein, the term "beverage" is intended to refer to a liquid composition that is in "single" strength form and is ready to drink. Examples of beverage compositions are well known (see, U.S. Patents 4,737,375 (Nakεi et al.), 4, 992,252 (Mehansπo et a!.), 5,583,578 (Heckert et a!.), 5,571,441 (Andcn etal.), each herein incorporated by reference).
The invention contemplates the formulation and use of such beverages, as well as the formulation and use of beverage "concentrates." Such concentrates include solid materials (capsules, tablets, powders, etc.) or solutions, suspensions, or other liquids that require dilution before attaining their desired final state. Such liquid compositions may be formulated from the dissolution or suspension of solid substituents, or from the mixing of liquid substituents, or both. The liquid compositions of the present invention are intended to be orally provided, as distinguished from intravenous or other means.
The beverages of the present invention may be imbibed cooled (as by a refrigerant), or at ambient or elevated temperature (i.e., from about 25 °C to about 180 °C) or at more elevated temperatures (i.e., as a "hot" drink). In a preferred embodiment, the beverages of the present invention are imbibed at temperatures below 180 °C. In a more preferred embodiment, the beverages of the present invention are imbibed at temperatures below 25 °C.
The beverages of the present invention are preferably aicohol-free. They thus contain less than about 10% ethanol, more preferably less than about 5% ethanol, and most preferably are alcohol-free (i.e. only a trace amount of ethanol or none at all). The term "aicohol-free," as used herein, 's intended to be limited to consideration of the ethanol (ethyl alcohol) concentration of the beverage, and not to refer generally to concentrations of other non-ethanol alcohols that may be present. Alternatively, the beverages of the present invention may be alcohol-containing beverages (i.e., a beverage having between about 10% and aDout 40% aicohol).
The beverages of the present invention may be either carbonated or non-carbonated. The term "carbonated" means that the beverage contains both dissolved and dispersed carbon dioxide. Methods of forming carbonated beverages are well known in the art (see, for example, U.S. Patent 4,946,701 (Tsai etal.). Usually, when carbonated, the beverages of the present invention will contain from 1.0 to about 4.5 volumes of carbon dioxide. The preferred carbon dioxide beverages contain from about 2 to about 3.5 volumes of carbon dioxide.
THE COMPOSITIONS OF THE INVENTION
The compositions of the present invention contain at least one substituent selected from a first class of substituents that comprise nutritionally beneficial compounds. Any of a wide array of such substituents may be included in the compositions of the invention. For example, a beverage designed for individuals exhibiting the effects of alconol, or the effects of mood altering prescription or non-prescription drugs (e.g., depressants, narcotics, hallucinogens, stimulants) may contain substituents that may replace depleted nutrients (such as vitamins, minerals, etc.); serve as antioxiαants; improve or repair brain function (e.g., memory, learning, etc.); suppress appetite or alcohol desire; reverse alcohol-related damage; alleviate stress; improve virility; improve or repair liver function, improve or repair immune system responses, alleviate depression; improve or repair blood functions (e.g., oxygen transport, blood sugar level stabilizers, metabolite transport, detoxification, ion balance, etc.).
Substituents that accomplish such goals are well -known in the art. The compositions of the present invention contain at least one, and more preferably 2 or more substituents of this first class. Preferred substituents of this first class, their associated function, and their preferred concentrations ..i the compositions of the present invention are described in Table A. In Table
A, wnere a substituent is indicated to have multiple associated functions, the same concentration of substituent provides all functions, unless a separate dosage is indicated. To
be nutritionally beneficial, as used herein, a substituent is to be provided at a recited concentration, which is the preferred daily intake amount of the substituent The daily intake amount may be obtained by a single serving, etc.,, or by multiple servings, etc.. In a preferred embodiment, the daily intake amount will be delivered in three servings, each compπsing one third of the total preferred intake amount In Table A, the amount/day shown is the most preferred amount per day, unless a maximum, more preferred and/or most preferred amount day is indicated. Where no amount/day is provided, the substituent may be provided in any customary or traditional amount/day.
More Preferred Nutritionally Functional Substituents: In a more preferred embodiment, the compositions of the invention will contain one or more sucn preferred nutritionally beneficial substituents, such more preferred substituents being selected from the group consisting of: Adrenochrome Semicaraazone; 5-hydroytryptocnan or equivalent compounds (e.g.; 5-fluoro-A-methyltryptamιne; 5-fluorotryptophan; 6-fluorotryptopnan; tryptoDhan; etc.); Allocryptiπe; Choline; Diadzin; Diadzein; Damiaπa Turnera Diffusa; Evening Primrose Oil; Giutathione or Giutathione equivalents (e.g.; cysteine; L-glutamine; giycine); Other Giutathione Equivalents: N-acetylcysteine (NAC); L-cysteine -•- L-methionine; S- adenosyimethionine (SAMe); Inositol; Kudzu; Lobelia; Cysteine; Glutamine; L-Methionine; Linoleic Acid; gamma-Linoleic Acid; Magnesium; Milk Thistle Extract (Silymaπn); Niaαn; PABA; Protopine; Puerarin; Pyridoxal-5-Phosphate; soluble fiber; St. Johnswort; Vitamin Bl; Vitamin B5; Vitamin B12; Vitamin C; Vitamin D; Vitamin K; Yellow Dock; and Zinc and Zinc Equivalents (e.g.; zinc picolinate; zinc polynicotinate; etc.).
Hiohlv Preferred Nutritionally Functional Substituents: In a still more preferred embodiment, the compositions of the invention will contain one or more such preferred nutritionally beneficial substituents, such highly preferred substituents being selected from the group consisting of: Adrenochrome Semicarbazone; 5-hydroytryptophan or eαuivalent
compounds (e.g.; 5-fluoro-A-methyltryptamine; 5-fluorotryptophan; 6-fiuorotryptophan; tryptophan; etc.); Allocryptine; Diadzin; Diadzein; Evening Primrose Oil; Other Giutathione Equivalents: N-acεtylcysteine (NAC); L-cysteine + L-methionine; S-adenosylmethionine (SAMe); Kudzu; Lobelia; Milk Thistle Extract (Silymarin); Niacin; Protopiπe; and Puerarin.
The compositions of the invention may contain at least one substituent selected from a second class of substituents that provide a traditional psychological feedback. Any of a wide array of such substituents may be included in the composition. Such substituents will impart a sensory psychological effect to the recipient, such as a pleasant taste, aroma, visual appeal, etc. The compositions of the invention may contain more than one such traditional psychological feedback substituent. Tabie B lists preferred traditional psychological feedback substituents that may be employed in the compositions of the present invention to impart such psychological effect.
Table B Preferred Traditional Psychological Feedback Substituents
Concentration
Substituent (amount/day)
Sweetener (such as caloπc sweeteners (e.g., fructose, high fructose com syrup, suσose, maltose, glucose, lactose, sorbitoi, gaiactose, etc.) or substantially non-caloric sweeteners (e.g., aspartame (and its deπvaπves). sacchaπn, L-suqars. cyclamates, etc.)
Fruit juice or juice extract such as noπ-αtrus fruit juices or juice extracs (e.g., those obtainable from apple, pineapple, grape, pear, banana, pium, cherry, peach, etc.); oerry fruit juices or juice extracts (sucn as those obtainable from strawberry, blueberry, cranberry, blackberry, etc.); or σtrus fruit juices or juice extracts (such as those obtainaole from orange, grapefruit, lemon, lime, etc.)
Milk (including mammalian milk products such as skim milk and cream, and vegetable milks, such as sov milk)
Vegetable juices or juice extracts (such as those obtainable from carrot, tomato, beets, celerv, etc.) kudzu j 5-hydroxy-trvPtθPhan
Spices and plant extract flavoπngs (such as cola, ginger, nutmeg, cecosr vanilla, cnccclate. "ur***, mint, sugar rnaole. heros, etc.).
Synthetically compounded flavorants or naturally isolated flavorants may be employed as such traditional psychological feedback substtuents.
As indicated, the orally or translingually delivered compositions of the present invention may be formulated to contain green tea extract. Green tea helps to control the negative effects of caffeine. See, for example, French patent No. 2,586,532 issued to
Balansard etal.
More Preferred Traditional Psychological Feedback Substituents: In a more preferred optional embodiment, the compositions of the present invention will contain one or more preferred traditional psychological feedback substituents, such more preferred substituents being selected from the group consisting of: Caffeine and caffeine equivalents (e.g.; theophylline; theobromine; related methylxanthines); cola; carbonic acid; phosphoric acid; citric acid; hops; cocoa; chocolate; anandamide; quinine; maiic acid; non-citric fruit juice or juice extract (such as wherein the fruit is grape; apple; cranberry; cherry; peach; etc.); milk;
vegetable juice or juice extract (such as wherein the vegetable is carrot; celery; etc.); kudzu; and 5-hydroxy-tryptophan. hiαrlv Drer~erred Traditional Psychological '■■sedbac Substituents: In a still more preferred embodiment, the compositions cf the present invention will contain one or more highly preferred traditional psychological feedback substituents, such highiy preferred substituents being selected from the group consisting of: Caffeine and caffeine equivalents (e.g.; theoohylline; theobromine; related methylxanthmes) at a concentration/day of greater than about 55 mg; carbonic acid; phosphoric acd; hops; non-citπc fruit juice or fruit juice extract (such as wherein the fruit is grape; apple; cranberry; cherry; peach; etc.); milk, vegetable juice or juice extract (such as wherein the vegetable is carrot; celery; etc.); kudzu; and 5-hydroxy-tryptophan.
The compositions of the invention may contain at least one substituent selected from a third class of substituents that provide long term psychological feedback. Any of a wide array of such substituents may be included in the composition. Such substituents will impart a long term psychological effect to the recipient, such as a feeling of warmth or tingling, of excitement, of tranquillity and well-being, etc. In a preferred embodiment, the compositic is of the invention will contain more than one such long term psychologically active substituent Table C lists particularly preferred long term duration psychological feedback substituents that may be employed in the compos.tiors of the present invention to impart a long e1"'! psychological effect
More Preferred Long Term Psychological Feedback Substituents: In a preferred embodiment, the compositions of the present invention will contain one or more such long term, psychological feedback substituents, such more preferred substituents being selected from the group consisting of: 5-hydroytryptophan or equivalent compounds (e.g.; 5-fluoro-A- methyltryptamine; 5-fluorotryptophan; 6-fIuorotryptophan; tryptophan; etc.); Allocryptine; California Poppy; Chromium (Cr-Picoliπate; Cr-Polynicotinate; (Cr amounts increased with amount of Zn present; decreased for amounts of amino acids)); Cocoa; Damiana ( Turπera diffusa); D-phenylalanine; Ephedra (especially nevadenis); Ephedriπe; Epinephrine; GABA; L- giutamine; Green Tea; Kava Kava; Lactuca Virosa; Lobelia; Magnesium; Maraba; Protopine; Pseudophedrine; Pseudoepinephrine; Pyridoxal-5-phosphate; Red Rice Yeast; Serotonin; St. Johnswcrt; and Vitamin B5.
Highly Preferred Long Term Psychological Feedback Substituents: In a still more preferred embodiment, the compositions of the present invention will contain one or more such long term psychological feedback substituents, such highly preferred substituents being selected from the group consisting of: 5-hydroytryptophan or equivalent compounds (e.g.; 5- fluoro-A-methyltryptamine; 5-fluorotryptophan; 5-fluorotryptophan; tryptophan; etc.); Allocryptine; California Poppy; Chicalote Extract (without toxic substituents); Cocoa; Damiana
(Tumera diffusa); Ephedra nevadenis; Ephedπne; Green Tea; Lactuca Virosa; Lobelia; Maraba; Protopine; Pseudophedrine; Pseudoepinephrine and Red Rice Yeast
The compositions of the invention may contain at least one substituent selected from a fourth class of substituents that provide short term psychological feedback. Any of a wide array of such substituents may be included in the composition. Such substituents will impart a short term psychological effect to the recipient, such as a feeling of warmth or tingling, of excitement, of tranquillity and well-being, etc. In a preferred embodiment, the compositions of the invention will contain more than one such short term psychologically active substituent.
In a particularly preferred embodiment, the compositions of the invention may contain psychologically active substituents that mediate their respective effects in Doth a short duration (i.e., effect completed within 15 minutes of nutritionally beneficial.) and a long term duration (i.e., effect completed after 15 minutes of nutritionally beneficial). Table D lists preferred short term duration psychological feedback substituents that may be employed in the compositions of the present invention to impart a short term psychological effect.
More Preferred Short Term Psychological Feedback Substituents: In a more preferred embodiment, the compositions of the present invention will contain one or more preferred short term psychological feedback substituents, such more preferred substituents being selected from the group consisting of: Anandamide; Alcohol Enhancers, Standard Flavorants; Angelica root; Boldo; California Poppy; Capsaicum; Cayenne; GABA; Gentian; Tumeπc; Vitamin K; and Wormwood.
Hiohlv Preferred Short Term Psychological Feedback Substituents: In a still more preferred embodiment, the compositions of the present invention will contain one or more highly preferred short term psychological feedback substituents, such highly preferred substituents being selected from the group consisting of: an anandamide; an alcohol
enhancer; Angelica root; Boldo; California Poppy; Capsaicum; GABA; Gentian; Tumeric; Vitamin K; and Wormwood.
As indicated above, the invention specifically contemplates compositions containing one or more substituents of substituent classes: (A) that provide nutritional benefit, (B) that provide traditional psychological feedback, (C) that provide long term psychological feedback, and/or (D) that provide short term psychological feedback. Thus, the invention specifically contemplates compositions containing at least one substituent of each of the substituent classes: (A), (B), (C) and (D); (A), (B) and (Q; (A), (B) and (D); (A), (C) and (D); (B), (C) and (D); (A) and (B); (A) and (C); (A) and (D); (B) and (C); (B) and (D); and (C) and (D). The invention further contemplates compositions containing more than one substituent of each of the following substituent classes: (A), (B), (C) and (D); (A), (B) and (C); (A), (B) and (D); (A), (C) and (D); (B), (C) and (D); (A) and (B); (A) and (C); (A) and (D); (B) and (C); (B) and (D); (C) and (D); (A); (B); (C); and (D).
The invention thus specifically contemplates compositions containing: one or more of the above-recited preferred nutritionally beneficial substituents (A), one or more of the above- recited preferred long term psychological feedback substituents (C), and one or more of the above-recited preferred short term psychological feedback substituents (D).
T e invention additionally contemplates preferred compositions containing either one or more of the above-recited mere preferred nutritionally beneficial substituents (A) or one or more of the above-recited highly preferred nutritionally beneficial substituents (A), and one or more of the above-recited preferred long term psychological feedback substituents (B), and one or more of the above-recited preferred short term psychological feedback substituents
(C).
Tne invention additionally contemplates preferred compositions containing one or more of the above-recited preferred nutritionally beneficial substituents (A), and one or more of the above-recited preferred long term psychological feedback substituents (C), and either one or more of the above-recited more preferred short term psychological feedback substituents (D) or one or more of the above-recited highly preferred short term psychological feedback substituents (D). The invention additionally contemplates preferred compositions containing one or more of the above-recited preferred nutritionally beneficial substituents (A), and either one or more of the above-recited more preferred long term psychological feedback substituents (C) or one or more of the above-recited highly preferred long term psychological feedback
substitueπts (C), and one or more of the above-recited preferred short term psychological feedback substituents (D).
The invention further contemplates more preferred compositions containing one or more of the above-recited more preferred nutritionally benefidal substituents (A), and one or more of the aoove-retited preferred long term psychological feedback substituents (C), and one or more of the above-recited more preferred short term psychological feedback substituents (D).
The invention further contemplates more preferred compositions containing one or more of the above-recited preferred nutritionally beneficial substituents (A), and one or more of the above-recited more preferred long term psychological feedback substituents (C), and one or more of the above-recited more preferred short term psychological feedback substituents (D).
The invention further contemplates highly preferred compositions containing one or more of the above-recited highly preferred nutritionally beneficial substituents (A), and one or more of the above-recited preferred long term psychological feedback substituents (C), and one or more of the above-recited highly preferred short term . psychological feedback substituents (D).
The invention further contemplates highly preferred compositions containing one or mere of the above-recited highly preferred nutritionally beneficial substituents (A), and one or more of the above-recited highly preferred long term psychological feedback substituents (C), and one or more of the above-recited preferred short term psychological feedback substituents (D).
The invention further contemplates highly preferred compositions containing one or more of the above-recited preferred nutritionally beneficial substituents (A), and one or more of the above-recited highly preferred long term psychological feedback substituents (C), and one or more of the above-recited highly preferred short term psychological feedback substituents (D).
The invention further contemplates very highly preferred compositions containing one or more of the above-recited highly preferred nutritionally beneficial substituents (A), and one or more of the above-recited highly preferred long term psychological feedback substituents
(C), and one or more of the above-recited highly preferred short term psychological feedback substituents (D).
The invention further contemplates compositions containing two, three, four or more of the above-redted preferred nutritionally benefidal substituents (A), and more preferably two three, four or more of the above-redted highiy preferred nutritionally beneficial substituents (A), and most preferably two, three, four or more of the above-rεcited highly preferred nutritionally beneficial substituents (A).
In all such compositions, traditional psychological feedback substituents (B) may be present.
In accordance with the invention, the compositions of the present invention may additionally contain non-pharmacologicai agents such as stomach acid buffering compounds, antacids, fiber, laxatives, muscle relaxants, analgesics, acetaminophens, ibuprophens, topical antibiotics, anti-inflammatory agents, etc.) at non-prescription levels. In yet another embodiment, the compositions of the invention may be formulated to contain prescription pharmacological agents, such as hormones (e.g., insulin, thyroid hormone, etc.), anti- inflammatory agents, hypertensives, anti-arrhythmias, etc. The co-administration of the compositions of the present invention and such prescription pharmacological agents has the salutary effect of confirming or the consumer's perception or recollection that a dosage has been consumed or administered, and as such aids in preventing overdosing and underdosing by individuals who are self administering such pharmacological agents.
As stated above, in a particularly preferred embodiment, the compositions of the present invention are provided via vehicles for oral or translingual delivery.
In a preferred embodiment, such vehicles are formulated to contain one or more additional substituents selected from the group consisting of: a xanthine alkaloid (such as a methyixanthine (caffeine, theophylline, theobromine, etc.) obtainable synthetically, or by extraction of plants (e.g. coffee beans, cola nuts, tea plants, etc.); carbonic acid, milk, vegetable juice, fruit juice, phosphoric acid, citric acid, hops, cocoa, chocolate, anandamide, quinine and malic acid.
Tne amounts of methyixanthines (and especially caffeine) present in the compositions of the invention are designed to result in the delivery of an amount of such methyixanthines sufficient to impart the desired effect. Thus, where the composition contain compounds that interact (or sequester) such methylxaπthines, proportionately larger amounts of methyixanthine will be included in the composition. Likewise, where the composition contain substituents that enhance the desired effect of a methyixanthine, the amount of the methyixanthine in the composition will be proportionately reduced.
Serotonin, and its precursors, and substituents that stimulate serotonin production and/or release are also preferred substituents of the compositions of the present invention.
The orally or translingually delivered compositions of the present invention may comprise dear solutions, or may be suspensions of particulate mateπal (such as plant pulp or other tissue). When provided as a beverage, such beverages are typically free-flowing and have a viscosity similar to that of water. Preferably, thickening agents are added to impart greater viscosity to the beverages. The beverages of the present invention are typically dispensed and stored in containers (e.g., cardboard containers, glass or plastic bottles, metal cans, etc.).
USES OF THE COMPOSITIONS OF THE INVENTION
The compositions of the present invention provide a nutritionally beneficial substituent to an individual in a manner accompanied by a reinforcing psychological feedback sensation. The psychological feedback sensation imparts an immediate physiological recognition of the composition (such as a feeling of warmth, or a flush feeling) as well as a long term psychological feedback (such as a counter-depressive effect or a sense of well-being). These feedbacks become psychologically associated with the nutritional benefit and the therapeutic activity of the composition and increase an individual's desire to take or use the composition on a regular basis, and thus serve to ensure that the inαivicual obtains a nutritionally beneficial amount of the composition. By the selected inclusion of desired substituents, the compositions of the present invention can be tailored to provide any of a number of desired therapeutic effects. Such effects include blood detoxification; liver repair and detoxification; lessening of a desire to drink alcohol; reversal of alcohol-induced damage; antioxidant activity; alleviating depression, alleviating stress, restoring or improving brain function (such as memory and learning capabilities); suppressing appetite; stabilizing blood sugar levels; improving immune system function and response; etc.
Alternatively, or more preferably, in addition, such compositions can be formulated to contain effective amounts of nutritionally active substituents (such as vitamins, minerals, co- factors, etc.) which build or restore supplies of such substituents damaged by conditions commonly related to each therapy so as to improve the general health of the recipient.
In a preferred embodiment, the compositions of the present invention are formulated to provice a treatment for the conditions associated with alcoholism and/or the effects of
mood alteπng prescription or non-prescription drugs (e.g., depressants, narcotics, hallucinogens, stimulants, etc.). Such compositions, especially beverages are formulated to provide effective amounts of: (1) a liver function reDairant (such as alfalfa, choline, dandelion, gctu kola, .nositol, L-cysteine, L- ethionme, lecithin, milk thistle, niaαn, selenium, vitamin 31, vitamin D, yellow dock, zinc and or zinc picolinate); (2) a substituent for reversing alcohol- related damage (alfalfa, magnesium, vitamin Bl, vitamin D); (3) a substituent for alleviating stress or depression (such as calcium, choline, folic aαd, GABA, ginkgo biloba, ginseng, gotu kola, inositol. DL-phenylalanine, 5-hydroxy-fryptoohan, leαthin, magnesium, PABA, vitamin B3, vitamin B5, vitamin B12, vitamin C), and (4) a substituent for reducing the reαpients desire for alcohol (such as daldzin, foiic acid, giutathione, kudzu, l-glutamιne, L-methionine, St.
Johnswort).
Having now generally described the invention, the same will be more readily understood through reference to the following example which is provided by way of illustration, and is not intended to be limiting of the present invention.
Example 1 Sample Formula
In accordance with the teachings of the present invention, a beverage composition is prepared containing:
Giutamine 3 g
Milk Thistle Seed Extract 2 ml
St. Johnswort Buds Extract 1.5 g
Vitamin C 1.5 g
Vitamin Bυ B^ B3, B5, B0, B12 100 mg of each
Kudzu 3 mg (daidziπ)
5-Hydroxy Tryptophan 150 mg
Ephedra 375 mg
Natural Alcohol Enhancer 0.01%
Water (sweetened)
Sodium Benzoate preservative
The ingredients were obtained as follows: Glutamme (Twiniab Mega Glutamine); Milk Thistle Seed Extract (Gaia 1:1 (80% alcohol)); St. Johnswort Buds Extract (Gaia 1:1 (80% alcohol)); Vitamin C (Twiniab C-1000 cr/stalline); Vitamin B (Twiniab 3-1-group); Kudzu (Nat re's Herbs, 1 mg daidzm, 556 mg cap); Selenium (Solaray 100 meg); Zinc (Twiniab, Zn gluconate, honey and sweetened); 5-Hydroxy Tryptophan (extract Soiaray 100 mg & St.
Johnswort); Ephedra (Solaray 375 mg); Natural Alcohol Enhancer (Quest DY08312 (caDsaicum, ginger, colatile smells); Water (plain rarbonated, sweetened to contain 9.2% sugar).
All ingredients except Natural Alcohol Ennancer and mam liquid with caroonation are dissolved in water sufficient to hold them all in solution. After being vacuum filtered to remove solids, the Natural Alcohol Enhancer and main liquid with carbonation are added. The resulting beverage composition is clear, and has a light yellow color. The beverage has a light licence flavor similar to the flavor of dilute Galiaπo liqueur. The beverage has the flavor of a soft drink, but maintains a bite and nose suggestive of an alcoholic drink. The mild flavor of the beverage can be masked, if desired, with other flavorants. The beverage has a satisfactory shelf-life.
While the invention has been described in connection with specific embodiments thereof, it will be understood that it is capable of further modifications and this application is intended to cover any variations, uses, cr adaptations of the invention following, -n general the principles of the invention and including such departures from the present disclosure as come within known or customary practice within the art to which the inventions pertains and as may be applied to the essential features hereinbefore set forth and as follows in the scope of the appended claims.