SYNERGISTIC NEUTRACEUTICAL FORMULATIONS

Abstract

One or more synergistic nutraceutical chewable formulations providing enhanced thermogenesis leading to enhanced/improved mental concentration and stamina while minimizing adrenaline and dopamine withdrawal. The primary ingredients comprising caffeine, hordenine, and -phenylethylamine, which are delivered in a chewable form, such as chewing gum, for release and consumption.

Claims

1. A nutraceutical formulation in form providing enhanced thermogenesis, mental concentration, and stamina to mammals, comprising: a. a gum base; b. a glycerine; c. a plasticizer; d. a caffeine with a concentration of 0.0001 grams to 0.3 grams; e. a -phenylethylamine with a concentration of 0.00001 grams to 1 gram; and f. a hordenine with a concentration of 0.00001 grams to 0.1 grams; and wherein the formulation contains only ingredients capable of crossing the blood-brain barrier.

2. The formulation of claim 1, further comprising a sweetener, a flavor, or a coating.

3. The formulation of claim 1, wherein the hordenine is provided as a salt comprising hordenine.

4. The formulation of claim 1, wherein the -phenylethylamine is provided as a salt comprising -phenylethylamine.

5. The formulation of claim 1, further comprising at least one B vitamin.

6. The formulation of claim 1, further comprising a B vitamin complex, the B vitamin complex including B3, B5, B6, B7, B9, and B12 mixed together in any combination.

7. The formulation of claim 1, wherein the caffeine is a green coffee bean extract.

8. The formulation of claim 1, wherein the gum base comprises about 25% to about 35% of the formulation.

9. The formulation of claim 1, wherein the gum base comprises natural latices of vegetable origin or synthetic polymer latices.

10. The formulation of claim 1, wherein the glycerine comprises about 2% to about 10% of the formulation.

11. The formulation of claim 1, wherein the plasticizer comprises about 1% to about 2% of the formulation.

12. The formulation of claim 2, wherein the sweetener comprises about 0.5% to about 1% of the formulation.

13. The formulation of claim 2, wherein the flavor comprises about 1% to about 5% of the formulation.

14. The formulation of claim 9, wherein the natural latices comprise chicle, beeswax, or latex.

15. The formulation of claim 9, wherein the synthetic polymer latices comprise paraffin, butadiene-styrene, vinyl acetate, or polyethylene.

Description

DETAILED DESCRIPTION OF THE EMBODIMENTS

[0019] Before explaining the present disclosure in detail, it is to be understood that the disclosure is not limited to the specifics of particular embodiments as described and that it can be practiced, constructed, or carried out in various ways.

[0020] While embodiments of the disclosure have been shown and described, modifications thereof can be made by one skilled in the art without departing from the spirit and teachings of the disclosure. The embodiments described herein are exemplary only and are not intended to be limiting.

[0021] Specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis of the claims and as a representative basis for teaching persons having ordinary skill in the art to variously employ the present embodiments. Many variations and modifications of embodiments disclosed herein are possible and are within the scope of the present disclosure.

[0022] Where numerical ranges or limitations are expressly stated, such express ranges or limitations should be understood to include iterative ranges or limitations of like magnitude falling within the expressly stated ranges or limitations.

[0023] The use of the word a or an when used in conjunction with the term comprising in the claims and/or the specification may mean one, but it is also consistent with the meaning of one or more, at least one, and one or more than one.

[0024] The word about, when referring to values, means plus or minus 5% of the stated number.

[0025] The use of the term optionally with respect to any element of a claim is intended to mean that the subject element is required, or alternatively, is not required. Both alternatives are intended to be within the scope of the claim. Use of broader terms such as comprises, includes, having, etc. should be understood to provide support for narrower terms such as consisting of, consisting essentially of, comprised substantially of, and the like.

[0026] When methods are disclosed or discussed, the order of the steps is not intended to be limiting, but merely exemplary unless otherwise stated.

[0027] Accordingly, the scope of protection is not limited by the description herein, but is only limited by the claims which follow, encompassing all equivalents of the subject matter of the claims. Each and every claim is hereby incorporated into the specification as an embodiment of the present disclosure. Thus, the claims are a further description and are an addition to the embodiments of the present disclosure.

[0028] The inclusion or discussion of a reference is not an admission that it is prior art to the present disclosure, especially any reference that may have a publication date after the priority date of this application. The disclosures of all patents, patent applications, and publications cited herein are hereby incorporated by reference, to the extent they provide background knowledge; or exemplary, procedural or other details supplementary to those set forth herein.

[0029] Generally, the present disclosure describes synergistic nutraceutical chewable formulations providing enhanced thermogenesis leading to enhanced/improved mental concentration and stamina while minimizing adrenaline and dopamine withdrawal. In most cases these synergistic effects are simultaneous within the consumer's body and are primarily due to the ability to slow the metabolic rate of caffeine and (-phenylethylamine withdrawal when combined with the MAO-B inhibitor, hordenine HCL. It is also clear that combining caffeine, -PEA, and hordenine (likely) results in a synergistic residual reduction in the withdrawal symptoms associated with catecholamine withdrawal following consumption of the beverage formulation(s) due to the increased half-life of -PEA. These symptoms are more fully described below.

[0030] In order to extend physical and mental stamina via thermogenesis and (in some cases) simultaneously reduce unwanted withdrawal symptoms, the present disclosure describes a combination of caffeine, hordenine, and -phenylethylamine (-PEA) in specific doses together with a B-vitamin complex and water with sugars or sugar substitutes (inactives).

[0031] This chewable and/or water-soluble formulation provides not only an increase in thermogenesis associated with a feeling of increased energy due to increased physical metabolic activity, but also stimulates and enhances brain function related to mood and focus. The word complex in this case refers to the use of one or more of the B vitamins as listed below but should not be construed as being a specific combination of B vitamins that has been complexed in any particular combination prior to providing the beverage of the present disclosure.

[0032] The vitamin B portion is also a composition that comprises, in any combination, some of the water-soluble B vitamins, specifically; B3 (Niacinamide) and/ or B6 (pyroxidine hydrochloride), B9, folate (folic acid), B12 (cyanocobalamin), B7 (biotin) and B5 (pantothenic acid). Vitamin B3 can be present in amounts ranging from about 0.002 g to 0.20 g, vitamin B5 as pantothenic acid is present in the ranges from 0.000001 g to 0.100 g, vitamin B6 can be present in amounts ranging from 0.0002 g to 0.20 g, vitamin B7, in the form of Biotin can be present in the amounts ranging from 0.00001 g to 0.01 g, and vitamin B12 can be present in amounts ranging from around 0.000001 g to 0.50 g. Furthermore, vitamin B12 can be dosed as cyanocobalamin (a form that the body readily converts to the active forms methylcobalamin and 5-deoxyadenosylcobalamin). Cyanocobolamin can be converted into methylcobolamin and adenosylcobolamin which can be present in amounts ranging from around 0.000001 g to 0.50 g.

[0033] This product normally would provide active ingredients in chewable form or dispersed in water. Here the term active or actives is meant to convey the meaning of ingredients that are known to provide active stimulation of thermogenesis and/or brain activity when ingested by humans. Alternatively, the term inactive or inactives refer to, for example, a simple carrier or binding agent, such as water or primarily inert fillers such as calcium, magnesium, or sodium salts, thickening agents, emulsifying agents, and buffering agents.

[0034] In embodiments, these formulations utilize only components and compounds extracted or derived from earth grown or naturally occurring earth-available substances.

[0035] In other embodiments, the composition will optionally contain calcium and magnesium salts. Calcium and magnesium salts can be present in amounts ranging from about 0.001 g to 0.50 g,

[0036] More specifically, the present disclosure describes one or more nutraceutical chewable and water-soluble formulations providing enhanced thermogenesis, mental concentration, and stamina to mammals, comprising at least three distinct synergistic components including caffeine, -phenylethylamine, and hordenine, wherein the formulations reduce or eliminate undesirable side effects during or after mammalian ingestion of the formulations.

[0037] Hordenine used is typically hordenine HCl, but not limited thereto. The formulations can comprise -phenylethylamine that is either -phenylethylamine citrate or -phenylethylamine HCl or a combination of both.

[0038] The synergistic components act to increase catecholamine and indoleamine concentrations and the synergism is accomplished as the catecholamine and indoleamine concentrations cross a blood-brain barrier after consumption, thereby reducing or eliminating acute symptoms associated with rapid decline of the catecholamine and indoleamine concentrations in the blood.

[0039] These synergistic components undergo a metabolic breakdown resulting in a controlled decrease in the catecholamine and indoleamine concentrations such that the concentrations revert to a pre-existing basal level associated with the consumer of the beverage formulation.

[0040] These synergistic components provide synergy in that -phenylethylamine decreases serotonin reuptake, hordenine prevents metabolic breakdown of -phenylethylamine and maintains serotonin levels, while caffeine decreases serotonin levels.

[0041] The synergistic component, -phenylethylamine corrects for reduction of serotonin levels that occur following prolonged consumption of caffeine.

[0042] The distinct synergistic components are further combined with one or more B vitamins such that these B vitamins provide additional cognitive enhancing attributes to mental clarity, concentration and stamina. More specifically, the three distinct synergistic components are combined with a B vitamin complex, such that the vitamin B complex includes B3, B5, B6, B7, B9, and B12 mixed together in any combination and at any concentration that will further reduce or eliminate side effects associated with any of the three distinct components and the vitamin B complex during or after human ingestion.

[0043] In embodiments, the three distinct synergistic components are combined with one or more sweeteners including sugars and/or sugar substitutes.

[0044] In embodiments, the formulations can include an addition of flavors, such as natural flavors and/or organic flavors.

[0045] In embodiments, the caffeine used for these beverages is a green coffee bean extract.

[0046] In embodiments, the water can be distilled water, deionized water, buffered water, filtered water or any combination thereof. In this case, the buffered water can be pH adjusted with buffering agents to either increase or decrease pH of the distilled, deionized, and/or filtered water.

[0047] In embodiments, the formulations can include sugars selected from the group consisting of sucrose, crystalline fructose, high fructose syrups, mannose, dextrose, monk fruit sugar, maple syrup, honey, or combinations thereof.

[0048] The sugar substitutes can be selected from: stevia, saccharin, aspartame and sucralose. In the case of stevia, it can be an earth grown derived form of stevia, such as from the stevia leaf.

[0049] In embodiments, these formulations can also contain pharmaceutical grade salts selected from the group consisting of calcium salts, magnesium salts, and sodium salts further enhancing the effects associated with these formulations and combinations thereof. Acceptable salts enhance flavor and efficacy of these formulations specific to improving mental clarity, concentration, and both physical and mental stamina.

[0050] In a separate embodiment, one or more nutraceutical formulations providing enhanced thermogenesis, mental concentration, and stamina, comprising at least three distinct synergistic components including caffeine, -phenylethylamine, and hordenine, provide a boost of energy-generating catecholamines from the caffeine including dopamine and norepinephrine which produces amphetamine stimulation and performance enhancement.

[0051] In this case, the -PEA further promotes an efflux of catecholamines which blocks a re-uptake and simultaneously decreases reuptake of serotonin. This decrease may or may not be simultaneous depending on several factors including the consumer's metabolism, concentration of the synergistic components consumed, and the activity before, during and after the consumer has consumed these beverage formulations.

[0052] In addition, the hordenine stabilizes the -PEA in that the -PEA remains in its pre-consumed form for an extended length of time, normally several hours. Without the addition of hordenine the -PEA would destabilize and become metabolically consumed much more rapidly.

[0053] The -PEA is a stronger NDRI (Norepinephrine-Dopamine Reuptake Inhibitor) and is a weaker-acting SSRI (Selective Serotonin Reuptake Inhibitor) in terms of providing this type of activity across the blood-brain barrier when consumed by the consumer.

[0054] The synergistic action of -PEA with hordenine and caffeine provide prolonged mental and physical benefits and diminish or eliminate unwanted withdrawal symptoms after consumption by reduction of adrenaline and dopamine perturbations.

[0055] In developing these formulations, it has been determined that there are several methods associated with making one or more nutraceutical formulations for increasing thermogenesis.

[0056] One such method comprises providing at least three distinct synergistic components including caffeine, -phenylethylamine, and hordenine, and water, such that the components are provided in powder form to be dissolved in water.

[0057] Additionally, components including sugar, sugar substitutes, B vitamins, colorants and flavorings can be added to the formulations thereby achieving final formulation compositions for consumption.

[0058] These final formulation compositions are used to improve functional conditions in mammals associated with mental clarity, concentration, and stamina.

[0059] In embodiments, the components are provided in chewable form, such as in a chewing gum for release when chewed.

[0060] Consumption of these nutraceutical formulations includes an administration route selected from the group consisting of oral buccal, sublingual, or combinations thereof.

[0061] Most specifically, this disclosure provides for one or more compositions that cause an increase in thermogenesis in mammals, comprising at least caffeine, hordenine and -phenylethylamine and optionally the addition of B vitamins. The caffeine is often sourced from green coffee bean extracts and normally comprises from 0.0001 g to 0.30 g of caffeine from 0.00001 g to 0.1 g of hordenine sourced from barley and from 0.00001 g to 1.0 g -phenylethylamine sourced from cocoa beans.

[0062] The composition can be delivered in chewable form, such as in a chewing gum. In embodiments, the gum can comprise a gum base, a glycerine, and a plasticizer. The gum can also have a sweetener, a flavor, and a coating. Various fillers can be used to achieve desired texture, weight, and other physical characteristics of the gum.

[0063] The gum base is a non-digestible masticatory, or chewable, delivery mechanism for the active ingredients of the present disclosure, i.e., at least caffeine, hordenine, and -phenylethylamine. In embodiments, the gum base can comprise natural latices of vegetable origin or synthetic polymer latices.

[0064] Natural latices of vegetable origin can comprise components such as chicle, beeswax, and/or latex.

[0065] Synthetic polymer latices can comprise paraffin, butadiene-styrene, vinyl acetate, and/or polyethylene. Various usable polymers are known to persons having ordinary skill in the art.

[0066] The chewable composition can further comprise a glycerine, a plasticizer, a sweetener, a flavor, a coating, and/or filler materials.

[0067] It is not the intent of this disclosure to claim a chewing gum, the creation of which is well known to persons having ordinary skill in the art. This disclosure specifically deals with the delivery of the above nutraceutical formulation via a chewable means.

[0068] An exemplary embodiment comprises from about 0.0001 g to about 0.30 g of caffeine, from about 0.00001 g to about 0.1 g of hordenine, from about 0.00001 g to about 1.0 g -phenylethylamine, a gum base from about 25% to about 35%, a glycerine from about 2% to about 10%, a plasticizer from about 1% to about 2%, a sweetener from about 0.5% to about 1%, a flavor from about 1% to about 5%, and a coating as needed.

[0069] While the ranges of caffeine, hordenine, and -phenylethylamine must be maintained, persons having ordinary skill in the art can adjust the composition of the gum delivery mechanism as desired.

[0070] While the present disclosure emphasizes the presented embodiments, it should be understood that within the scope of the appended claims, the disclosure might be embodied other than as specifically enabled herein.