COMPOSITION, AND METHOD OF USING THE COMPOSITION, EFFECTIVE FOR MINIMIZING THE HARMFUL EFFECTS ASSOCIATE WITH INDIVIDUALS SUFFERING FROM ALCOHOL INTOXICATION

Abstract

The present invention relates to a composition, and methods of using the composition, for minimizing the harmful effects associated with alcohol consumption. The composition includes a plurality of ingredients, which when combined, have the unexpected effect of increasing one or more metabolic pathways in the individual. As the metabolic rate is increased, alcohol is burned off, or utilized as energy source, and occurs at a considerably much faster rate than under normal physiological means. It is believed that the composition may have an effect on the brain causing it to increase metabolic rates, By administering the composition to an inebriated individual, the rate at which a person sobers up, occurs at a faster rate than would occur under normal physiological time frames.

Claims

1. A composition for improving cognitive performance in an individual suspected of being impaired by an alcoholic substance comprising, at least one cognitive enhancer, at least one neurostimulant, at least one amino acid, at least one mood boosting agent, at least one vitamin, at least one electrolyte, and at least one anti-oxidant, whereby said composition allowing said individual to obtain cognitive capabilities similar to a non-impaired state at a faster rate than can be achieved utilizing normal physiological mechanisms.

2. The composition for improving cognitive performance in an individual suspected of being impaired by an alcoholic substance according to claim 1 further including at least preservative, at least one fiber, and at least one dietary mineral.

3. The composition for improving cognitive performance in an individual suspected of being impaired by an alcoholic substance according to claim 1 wherein said cognitive enhancer is an herbal cognitive enhancer.

4. The composition for improving cognitive ability in an individual suspected of being impaired by an alcoholic substance according to claim 1 wherein said B-vitamins include Vitamin B.sub.1, Vitamin B.sub.2, Vitamin B.sub.3, Vitamin B.sub.5, Vitamin B.sub.6, Vitamin B.sub.12, or combinations thereof.

5. The composition for improving cognitive ability in an individual suspected of being impaired by an alcoholic substance according to claim 1 further including a flavoring agent.

6. The composition for improving cognitive ability in an individual suspected of being impaired by an alcoholic substance according to claim 1 wherein said composition is in the form of a tablet, capsule, caplet, pill, gel cap, dry powder, liquid, or suspension.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0034] In certain embodiments of the present invention, a plurality of ingredients is combined to frJm1 a unique composition. Administering the composition to an individual who is intoxicated or otherwise contains high levels of alcohol in their blood results in increasing the rate of one or more metabolic pathways, thereby decreasing the amount of alcohol in the blood as the metabolic processes use the alcohol as a source of energy. Administration of the composition, therefore, results in breakdown of the alcohol, as well as a removal or reduction of the feeling of inebriation, at a much faster rate than accomplished under normal physiological time frames.

[0035] In certain embodiments, the composition comprises bitter orange. Bitter orange refers to a citrus tree, Citrus aurantium, and its fruit. Although native to east Africa and tropical parts of Asia, Citrus. aurantium is now grown in the Mediterranean regions and parts of the United States. It is also also known as Seville orange, sour orange, Zhi shi, and marmalade orange. Bitter orange is used in a variety of applications including foods, cosmetics, essential oils for perfumes, and aromatherapy products. Bitter orange has been used in traditional Chinese medicine and by indigenous people of the Amazon rainforest for nausea, indigestion, and constipation. The extract of bitter orange peel has been used in dietary supplements as an aid to fat loss and as an appetite suppressant. Bitter orange contains the tyramine metabolites N-methyltyramine, octopamine and Synephrine, substances similar to epinephrine, which acts on the a.sub.1-adrener gic receptor to constrict blood vessels and increase blood pressure and heart rate. Other uses include as a remedy to treat heart burn, nasal congestion, treat fungal infections, as a fat burner, and for increasing mental focus and providing energy. The bitter orange peel is used as an appetite stimulant and for dyspepsia. Bitter orange fruit and peel are also used orally for weight loss, increasing lean body mass, body building, improving athletic performance, nasal congestion, allergic rhinitis, and chronic fatigue syndrome (CFS). The bitter orange flower and its oil are used orally for gastrointestinal (GI) disturbances, duodenal ulcers, constipation, regulating blood lipid levels, lowering blood sugar in diabetes, hyperlipidemia, blood purification, functional disorders of liver and gallbladder, stimulation of the heart and circulation, frostbite, as a sedative for sleep disorders, for kidney and bladder diseases, general feebleness, anemia, imbalances of mineral metabolism, impurities of the skin, hair loss, as a tonic, anti-flatulent, and for cancer. Other uses include administration to relieve prolapsed uterus, prolapsed anus or rectum, diarrhea, and blood in the stools. Topically, bitter orange peel is used for inflammation of the eyelid, conjunctiva, and retina. It is also used for retinal hemorrhage and to relieve exhaustion accompanying colds.

[0036] In certain embodiments, the composition comprises 1, 3 dimethylethylalanine. Alanine is an alpha-amino acid having a chemical formula of CH.sub.3Ch(NH).sub.2COOH. It is a non-essential amino acid found in (bods, and acts as one of the building blocks for proteins.

[0037] In certain embodiments, the composition comprises Hordenine. Hordenine is an ingredient of some plants which are used as food for animals, i.e. in sprouting barley. Hordenine (N,N-dimethyl-4-hydroxyphenylethylamine) is a phenethylamine alkaloid with antibacterial and antibiotic properties. It stimulates the release of non-pinephrine in mammals, working as a stimulant. It is produced in nature by several varieties of plants in the family Cactaceae and by some in Acacia. Hordenine has been promoted as a weight loss agent with the claim that it stimulates the central nervous system. It has also been used as a beta agonist and as a metabolic stimulant. Although little research has been done on hordenine, results of some experiments in pharmacological models show that hordenine is an indirectly acting adrenergic drug. In isolated organs and those structures with reduced epinephrine contents, the hordenine-has been shown to have minimal effect. Experiments in intact animals (rats, dogs) show that hordenine has a positive inotropic effect upon the heart, increases systolic and diastolic blood pressure, peripheral blood flow volume, and inhibits gut movements.

[0038] In some embodiments, the composition comprises green apple pectin, or fibersol, or other fiber source. Pectin in the plant starting material is part of a very complex structure, which gives shape to the soft non-woody parts of the plant It is a structural heteropolysaccharide contained in the primary cell walls of tem:istrial plants. Pectin is a natural part of human diet, but does not contribute significantly to nutrition as it is a soluble dietary fiber. Green apple pectin has been used to absorb metals, toxins, fats, and to reduce heaviness in the blood. Fibersol is a resistant maltodextrin, or alternatively, a digestion resistant maltodextrin. It is 90% resistant to digestion by the human digestive system. Fiber.sol is sold as digestion resistant maltodextrin to dearly define that is it resistant to digestion and that it is not a digestible carbohydrate. It is typically supplied in capsules containing natural, bulk producing, soluble dietary fiber derived from fruit and plants. Each capsule provides the benefits of hemicelluloses (gum and pectin) and polysaccharides which are important for maintaining the proper pace and bulk required for healthy digestive function.

[0039] In some embodiments, the composition comprises N-acetyl L cysteine (NAC). It is a pharmaceutical drug and nutritional supplement which has been used primarily as a mucolytic agent (expectorant), and in the management of paracetamol (acetaminophen) overdose. Other uses include sulfate repletion in conditions, such as autism where cysteine and related sulfur amino acids may be depleted. NAC is a derivative of cysteine in which an acetyl group is attached to the nitrogen atom. It is sold as a dietary supplement commonly claiming antioxidant and liver protecting effects (detoxifying). It is used as a cough medicine because it breaks disulfide bonds in mucus and liquefies it, making it easier to cough up. It is also this action of breaking disulfide bonds that makes it useful in thinning the abnormally thick mucus in Cystic Fibrosis patients.

[0040] In some embodiments, the composition comprises vinpocetine. Vinpocetine is a semi-synthetic derivative alkaloid of vincamine; an extract from the periwinkle plant Vinpocetine has been shown to be a cerebral metabolic enhancer and a selective cerebral vasodilator. Vinpocetine is reported to have cerebral blood flow enhancing and neuroprotective effects, and has been used for the treatment of cerebrovascular disorders and age-related memory impairment. Vinpocetine is marketed as a supplement for vasodilation and as a nootropic for the improvement of memory. Vinpocetine may help support brain functions such as concentration and memory by activating Cerebral metabolism. Vinpocetine has also been identified as a potent anti-inflammatory agent that might have a potential role in the treatment of Parkinson's disease and Alzheimer's disease.

[0041] In some embodiments, the composition comprises tyrosine. Tyrosine (4-hydroxyphenylalanine) is a nonessential amino acid the body makes from another amino acid called phenylalanine. Tyrosine is found in soy products, chicken, turkey, fish, peanuts, almonds, avocados, bananas, milk, cheese, yogurt, cottage cheese, lima beans, pumpkin seeds, and sesame seeds. It is a building block for several important neurotransmitters, including epinephrine, norepinephrine, and dopamine. Tyrosine also helps produce melanin (the pigment responsible for hair and skin color) and helps in the function of organs responsible for making and regulating hormones, including the adrenal, thyroid, and pituitary glands. It is involved in the structure of almost every protein in the body and in the production of the stress hormones epinephrine and norepinephrine. A number of studies have found tyrosine to be useful during conditions of stress, cold; fatigue, loss of a loved one such as in death or divorce, prolonged work and sleep deprivation, with reductions in stress hormone levels, reductions in stress-induced weight loss seen in animal trials, and improvements in cognitive and physical performance seen in human trials,

[0042] In some embodiments, the composition comprises quercetin. Quercetin is a type of plant-based chemical, or phytochemical, known as a flavonoid found in apples, onions, teas, red wines, and many other foods. Flavonoids such as quercetin are antioxidants which scavenge free radicals, the substances which damage cell membranes, tamper with DNA, and even cause cell death Antioxidants can neutralize free radicals and may reduce or even help prevent some of the damage they cause. They also help keep LDL cholesterol from being damaged. Quercetin may have anti-inflammatory properties, It has been promoted as being effective against a wide variety of diseases, including cancer.

[0043] In some embodiments the composition comprises piracetarn, Piracetam chemical name 2-oxo-1-pyrrolidine acetamide, is a nootropic drug. Nootropics are known commonly as cognitive enhancers, improving cognitive functions of the brain such as memory, attention and intelligence. Piracetam improves brain function and stimulates the central nervous system without a..″ly toxicity or addictive properties.

[0044] In some embodiments, the composition comprises B-vitamin mix. B-vitamins are a group of water-soluble vitamins that play important roles in cell metabolism. While originally thought to be a single vitamin, referred to as vitamin B, there exists eight chemically distinct B vitamins, including Vitamin B.sub.1 (thiamine), Vitamin B.sub.2 (riboflavin), Vitamin B3 (niacin or niacinamide), Vitamin B.sub.5 (pantothenic acid), Vitamin B.sub.6 (pyridoxine, pyridoxal, pyridoxamine, or pyridoxine hydrochloride), Vitamin B1 (biotin), Vitamin B.sub.9 (folic acid), Vitamin B.sub.12 (various cobalarnins, commonly cyanocobalamin in vitamin supplements). B vitamins are essential for growth, development, and a variety of other bodily functions. They play a major role in the activities of enzymes, proteins that regulate chemical reactions in the body, which are important in turning food into energy and other needed substances. The B vitamins are thought to be necessary to support and increase the rate of metabolism, maintain healthy skin and muscle tone, enhance immune and nervous system function, promote cell growth and division, including that of the red blood cells that help prevent anemia, and reduce the risk of pancreatic cancer when consumed in food, but not when ingested in vitamin tablet form.

[0045] In some embodiments, the composition comprises an electrolyte mix. Electrolyte refers to salts, specifically ions, which are used by the body's cells (especially nerve, heart, muscle) to maintain voltages across their cell membranes and to carry electrical impulses (nerve impulses, muscle contractions) across themselves and to other cells. One or more of the major electrolytes found in the body may be included in the mix, such as: sodium (Na+), potassium (K+), chloride (Cr), calcium (Ca+.sup.2), magnesium (Mg+.sup.2), bicarbonate (HCO.sub.3″), phosphate (PO/), and sulfate (SO/). The electrolyte mix may include, for example, calcium glycerol phosphate, magnesium glycerol phosphate, potassium glycerol phosphate, or combinations thereof. Other electrolytes known to one of skill in the art may be used as well.

[0046] In some embodiments the composition comprises dimethylethanolamine (DMAE). DMAE, also known as N,N-dimethyl-2-aminoethanol, beta-dimethylaminoethyl alcohol, beta-hydroxyethyldimethylamine and deano!, is an orgrulic compound. It is a choline molecule that has been used to improve memory and concentration. Some studies have shown that fill increase in vigilance and alertness resulted following administration of DMAE, vitamins, and minerals. While long term studies have not been undertaken, nutritional uses for the molecule include boosting immunity, energy, anti-aging effects, weight loss, and aggression.

[0047] In some embodiments, the composition comprises xylitol. Xylitol is an organic compound with the formula (CHOH)3(CH2OH)2. Xylitol is a naturally occurring sugar substitute. It is a sugar alcohol sweetener found in the fibers of many fruits and vegetables, including various berries, corn husks, oats, and mushrooms. Xylitol differs from other sweeteners such as sorbitol, fructose and glucose in that the Xylitol molecule contains five carbons instead of six.

[0048] In some embodiments, the composition comprises potassium bicarbonate. Also known as potassium hydrogen carbonate or potassium acid carbonate, potassium bicarbonate, KHCO3, has been used as a dietary supplement as a source of potassium and as an antacid. Accordingly, the potassium bicarbonate may provide a source of minerals. In some embodiments, the composition may therefore include one or more dietary minerals, i.e. an inorganic element that is essential for human nutrition or promote-certain physiological functions, including but not limited to calcium, phosphorous, selenium, magnesium, potassium, sodium, zinc, and iodine. The dietary mineral may be provided individually or in combination such as a salt containing the mineral element and another ion. roo49J In some embodiments, the composition comprises, in combination, one or more ingredients at for example, concentrations of 100 mg to 1500 mg which act as cognitive enhancers (i.e. substances that improve mental functions such as but not limited to cognition, memory, intelligence, motivation, attention, or concentration), neurostimulants, or combinations thereof. Such ingredients include, but are not limited to, one or more of betaphenethylamine, Sida cordifolia, Ma Huang, ephedra, alkaloids ephedrine, C-AMP-adenosine cyclic 3,5-monophosephate, adrafinil, olmifon, synephrine HCl, methyl synephrine, theobromide, theobromine, evodiamine, octopamine, 1,3 dimethylamylamine, (geranamine, or 1,3 dimethylpentylamine), scbisandra chemensis, Citrus sinensis, paulinia cup.ma, Adhatoda vasica, Visnea mocanera, vWs vinfera, cocoa bean extract, 99% methylxanitines, Evodia rutaecarpa 99% evodiamine, Rauwolscine canescens, raspbeny ketones, tyramine, sulbutiamine, methyl B-12, proactive B-vitamins, Phenylethylamine (PEA), amino acid precursors, Dendrobium nobile (DEN, herb and member of the family Orchidaceae), dihydromyricetin (DHM).

[0049] In some embodiments, the composition comprises one or more ingredients at concentrations of 100 mg to 1000 mg that act as mental focusing agents. Such ingredients include, but are not limited to, one or more of oxytropis falcate, caffeine based or derived stimulants such as yerba mate, chocoamine, theobromine, bromide, guranna. green or black teas, kola nut.

[0050] In some embodiments, the composition comprises one or more amino acids other than described above, particularly those that act as cognitive enhances, improve mental focus, and act as balance enhancers. Such amino acids include, but are not limited to, one or more of L-carnitine in any form, serine in any form, choline in any form, alpha glycerol phosphocholine, and glutamine in any form.

[0051] In some embodiments, the composition comprises herbal substances or compositions such as Milk thistle. Milk thistle, a thistle of the genus Silybum, contains active an flavanoid-Hgnan constituent called silymarin. Such constituent is known to act as an anti-oxidant, and ha..′IJ shown to have liver protective and regenerative properties.

[0052] In some embodiments, the composition comprises stabilizers, which may include preservatives such as but not limited to benzaldehydes, PEG (poly ethyl glycohol), or carboxylicacid.

[0053] The composition can be formulated in any conventional manner. The actual composition may, therefore, be formulated based on the route of administration chosen. Illustrative administration routes include, but are not limited to, oral (such as but not limited to liquid), parenteral (for example, intravenous, intraarterial, subcutaneous, rectal, intramuscular, intraorbital, intracapsular, intraspinal, intraperitoneal, intrasternal), topical (for example nasal, transdermal, intraocular), intravesical, intrathecal, enteral, pulmonary, intralymphatic, intracavital, vaginal, transurethral, intradermal, aural, intramammary, buccal, orthotopic, intrathecal, intralesional, percutaneous, endoscopical, transmucosal, sublingual, and intestinal administration. Accordingly, illustrative examples of the composition form may include but are not limited to tablets, capsules, caplets, pills, gel caps, troches, dispersions, suspensions, liquids, solutions, syrups, or dissolvable strips for placement in the mouth, granules, beads, transdermal patches, gels, powders, pellets, magmas, lozenges, creams, pastes, plasters, lotions, discs, suppositories, liquid sprays for nasal or oral administration, dry powders, dry powder or aerosolized formulations for inhalation, compositions and formulations for intravesical administration.

Example 1: Composition for Improving Cognitive Ability and/or Reducing Blood Alcohol Levels in an Individual Impaired or Suspected of being Impaired by an Alcoholic Substance

[0054]

TABLE-US-00001 Percentage of Overall Compound Composition (by weight or volume) At least one Neurostimulants&fotabolic 40% Stim11lants At least one Cognitive enhancers 20% At least one Amino acids 20% At least one Vitamins and minerals  10%1 At least one_Antioxidants  5% At least one Stabilizers/Preservatives/other  5%

[0055] In an alternative embodiment, the composition for reducing blood alcohol levels. in an individual impaired by an alcoholic substance in accordance with the present invention may comprise about 8 parts by weight of at least one neurostimulant, about 4 parts by weight of at least one cognitive enhancer, about 4 parts by weight of at least one amino acid, about 2 parts by weight of at least one vitamin and/or mineral, about 1. part by weight of at least one antioxidant, and about 1 part by weight of at least one stabilizer.

Example 2: Composition for Improving Cognitive Ability and/or Reducing Blood Alcohol Levels in an Individual Impaired or Suspected of being Impaired by an Alcoholic Substance

[0056]

TABLE-US-00002 Compound Amount Cognitive Enhancers 1.0 mg-1500 mg Neurostimulants and/or Metabolic stimulants 1.0 mg-1500 mg Amino acids 1.0 mg-1000 mg Vitamins 1.0 mg-500 mg  Electrolytes 1.0 mg-500 mg  Minerals 1.0 mg-500 mg  Dietary fiber 1.0 mg-2000 mg Preservatives  1.0 mg-•1000 mg Anti-oxidants 1.00 mg-1000 mg 

Example 3: Oral (Liquid) Composition

[0057]

TABLE-US-00003 Compound Amount Bitter orange 15-1000 mg 1, 3 dimethylethylalanine 15--1000 mg Hordenine 15-1000 mg green apple pectin, or fibersol, or other fiber 500-2000 mg source N-acetyl cysteine (NAC) 250-1000 mg Vinpocetine 10-100 mg Tyrosine 250-1000 mg Quercetin 250-1000 mg Piracetam 250-1000 mg B-v'itamin mix: mixture of one or more of 100-500 mg Vitamin B.sub.1 (thiamine), Vitamin B.sub.2 (riboflavin), Vitamin B3 (niacin or niacinamide), Vitamin B.sub.5 (pantoth(.'1lic acid), Vitamin B5 (pylidoxine, pyridoxal, or pyridoxamine, or pyTidoxine hydrochloride), Vitamin B.sub.7 (biotin), Vitamin B9 (fol:ic add), Vitamin B1.2 (various cobalamins). Electrolyte mix: mixture of one or more of 50-500 mg sodium (Na+), potassium (K+), chloride (Cr), calcium (Ca+.sup.2), magnesium (Mg.sup.2), bicarbonate (.HC03), phosphate (Poi-), and sulfate (soi). Dimethylethanolamine (DMAE) 50-500 III.g Xylitol As needed Potassium bicarbonate As needed Flavoring As needed

Example 4: Oral (Liquid) Composition

[0058]

TABLE-US-00004 Compound Amount Bitter orange 50 mg 1, 3 dimethylethylalanine 30 mg Hordenine 25 mg green apple pectin or fibersol, or other fiber source 1 g N-acetyl cysteine (NAC) 250 g Vinpocetine 10-20 mg Tyrosine 250 mg Quercetin 500 mg Piracetam 500 mg B-vitamin mix: mixture of one or more of Vitamin 250 mg B.sub.1 Vitamin B2, Vitamin Bs, Vitamin B6, Vitamin B12. Electrolyte mix 250 mg Dimethylethano1amine (DMAE) 100 mg Xylitol As needed Potassh.un bicarbonate As needed Lemon-lime or tropical punch As needed

Example 5: Oral (Liquid) Composition

[0059]

TABLE-US-00005 Compound Amount Bitter orange 50 mg 1, 3 dimethylethylalanine 30 mg Hordenine 25 mg green apple pectin 1 g N-acetyl cystt ine (NAC) 250 g Vinpocetine 20 mg N-acetyl-tyrosine 300 mg Quercetin 500 mg Piracetam 500 mg Vitamin Bi 50 mg VitaminB2 50 mg Vitamin 83 200 mg Vitamin Es 50 mg VitaminB6 200 mg Vitamin B12 1000 mg N-acetyl cysteine 250 mg Milk Thistle 300 mg Calcium glycerol phosphate 200 mg Magnesium glycerol phosphate 100 mg Potassium glycerol phosphate 50 mg Dimethylethanolamine (DMAE) 100 mg Xylitol As needed Potassium bicarbonate As needed Flavoring agent As needed

[0060] Methods for Testing of Intoxicated Individuals and Administration of Composition:

[0061] The Example 3 composition was tested in order to observe and record the effects the liquid composition has in relation to individuals Who are intoxicated from drinking beverages containing alcohol. Five individuals, four men and one woman; were used in the test population. Each of the individuals was allowed to consume beverages containing alcohol, such as beer or liquor, over a specific time such that their blood alcohol levels were over the legal driving limits of 0.08. Since a person found driving with a blood-alcohol concentration (BAC) level exceeding the legal limit can be arrested and charged with the offense of driving under the influence (DUI), this was the value chosen as a comparison point. However, the compositions in accordance ‘with the instant invention can be effective in individuals who have lower BAC levels as well. A standard breathalyzer machine, such as the Intoxilyzer 8000 (CMI, Inc. Owensboro, Ky.) or portable breathalyzer machines, such as Ako Hawk (Q3 Asset Acquisition, LLC, Independence, Iowa) which measures the blood-alcohol concentration was used to determine the levels of alcohol in each of the individual's system. In addition to measuring the blood alcohol level, each of the individuals was tested to examine their facultative and physical capabilities in order to determine effects and improvement to the individual's cognitive capabilities or behaviors, Such testing is similar to field sobriety tests performed by police offers in the field when the officers encounter drivers they believe exhibit characteristics of drunk driving, and/or asked to comment about their state of drunkenness. Table 1 below summarizes the results for an individuals that participated in the experiment.

TABLE-US-00006 TABLE 1 Summary: Experimental Results: Time Period Post- ofBAC Admin- Deter- istration Post- mination Pre- of Com- Admin- Post Admin- Drink Post position: istration of istration of .BAC Drink BAC Composition: Com- Subject Level Behavior Levels Behavior position 1. Male 0.18 Feeling of 0.03 Appeared to 16 minutes being drunk exhibit (second post or “buzzed”; normal drink test most likely behavior; of 0.03 at would have increased 45 minutes) failed a field cognitive sobriety test capabilities compared to- impaired state 2. Male 0.21 Feeling of 0.05 Appeared to 16 minutes being drunk; exhibit (second post most likely normal drink test would have behavior; result of failed a field increased 0.05 at sobriety test cognitive 34 minutes) capabilities compared to- imp tE d state 3. Male 0.10 Most likely 0.04 Appeared to 16 minutes would have exhibit failed a field normal sobriety test behavior; increased cognitive capabilities compared to- impaired state 4. Female 0.17 Most likely 0.05 Appeared to 15 minutes would have exhibit (second post failed a field normal drink test sobriety test behavior; result of ! increased 0.05 at cognitive 34 minutes) capabilities compared to- impaired state 5. Male 0.14 Most likely 0.01 Appeared to 15 minutes would have exhibit failed a field normal sobriety test behavior; increased cognitive capabilities compared to- impaired state

Example 1: Subject 1

[0062] Subject Number 1 was allowed to drink beverages containing alcohol. An initial alcohol drunkenness assessment was carried out consisting of both subjective and objective testing means. A standard portable breathalyzer machine was used to determine the levels of alcohol in his system. In addition to the breathalyzer test, Subject Number 1 was visually examined, asked to perform a variety of tests in order to subjectively determine the level of alcohol impairment or intoxication by evaluating his/her coordination, cognitive abilities, and capacity to follow instructions, and/or asked to describe state of drunkenness. After drinking the alcoholic beverages, the initial breathalyzer test indicated a BAC of 0.18. The subject described himself as feeling drunk. After an initial assessment was determined, Subject Number 1 was given an oral dosage of the composition in accordance with Example Number 3. After a period of 16 minutes post administration of the composition, Subject Number 1 was given a second evaluation to determine the level of alcohol impairment As before, the assessment consisted of a determination of the amount of alcohol in the blood through the use of a standard breathalyzer machine, and a subjective test Subject Number 1 had a postadrink breathalyzer test BAC of 0.03 and exhibited normal behavior. A third measurement of RAC levels was determined for Subject Number 1. After a period of 45 minutes after drinking the composition, BAC was measured at 0.03.

Example 2: Subject 2

[0063] Subject Number 2 was allowed to drink beverages containing alcohol. An initial alcohol drunkenness assessment was carried out, consisting of both subjective and objective testing means. A standard portable breathalyzer machine was used to determine the levels of alcohol in his system. In addition to the breathalyzer test, Subject Number 2 was visually examined, asked to perform a variety of tests in order to subjectively determine the level of alcohol impairment or intoxication by evaluating his coordination, cognitive abilities, and capacity to follow instructions, and/or asked to describe state of drunkenness. After drinking the alcoholic beverages, the initial breathalyzer test indicated a BAC of 021. The subject described himself as feeling drunk. After an initial assessment was determined, Subject Number 2 was given an oral dosage of the composition in accordance with Example Number 3. After a period of 16 minutes post administration of the composition, Subject Number 2 was given a second evaluation to determine the level of alcohol impairment. As before, the assessment consisted of a determination of the amount of alcohol in the blood through the use of a standard breathalyzer machine, and a subjective test. Subject Number 2 had a post-drink breathalyzer test BAC of 0.05 and exhibited normal behavior. A third measurement of BAC levels was determined for Subject Number 2. After a period of 34 minutes after drinking the composition, BAC was measured at 0.05.

Example 3; Subject 3

[0064] Subject Number 3 was allowed to drink beverages containing alcohol An initial alcohol drunkenness assessment was carried out, consisting of both subjective and objective testing means. A standard portable breathalyzer machine was used to determine the levels of alcohol in his system. In addition to the breathalyzer test, Subject Number 3 was visually examined, asked to perform a variety of tests in order to subjectively determine the level of alcohol impairment or intoxication by evaluating his coordination, cognitive abilities, and capacity to follow instructions, and/or asked to describe state of drunkenness. After drinking the alcoholic beverages, the initial breathalyzer test indicated a BAC of 0.10. The subject described himself as feeling drunk After an initial assessment was determined, Subject Number 3 was given an oral dosage of the composition in accordance with Example Number 3. After a period of 15 minutes post administration of the composition, Subject Number 3 was given a second evaluation to determine the level of alcohol impairment. As before, the assessment consisted of a determination of the amount of alcohol. in the blood through the use of a standard breathalyzer machine, and a subjective test. Subject Number 3 had a post-drink breathalyzer test BAC of 0.04 and exhibited normal behavior. A third measurement of BAC levels was not determined for Subject Number 3.

Example 4: Subject 4

[0065] Subject Number 4 was allowed to drink beverages containing alcohol. An initial alcohol drunkenness assessment was carried out, consisting of both subjective and objective testing means, A standard portable breathalyzer machine was used to determine the levels of alcohol in her system. In addition to the breathalyzer test, Subject Number 4 was visually examined, asked to perform a variety of tests in order to subjectively determine the level of alcohol impairment or intoxication by evaluating her coordination, cognitive abilities, and capacity to follow instructions, and/or asked to describe state of drunkenness. After drinking the alcoholic beverages, the initial breathalyzer test indicated a BAC of 0.17 The subject described herself as feeling drunk After an initial assessment was determined, Subject Number 4 was given an oral dosage of the composition in accordance with Example Number 3. After a period of 15 minutes post administration of the composition, Subject Number 4 was given a second evaluation to determine the level of alcohol impairment. As before, the assessment consisted of a determination of the amount of alcohol in the blood through the use of a standard breathalyzer machine, and a subjective test. Subject Number 4 had a post-drink breathalyzer test BAC of 0.05 and exhibited normal behavior. A third measurement of BAC levels was determined for Subject Number 4. After a period of 34 minutes after drinking the composition, BAC was measured at 0.05.

Example 5: Subject 5

[0066] Subject Number 5 was allowed to drink beverages containing alcohol. An initial alcohol drunkenness assessment was carried out, consisting of both subjective and objective testing means. A standard portable breathalyzer machine was used to determine the levels of alcohol in his system. In addition to the breathalyzer test, Subject Number 5 was visually examined asked to perform a variety of tests in order to subjectively determine the level of alcohol impairment or intoxication by evaluating his coordination, cognitive abilities, and capacity to follow instructions and/or asked to describe state of drunkenness. After drinking the alcoholic beverages, the initial breathalyzer test indicated a BAC of 0.14. The subject described himself as feeling drunk. After an initial assessment was determined, Subject Number 5 was given an oral dosage of the composition in accordance with Example Number 3. After a period of 15 minutes post administration of the composition, Subject Number 5 was given a second evaluation to determine the level of alcohol impairment. As before, the assessment consisted of a determination of the amount of alcohol in the blood through the use of a standard breathalyzer machine, and a subjective test Subject Number 5 had a post-drink breathalyzer test BAC of 0.01 and exhibited normal behavior. A third measurement of BAC levels was not determined for Subject Number 5.

[0067] While the present invention is susceptible of embodiment in various forms, there is shown and will hereinafter be described a presently preferred, albeit not limiting, embodiment with the understanding that the present disclosure is to be considered an exemplification of the present invention and is not intended to limit the invention to the specific embodiments illustrated.

[0068] All patents and publications mentioned in this specification are indicative of the levels of those skilled in the art to which the invention pertains. AH patents and publications are herein incorporated by reference to the same extent as if each individual publication, was specifically and individually indicated to be incorporated by reference.

[0069] It is to be understood that while a certain form of the invention is illustrated, it is not to be limited to the specific form or arrangement herein described and shown. It will be apparent to those skilled in the art that various changes may be made without departing from the scope of the invention and the invention is not to be considered limited to what is shown and described in the specification and any drawings/figures included herein.

[0070] One skilled in the art will readily appreciate that the present invention is well adapted to carry out the objectives and obtain the ends and advantages mentioned, as well as those inherent therein. The embodiments, methods, procedures and techniques described herein are presently representative of the preferred embodiments, are intended to be exemplary and are not intended as limitations on the scope. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the invention and are defined by the scope of the appended claims; Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. Indeed, various modifications of the described modes for carrying out the invention which are obvious to those skilled in the art are intended to be within the scope of the following claims.