WO2018112475A1

WO2018112475A1 - Energy compositions and methods

Info

Publication number: WO2018112475A1
Application number: PCT/US2017/067116
Authority: WO
Inventors: Scott Martin
Original assignee: Hempep, Inc.
Priority date: 2016-12-16
Filing date: 2017-12-18
Publication date: 2018-06-21

Abstract

Energy enhancing compositions and methods comprise plant stimulant, theacrine and cannabis components in ratios such that the theacrine component enhances a beneficial effect of the plant stimulant component, and the cannabis component reduces a negative effect the plant stimulant component. Contemplated compositions can further comprise one or more of a green tea component, a ginger component, a turmeric component and a vitamin component to further enhance the beneficial effect of the plant stimulant component.

Description

ENERGY COMPOSITIONS AND METHODS

[0001] This application claims the benefit of priority to U. S. Provisional Patent Application Number 62/435,354, filed December 16, 2016, which is incorporated by reference herein in its entirety.

Field of the Invention

[0002] The field of the invention is dietary supplements, especially dietary supplements providing an energy enhancing effect.

Background

[0003] The following background discussion includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.

[0004] Many individuals of all ages and gender suffer at least at some point from chronic or transient lack of energy, or fatigue. Generally, such lack of energy or fatigue can be treated with natural mechanisms restoring energy such as sleep, or via changes in physical metabolism through exercise or healthy diet. However, such natural mechanism or long-term changes of physical metabolism may not be helpful for some people who need to enhance their energy at least temporarily and immediately. Thus, many people have long relied on quick energy boosters such as coffee, caffeine pills, energy supplements, ginseng, and energy bars. Yet, many of such quick energy boosters, especially those having high caffeine content cause various side effects to the consumer, including nervousness, restlessness, stomach irritation, nausea, and increased heart rate and respiration.

[0005] Yerba mate is a plant stimulant that is relatively high in caffeine content and has gained popularity in recent years as an energy enhancing stimulant. Yerba mate is believed to offer a wide variety of benefits, for example, relief of mental and physical fatigue, improvement in mood and depression, appetite suppression and fat burning capabilities. Although yerba mate is thought to be safe when consumed in low or moderate amounts, similar to other caffeine-containing foods or drinks, its consumption in larger doses often causes several undesired symptoms such as jitters, anxiety, cardiac effects (e.g., increased heart rate, increased blood pressure), nervousness, restlessness, osteoporosis, irritable bowel syndrome and even certain forms of cancers. These negative effects associated with yerba mate can be exacerbated when consumed as a tea or in combination with certain medications, cigarettes or alcohol.

[0006] In other known energy formulations, selected cannabinoids were combined with a caffeinated ingredient such as yerba mate. Cannabinoids have been generally known as having a calming effect, including sleep induction sleep, preventing nausea, and relieving pain, as opposite to caffeine. For example, U.S. Pat. Pub. No. 2016/0324776 to Glatzel teaches that a combination of yerba mate and cannabinoids would provide both alertness and a calming effect. Similarly, U.S. Pat. Pub. No. 2016/0324776 to Victor, discloses a yerba mate drink containing cannabinoid compounds. However, much of the stimulant effect of the yerba mate will be blunted by the sedative effect of cannabinoids, unless very large quantities of yerba mate would be included (which would counteract the sedative effect of the cannabinoids. Notably, both Glatzel and Victor do not provide any concentrations of yerba mate and cannabinoid to provide both alertness and calming effect at a desired level, and even fail to indicate whether a combination of yerba mate and cannabinoids would be even sufficient to provide both alertness and calming effect at any desired level.

[0007] Thus, there is still a need in the art for improved energy boosting compositions that provide desired stimulating effects without undue side effects.

Summary of the Invention

[0008] The inventive subject matter is directed to various compositions of, methods for, and uses of a combination of a plant stimulant, a theacrine containing component, and a cannabis component to provide a consumer sufficient energy-enhancing effect while reducing undesired effects of stimulants.

[0009] To that end, the inventors surprisingly discovered that the energy boosting effects of yerba mate extract or other plant stimulant components can be substantially enhanced by the addition of a theacrine containing component (e.g., TeaCrine®). Thus, compositions including a combination of yerba mate extract and theacrine can include a lower dose of yerba mate when compared to known oral yerba mate formulations, while providing substantially the same or even greater energy boosting effects. Therefore, energy boosting effects of yerba mate components can be obtained even at large doses without the negative effects associated with larger doses of yerba mate. In addition, the inventors unexpectedly discovered that combining a cannabis component, and particularly cannabidiol (and/or other non-psychotropic cannabinoids) with yerba mate in combination with a theacrine containing component substantially maintains the substantially enhanced stimulant effect while reducing undesirable side effects of the stimulating component(s).

[0010] Thus, one aspect of the subject matter includes an oral composition including a plant stimulant component, a theacrine containing component, and a cannabis component. In this composition, the theacrine containing component is present in an amount sufficient to enhance a first effect of the plant stimulant component and the cannabis component is present in an amount effective to reduce a second effect of the plant stimulant component. Typically, the plant stimulant component is obtained from a yerba mate leaf extract, and the theacrine containing component can be obtained from Camellia Kucha tea leaves. Additionally, the oral composition can further include a ginger component, a turmeric component, and a vitamin B component.

[0011] In another aspect of the inventive subject matter, the inventors contemplate an oral composition that includes a yerba mate component, a Camellia Kucha component, and a cannabidiol fraction. In this composition, the Camellia Kucha containing component is present in an amount sufficient to enhance a first effect of the yerba mate component and the cannabidiol fraction is present in an amount effective to reduce a second effect of the yerba mate component. Additionally, the composition may further include at least one of, or a plurality of a green tea component, a ginger root component, a curcumin component, and a vitamin B component.

[0012] In still another aspect of the inventive subject matter, the inventors contemplate an oral composition that comprises a stimulant composition that essentially consists of a plant stimulant component, a theacrine containing component, and a cannabis component. In this composition, the theacrine containing component is present in an amount sufficient to enhance a first effect of the plant stimulant component and the cannabis component is present in an amount effective to reduce a second effect of the plant stimulant component.

[0013] Additionally, the inventors contemplate use of above oral compositions for treating or reducing stimulant addiction.

[0014] Still another aspect of the inventive subject matter includes a method of modifying activity of a yerba mate component containing mixture for an oral composition. In this method, a theacrine containing component is added to the mixture in an amount effective to enhance an energy improving effect of the yerba mate plant component. Preferably, the mixture for the oral composition includes a cannabis component to reduce a negative effect of the yerba mate plant component. Additionally, the oral composition can further include a ginger component, a turmeric component, and a vitamin B component.

[0015] Still another aspect of the inventive subject matter includes a method of modifying an activity of a mixture for an oral composition. The mixture for an oral composition includes a yerba mate component and a theacrine containing component, and theacrine containing component is present in an amount sufficient to enhance an energy improving effect of the yerba mate component . In this method, a cannabis component to the mixture in an amount effective to reduce a negative effect of a combination of the theacrine containing component and the yerba mate component present in the mixture

[0016] In still another aspect of the inventive subject matter, the inventors contemplate a method of enhancing an energy level in a person. In this method, an oral composition comprising a plant stimulant component, a theacrine containing component, and a cannabis component is formulated or provided. As used herein, the term "provide" or "providing" refers to and includes any acts of manufacturing, generating, placing, enabling to use, or making ready to use. Most preferably, the theacrine containing component is present in an amount effective to modify an energy increasing capability of the plant stimulant component, and the cannabis component is present in an amount effective to reduce a negative side effect of at least one of the plant stimulant component and the theacrine containing component. Then, a dose of the oral composition effective to enhance the energy level of the person can be administered to the person to enhance the energy level of the person, while, preferably, reducing a negative side effect of at least one of the plant stimulant component and the theacrine containing component.

[0017] Various objects, features, aspects and advantages of the inventive subject matter will become more apparent from the following detailed description of preferred embodiments.

Detailed Description

[0018] The inventors have surprisingly discovered that various components can be combined with plant stimulant components to thereby provide formulations having substantial energy boosting capabilities without substantial, or with substantially reduced negative effects. More specifically, a theacrine component and a cannabis component can be combined with a plant stimulant component, such that the theacrine component is effective to enhance and/or prolong a desired effect of the plant stimulant component (e.g., energy boost, appetite suppression, improved mood, etc.), and the cannabis component is effective to reduce a negative effect of the plant stimulant component (e.g., jitters, nervousness, anxiousness, fear, etc.) without substantially affecting the desired effect.

[0019] Preferably, the plant stimulant component includes a yerba mate (also known as Ilex paraguariensis) leaf extract. Any suitable methods of producing the yerba mate extract are contemplated. In one example, the yerba mate extract can be generated from fresh leaves of yerba mate plant or a dried (at least 30% dried, at least 50% dried, at least 90% dried, at least 99% dried) leaves of yerba mate plant. The yerba mate extract can be a crude extract (aqueous, alcoholic, or non-aqueous) that contains a mixture of xanthines (e.g., caffeine), flavonoids (e.g., quercetin), saponins (e.g., ursolic acid), and/or cinnamic acid (e.g., chlorogenic acid) compounds at a natural concentration or at ratios that are naturally present in the yerba mate plant leaves. However, it is also contemplated that the yerba mate extract can be an extract with a boosted amount of xanthines (e.g., caffeine), flavonoids (e.g., quercetin), saponins (e.g., ursolic acid), and/or cinnamic acid (e.g., chlorogenic acid) compounds by, for example, artificially adding one or more of those compounds or extracted using a protocol to remove or concentrate one or more of those compounds. Most typically, the extracts will be standardized to a specific caffeine concentration (e.g., to contain 5 wt%, 10 wt%,15 wt%, or 20 wt%, caffeine). It is contemplated that the theacrine containing component can additionally potentiate the duration of an effect of the plant stimulant component. Viewed form a different perspective, it should be appreciated that theacrine acts as a synergistic component for the stimulant effect of the plant stimulant, and particularly for the yerba mate extract. The theacrine component can be any components including, or derivative component including 1,3,7,9-tetramethyluric acid (a caffeine derivative) or the derivative thereof, in a liquid or a solid form. Most typically, the theacrine component can be obtained or derived from Chinese tea known as kudingcha (Camellia assamica var. kuch , or Camellia Kucha), or its extract. In some embodiments, the theacrine component can be an extract (aqueous or non-aqueous) of Camellia Kucha, generated from fresh leaves of Camellia Kucha or a dried (at least 30% dried, at least 50% dried, at least 90% dried, at least 99% dried) leaves of Camellia Kucha. In other embodiments, the theacrine component can be a purified chemical or a chemical mixture that has 1,3,7,9-tetramethyluric acid at a concentration of higher than 10%, higher than 20%, higher than 30%, higher than 50% , or higher than 70%, etc. For example, and among other contemplated aspects, the theacrine component may be TEACRIN® (theacrine supplement available from Double Wood Supplements, 3510 Scotts Lane, Philadelphia, PA 19128)

[0020] It is especially preferred that the theacrine component and the yerba mate component are present in the composition in synergistic amounts (e.g., ratio, weight/volume, etc.) with respect to at least one desired effect, including, but not limited to enhanced energy levels, appetite suppression, fat burning capabilities, improved mood or motivation, or heightened mental focus. For example, while the beneficial effects of yerba mate components can typically last for about 1 hours when consumed without a theacrine containing component, formulations including both yerba mate and theacrine components can prolong the beneficial effects for at least 2 hours, at least 4 hours, at least 5 hours or even 6 or more hours. In addition, it is also preferred that theacrine component and the yerba mate component are present in the composition in an amount or ratio that does not significantly change (or negatively affect) any vital signs (e.g., blood pressure, respiratory rate, pulse rate, body temperature, etc.) quantitatively or qualitatively. .

[0021] The inventors contemplate that increases in beneficial effects of yerba mate component such as enhanced energy levels are typically accompanied by increases in adverse effects, especially jitteriness, anxiety, and nervousness. In some embodiments, the inventors further contemplate that by adding the theacrine components in the composition, the amount of the yerba mate component in the composition can be decreased as 1 ,3,7,9-tetramethyluric acid of the theacrine components can provide a similar effect with the caffeine of the yerba mate component. Thus, without wishing to be bound by any specific theory, the beneficial effect of the composition can be prolonged, but the negative or undesired effect of the composition can be decreased as the relative concentration of the yerba mate component can be decreased with increased theacrine component concentration.

[0022] Alternatively and additionally, the inventors found that the adverse or undesired effect of yerba mate components can be effectively counteracted , by including a hemp oil concentrate or other cannabis component in the composition, preferably at an amount effective to reduce some or all of the negative side effects of the yerba mate component. Additionally, the cannabis component can soften the effects of coming down after the energy boost provided by the yerba mate and theacrine components, making the come down much more subtle, gradual and tolerable. Most typically, the cannabis component can comprise at least one of a cannabidiol, a tetrahydrocannabinol, a cannabinol, a cannabichromene, and a cannabigerol. For example, a cannabidiol hemp oil concentrate (e.g., HempCHOICE® produced by Source 1 Global Partners) could be present in the composition in an amount sufficient to reduce the jitters, anxiety, nervousness or nausea caused or enhanced by the yerba mate component in the consumers.

[0023] In some preferred aspects, the hemp oil concentrate has a high CBD (cannabidiol) content and a low THC (tetrahydrocannabinol) content. Preferably, the cannabis component comprises a cannabidiol with less than 3 wt% of THC, and typically less than 1 wt% of THC, even more typically less than 0.5 wt% of THC, and most typically less than 0.25 wt% of THC (e.g., formulated with C02 extraction). With presect to suitable quantities of cannabidiol it is generally preferred that the high-CBD content is at least 10 wt%, more typically at least 15 wt%, even more at least 20 wt%, and most typically at least 25 wt%. The high CBD/low THC cannabis component can be obtained from a high CBD/low THC cannabis strains, or can be obtained by processes that remove THC content or convert THCs into CBDs.

[0024] It should be appreciated that one having ordinary skill in the art would generally not contemplate the use of cannabis components in combination with an energy boosting and appetite suppressing component since cannabis components are known to have sedative effects, a reduction in motivation, and an increase in appetite, anxiety and depression.

Further, even if one having ordinary skill in the art would contemplate use of cannabinoid component with energy boosting component (e.g., theacrine component or yerba mate component, or both), one would not readily contemplate that a composition can be formulated such that the effect of an energy boosting component can be maintained (or even boosted further) while the undesired side effect can be substantially reduced as two or more components having opposite effects can often compromise their effects rather than selectively strengthen or weakening the desired or undesired effects, respectively.

[0025] It is contemplated that the yerba mate or other plant stimulant component and the cannabis component can be present in any suitable weight ratio or molar ratio to reduce the negative effects of the plant stimulant component. Of course, it may vary depending on the types of plant stimulant component and the cannabis component and the initial concentration of xanthines (e.g., caffeine) and CBD in those components, respectively. For example, where the plant stimulant component is a yerba mate leaf extract and the cannabis component is a hemp oil concentrate, the ratio between the yerba mate leaf extract and the hemp oil concentrate can be between 4: 1 and 12: 1, preferably between 6: 1 and 10: 1, more preferably between 7: 1 and 9: 1 , and most preferably around or about 8: 1. However, it is also contemplated that the weight ratio of the plant stimulant component can be lower than the cannabis component if the cannabis component has lower concentration of CBD and the plant stimulant component has higher concentration of caffeine or chemicals with similar characteristics. Thus, in this embodiment, the ratio between the plant stimulant component and the cannabis component can be between 1 :4 and 1 : 12, between 1 :6 and 1 : 10, and between 1 :7 and 1 :9.

[0026] Most preferably, the yerba mate component is mixed with the theacrine containing component to produce synergistic effect of boosting the energy in a consumer, and further mixed with the cannabis component to reduce the negative effects of at least one of the plant stimulant component and the theacrine component. The theacrine containing component and the cannabis component can also be present in any suitable weight ratio or molar ratio to achieve such effects. Of course, the ratio may vary depending on the types of theacrine component and the cannabis component and the initial concentration of theacrine and CBD in those components, respectively. For example, where the plant stimulant component is a yerba mate leaf extract and the theacrine component is Teacrine®, and the cannabis component is a hemp oil concentrate, the weight ratio between the yerba mate leaf extract and the theacrine component can be between 4: 1 and 12: 1, preferably between 6: 1 and 10: 1, more preferably between 7: 1 and 9: 1, and most preferably around or about 8: 1. In this embodiment, the weight ratio between the theacrine component and the cannabis component can be between 0.1 :5 and 5:0.1, preferably between 0. 1 : 1 and 1 : 0.1, more preferably between 0.5 : 1 and 1 :05, more prefarbly between 0.8: 1.2 and 1.2:0.8 and most preferably around or about 1 : 1. The exemplary combinations of components in various ratios are shown in the examples of Table 1. Of course, it should be appreciated that the concentrations of the active ingredients within a given component (e.g., concentration of theacrine in the theacrine containing component) can vary and may therefore affect the ratios of the active components proportionally.

[0027] While the description herein is largely directed to the surprising benefits of combining a plant stimulant component, a theacrine containing component and a cannabis component, it should be appreciated that in some embodiments, the energy boosting energy compositions of the inventive subject matter can comprise additional active and inactive ingredients, including for example, a ginger component, a turmeric component, a vitamin B component, a green tea component, or any other suitable components. While these and other additional ingredients or components may be added for various purposes (e.g., stability, flavor, bioavailability, or other functional benefits, etc.), it is contemplated that the energy boosting effects can be provided solely by the specific and sometimes synergistic combinations of the plant stimulant component and the theacrine component in the noted quantities or relative proportions, and that the reduction in jitters caused by the plant stimulant component can be provided solely by the addition of the cannabis component.

[0028] With respect to the turmeric component, it is contemplated that the turmeric component can comprise at least one of turmeric, a turmeric extract, a curcumin, a desmethoxycurcumin, a bis-desmethoxy curcumin, a rosocyanine, and a curcumin

phosphatidylcholine complex and provide a beneficial effect (e.g., an anti -inflammatory effect). Preferably, the turmeric component comprises a curcumin phosphatidylcholine complex (e.g., Meriva®). It is contemplated the turmeric component can comprise (i) an individual turmeric component (e.g., curcumin phosphatidylcholine complex), or (ii) a combination of at least two of a turmeric, a turmeric extract, a curcumin, a

desmethoxycurcumin, a bis-desmethoxy curcumin, a rosocyanine, and a curcumin

phosphatidylcholine complex.

[0029] With respect to the ginger component, it is contemplated that the ginger component comprises at least one of a ginger, a ginger root extract, a shogaol, a zingerone, and a gingerol and provide a beneficial effect (e.g., an anti-inflammatory effect). Preferably, the ginger component comprises a ginger root extract (standardized to 5% gingerol). It is contemplated the ginger component can comprise (i) an individual ginger component (e.g., the ginger root extract), or (ii) a combination of at least two of a ginger, a ginger root extract, a shogaol, a zingerone, and a gingerol.

[0030] With respect to the green tea component, green tea leaf extracts containing green tea catechins are preferred, and can provide an antioxidative effect. The green tea leaf extract can comprise a strong infusion, a soft extract, a dry extract, a partly purified extract or any combination thereof. Additionally or alternatively, the green tea catechins found in green tea extracts (namely epicatechin (EC), epigallocatechin (EGC), epicatechin gallate (ECG) and epigallocatechin gallate (EGCG)) can be isolated and provided individually or in subcombinations.

[0031] In some contemplated formulations, two or more of the turmeric, ginger and green tea components are provided in a synergy blend that results in an anti-inflammatory, antioxidative or any other effects that can be quantitatively and qualitatively greater than the sum of the individuals. For example, the synergy blend (or its components) can make additional energy available to the person that would otherwise be needed to fight inflammation. The synergy blend can comprise any suitable wt% of the formulation's active or inactive ingredients, including for example, between l-25wt%, between 5-15wt%, and more preferably between 7-10wt%.

[0032] The inventors also contemplate that in order to help convert food into energy or create heightened alertness, focus, etc., a vitamin B component can be added to the composition to provide synergistic effect in boosting energy without adding any significant side effect. The vitamin B component can comprise at least one of methylcobalamin, cyanocobalamin, hydroxocobalamin, adenosylcobalamin, a vitamin B6, and biotin. In some contemplated aspects, the vitamin B component comprises a vitamin B12 from methylcobalamin.

[0033] It should be appreciated that each of the plant stimulant component, the theacrine containing component, the cannabis component, the turmeric component, the ginger component, the vitamin B component (e.g., vitamin B12, etc.) and the green tea component can comprise one or more ingredients (e.g., the ginger component include both ginger root extract and shogaol, etc.). Additionally or alternatively, each of the components can be present in the energy boosting formulation in any suitable ratio relative to one, some or all of the components. Additionally or alternatively, each of the vitamin B, ginger, green tea and turmeric components can be present in the formulation in any suitable ratio relative to the plant stimulant component, including for example. Additionally or alternatively, each of the vitamin B, ginger, green tea and turmeric components can be present in any suitable ratio relative to the theacrine containing component. Additionally or alternatively, each of the vitamin B, ginger, green tea and turmeric components can be present in any suitable ratio relative to the cannabis component.

[0034] In some contemplated formulations, the additional active or inactive ingredients (i.e., other than yerba mate leaf extract, Teacrine® and HempCHOICE®) will comprise no more than 20wt%, more preferably no more than 15wt% or 10wt% of the formulation. Viewed from a different perspective, the yerba mate leaf extract, Teacrine® and HempCHOICE can comprise at least 60wt%, at least 70wt%, at least 80wt%, or even 90wt% or more of the total weight of the formulation. While components of the inventive composition are preferably provided in a single composition comprising each of at least the plant stimulant, theacrine and cannabis components, it is also contemplated that the components can be administered sequentially individually or in groups. As the energy and mood enhancing effects with reduced jitters can be provided using only the plant stimulant, theacrine and cannabis components, some contemplated compositions can have a set of active ingredients consisting of or essentially consisting of the plant stimulant, theacrine and cannabis components.

Additionally, as the energy and mood enhancing effects with reduced jitters can be provided using only the plant stimulant, theacrine, cannabis, ginger, turmeric and green tea components, some contemplated compositions can have a set of active ingredients consisting of or essentially consisting of the plant stimulant, theacrine, cannabis, ginger, turmeric and green tea components.

[0035] Some exemplary oral compositions of the inventive subject matter are provided below in Table 1.

7 350-450 30-70 50-55 250-300 50-55 0 25-75 25-75

8 400 100 80-120 0 50 25-75 0 0

9 350-450 100 50-55 0 100 0 0 0

10 400 25 30-70 400 50 1-150 1-150 1-150

11 350-450 25 30-70 350-450 100 5-15 25-75 1-20

12 400 40-60 10-60 100-1000 0 0 0 0

13 350-450 40-60 80-100 350-450 0 1-50 1-50 1-50

14 250 40-60 15-35 250-500 0 5-35 5-35 5-35

Table 1

[0036] The quantities of each component can be modified to customize the energy boosting compositions to provide the level of a beneficial effect desired by the consumer. For example, quantities of the plant stimulant or the theacrine containing component may be disproportionately increased relative to the examples provided for the other components for a user having a high caffeine/stimulant tolerance. As another example, a quantity of the cannabis component may be disproportionately increased relative to the examples provided for the other components for a user having abnormally high anxiety levels. Therefore, it should be recognized that the amount of active ingredients in contemplated compositions can vary significantly. However, it is generally preferred that the active ingredients are present in a minimum amount effective to deliver the desired beneficial effects.

[0037] Contemplated compositions can be formulated to comprise any suitable amount of each of the various components, for example, in a single dose. For example, contemplated compositions can be formulated comprise between 100-600mg, between 200-450mg, or between 150-425mg of a yerba mate component per dosage unit. Additionally or

altematively, contemplated compositions can comprise between 5-200mg, between 5-100mg, or between 25-75mg of the theacrine containing component per dosage unit. Additionally or altematively, contemplated compositions can comprise between 5-200mg, between 5-100mg, or between 25-75mg of the cannabis component per dosage unit. Additionally or alternatively, contemplated compositions can comprise between 0-l,000mcg, between 100- 800mcg, or between 300-600mcg of the vitamin B component per dosage unit. Additionally or alternatively, contemplated compositions can comprise between 0-200mg, between 5- lOOmg, or between 25-75mg of the synergy blend per dosage unit. Additionally or alternatively, contemplated compositions can comprise between 0-lOOmg, between 5-75mg, or between 25-60mg of the green tea component per dosage unit. Additionally or

alternatively, contemplated compositions can comprise between 0-lOOmg, between 5-75mg, or between 25-60mg of the ginger component per dosage unit. Additionally or alternatively, contemplated compositions can comprise between 0-lOOmg, between 5-75mg, or between 25-60mg of the turmeric component per dosage unit. All combinations of all of the ranges provided herein are also contemplated.

[0038] Generally, contemplated compositions for energy boosting formulations include an amount of some or all of the components that is less than the amount found in known single active component supplements. For example, known single active component yerba mate supplements include 600 mg of yerba mate leaf extract and is suggested to be taken up to four times per day. In contrast, preferred compositions comprise a dose of the yerba mate component (e.g., yerba mate leaf extract, typically as concentrate between 1-20 %, preferably between 5-10 %, such as 8%) of about 400±50 mg suggested to be taken once or twice daily. It is contemplated that a dose of 400±50 mg of yerba mate present in a mixture with a dose of 50±20 mg of the theacrine component (and optionally 50±20 mg of the cannabis component) is effective to have the energy boosting effect of between 600-1800mg of yerba mate present in an oral formulation without the theacrine component. Such low doses of yerba mate-based ingredients are expected to increase tolerability and reduce the risk of adverse side effects associated with known yerba mate supplements.

[0039] The contemplated compositions can be formulated in any suitable carriers or forms for oral administration to the consumers. Especially preferred compositions are formulated in hard or soft gelcaps or tablets for oral administration. Additionally, the energy boosting compositions can be incorporated into medical foods. While yerba mate doses for capsules and tablets can typically be between about 200-450mg, it is contemplated that the doses for medical food preparations may be significantly higher and include 600-2,500mg, 2,000- 4,000mg, 3,000-7,000mg, 7,000-10,000mg, and even higher. Customized doses of the energy boosting compositions can be formulated and provided to meet an individual's specific needs. Contemplated doses include both low (e.g., about 100-200mg, about 200- 300mg) and higher doses.

[0040] In some embodiments, the compositions can be formulated as an energy drink.

Preferably, such energy drink includes sugar or other carbohydrates in less than 20%, preferably less than 10%, more preferably less than 5% weight/volume of the drink, and/or less than 20%, preferably less than 10%, more preferably less than 5% of the daily dietary recommended or maximum amount (e.g., 37.5 g for men, and 25 g for women, etc.). It is also contemplated that some flavor can be added to make the energy drink more palatable, for example, by adding coconut juice, coconut concentrate, fruit flavors, coffee flavors, and so on. Alternatively, the liquid base may also be a fruit juice, coconut water, coffee, or tea. Most typically, the overall dosages of contemplated ingredients will be the same as indicated above, and may be present in or delivered to the energy drink as a mix-in (e.g., from a separate compartment where stability or appearance issues are encountered).

[0041] The administration of the suitable dose can be administered once per day, or can be spread out over the course of a day. For example, an effective dose of the composition can be divided and separately packaged as two to five capsules, tablets, powders, oral dissolve strips, syrups, suspensions, wafers, and separately administered two to five times a day.

[0042] The pharmaceutical preparations can be made following the conventional techniques of pharmacy involving milling, mixing, granulation, and compressing, when necessary, for tablet forms; or milling, mixing and filling for hard gelatin capsule forms. When the dosage unit form is a capsule, it may additionally contain a pharmaceutically acceptable carrier, such as a liquid carrier (e.g., a fatty oil). Other dosage unit forms may contain other various materials which modify the physical form of the dosage unit, such as, for example, a coating. Thus, tablets or pills may be coated with sugar, shellac, or other enteric coating agents. Such capsules or tablets may contain a controlled-release formulation as may be provided in a dispersion of active compound in hydroxypropylmethyl cellulose.

[0043] Materials used in preparing these various compositions are preferred to be

pharmaceutically or veterinarally pure and non-toxic in the amounts used. "Pharmaceutically acceptable carrier" as used herein refers to a pharmaceutically acceptable material, composition, or vehicle that is involved in carrying or transporting a compound of interest from one tissue, organ, or portion of the body to another tissue, organ, or portion of the body. For example, the carrier may be a liquid or solid filler, diluent, excipient, solvent, or encapsulating material, or a combination thereof. Each component of the carrier must be "pharmaceutically acceptable" in that it must be compatible with the other ingredients of the formulation.

[0044] Although the description herein is generally directed to oral dosage forms (e.g., capsules, powders, tablets, troches, elixirs, suspensions, syrups, wafers, chewing gums, aqueous suspensions or solutions), the compositions according to the inventive subject matter may be administered using various routes. For example, contemplated compositions can be administered topically via a transdermal patch, cream or ointment, possibly with penetration enhancers and administered to skin over the carotid artery.

[0045] The inventors contemplate that the compositions described above modify an activity of a plant stimulant component, especially yerba mate component independently. The amount of theacrine containing component mixed with the yerba mate component is contemplated to enhance an energy improving (or other beneficial) effect of the yerba mate plant component or provide synergistic effect (i.e., increase of the energy improvement effect more than the sum of individual effect of each component, at least 5%, at least 10%, at least 20% more, etc.). Additionally or alternatively, a negative effect of yerba mate component or theacrine component, or both, can be minimized or reduced by adding a cannabis component in an effective amount. It should be appreciated that such increasing positive effect and decreasing negative effect without compromising each other such that the positive effect is increased with addition of theacrine component, and not significantly decreased by addition of cannabinoid component.

[0046] In some embodiments, the level of the positive effect and the level of the undesired or negative effect can be measured or at least estimated using various methods, including, but not limited to a visual analog scale, questionnaires, and observations. Table 2 provides one exemplary test results of an individual measuring the positive effect and the negative effect by questionnaires. The individual was provided with 1) yerba mate component only, 2) yerba mate component + theacrine component, 3) yerba mate component + cannabinoid component, 4) yerba mate component + theacrine component + cannabinoid component, and 5) a control, placebo component (nonactive substances only). As shown in Table 2, theacrine component could increase the alertness level of the individual independently to the addition of cannabinoid component, and the cannabinoid component could increase the calming effect (less jitteriness) significantly without reducing the positive effect of theacrine component and yerba mate component.

Table 2

[0047] Generally, many stimulants including prescribed drugs such as Adderall , Ephedrine, Desoxyn, or some prohibited substances such as cocaine or methamphetamine, induces dopamine secretion in the brain that results in some "positive" effect including euphoria, wakefulness, and energy. Those "positive" effects often follow with negative effects including jitteriness, nervousness, which motivates consumers to take more stimulants to avoid or get out of the negative effects and eventually leads the consumers to be addicted to the stimulants. Thus, the inventors further contemplate that the compositions described above, with increased positive effect (e.g., alertness) and decreased negative or undesired effect (e.g., jitteriness), can be used to treat a stimulant-addicted person or reducing the stimulant-addiction in a person. For example, a dose of the compositions can be provided or administered to a stimulant-addicted person to consume instead of the stimulants (prescribed or non-prescribed), in a schedule effective to reduce the addiction to the stimulant substance (e.g., less craving for the stimulant substances, maintaining emotional and mental stability without the stimulant substance, etc.). As used herein, the term "administering" refers to both direct and indirect administration, wherein direct administration is typically performed by a health care professional (e.g., physician, nurse, etc.), and wherein indirect administration includes a step of providing or making available the composition to the health care professional for direct administration (e.g., via injection, oral administration, dermal patch, etc.).

[0048] As used in the description herein and throughout the claims that follow, the meaning of "a," "an," and "the" includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of "in" includes "in" and "on" unless the context clearly dictates otherwise. The discussion provides example embodiments of the inventive subject matter. Although each embodiment represents a single combination of inventive elements, the inventive subject matter is considered to include all possible combinations of the disclosed elements. Thus if one embodiment comprises elements A, B, and C, and a second embodiment comprises elements B and D, then the inventive subject matter is also considered to include other remaining combinations of A, B, C, or D, even if not explicitly disclosed.

[0049] In some embodiments, the numbers expressing quantities of ingredients, properties such as concentration, reaction conditions, and so forth, used to describe and claim certain embodiments of the invention are to be understood as being modified in some instances by the term "about." Accordingly, in some embodiments, the numerical parameters set forth in the written description and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by a particular embodiment. In some embodiments, the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as practicable. The numerical values presented in some

embodiments of the invention may contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements. Moreover, and unless the context dictates the contrary, all ranges set forth herein should be interpreted as being inclusive of their endpoints and open-ended ranges should be interpreted to include only commercially practical values. Similarly, all lists of values should be considered as inclusive of intermediate values unless the context indicates the contrary.

[0050] It should be apparent, however, to those skilled in the art that many more

modifications besides those already described are possible without departing from the inventive concepts herein. The inventive subject matter, therefore, is not to be restricted except in the spirit of the disclosure. Moreover, in interpreting the disclosure all terms should be interpreted in the broadest possible manner consistent with the context. In particular the terms "comprises" and "comprising" should be interpreted as referring to the elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps can be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced.

Claims

What is claimed is:

1. An oral composition, comprising:

a plant stimulant component;

a theacrine containing component;

a cannabis component;

wherein the theacrine containing component is present in an amount sufficient to enhance a first effect of the plant stimu lant component; and

wherein the cannabis component is present in an amount effective to reduce a second effect of the plant stimulant component.

2. The oral composition of claim 1 , wherein the plant stimulant component comprises a verba mate leaf extract.

3. The oral composition of any of claims 1-2, wherein the cannabis component comprises a cannabidiol hemp oil.

4. The oral composition of claim 3, wherein the cannabidiol hemp oil is a concentrate and obtained from a high-CBD and low-THC hemp plant.

5. The oral composition of claim 3, wherein the cannabidiol hemp oil is processed to remove THC.

6. The oral composition of any of claims 1-5, wherein the theacrine containing component is obtained from Camellia Kucha tea leaves, and wherein the theacrine component is further present in an amount sufficient to prolong the first effect.

7. The oral composition of claim 6, wherein the theacrine containing component comprises an extract.

8. The oral composition of any of claims 1 -7, wherein the first effect comprises at least one of energy enhancement, mood enhancement and appetite suppression.

9. The oral composition of any of claims 1-8, wherein the second effect is at least one of jitters, nervousness, anxiety, tension and agitation.

10. The oral composition of any of claims 1 -9, further comprising a ginger com ponent.

1 1 . The oral composition of claim 10, wherein the ginger component comprises at least one of a ginger, a ginger root extract, a shogaol, a zingerone, and a gingerol.

12. The oral composition of any of claims 1-1 1 , further comprising a turmeric component.

13. The oral composition of claim 12, wherein the turmeric component comprises at least one of a turmeric, a turmeric extract, a curcumin phytosome, a desmethoxycurcumin, a bis- desmethoxycurciimin, a rosocyanine, and a curcumin phosphatidylcholine complex.

1 4. The oral composition of any of claims 1 -13, further comprising a vitamin B component.

1 5. The oral composition of claim 14, wherein the vitamin B component comprises methyicobalamin or cyanocobalamin.

1 6. The oral composition of any of c laims 1 -15, wherein at least two components are present in synergistic amounts with respect to at least one of the first and second effects.

17. The oral composition of any of claims 1 -16, wherein the plant stimulant component and the cannabis component are present at a weight ratio of between 6: 1 and 1.0:1 , inclusive.

18. The oral composition of any of claims 1 -17, wherein the theacrine containing component and the cannabis component are present at a weight ratio of between 0.5: 1 and 1 :0.5, inclusive.

19. A method of modifying an activity of a yerba mate component containing mixture for an oral composition, comprising:

adding a theacrine containing component to the mixture in an amount effective to enhance an energy improving effect of the yerba mate plant component.

20. The method of claim 1 , further comprising adding a cannabis component to the mixture in an amount effective to reduce a negative effect of the yerba mate plant component.

21. The method of any of claims 19-20, wherein the yerba mate component comprises a yerba mate leaf extract.

22. The method of any of claims 20-21 , wherein the cannabis component comprises a cannabidiol hemp oil.

23. The method of claim 22, wherein the cannabidiol hemp oil is a concentrate and obtained from a high-CBD and low-THC hemp plant.

24. The method of any of claims 22-23, wherein the cannabidiol hemp oil is processed to remove THC.

25. The method of any of claims 20-24, wherein the theacrine containing component is obtained from Camellia Kucha tea leaves, and wherein the theacrine component is present in an amount effective to synergistically enhance the energy improving effect.

26. The method of claim 25, wherein the theacrine containing component comprises an extract.

27. The method of any of claims 20-26, wherein the negative effect is at least one j itters, nervousness, anxiety, tension and agitation.

28. The method of any of claims 20-27, wherein the mixture further comprises a ginger component.

29. The method of claim 28, wherein the ginger component comprises at least one of a ginger, a ginger root extract, a shogaol, a zingerone, and a gingerol.

30. The method of any of claims 20-29, wherein the mixture further comprises a turmeric component.

31 . The method of claim 30, wherein the turmeric component comprises at least one of a turmeric, a turmeric extract, a curcumin phytosome, a desmethoxycurcumin, a bis- desmethoxycurcumin, a rosocyanine, and a curcumin phosphatidylcholine complex.

32. The method of any of claims 20-31 , wherein the mixture further coniprises a vitamin B component.

33. The method of claim 32, wherein the vitamin B component comprises methylcobalamin or cyanocobalaniin.

34. The method of any of claims 20-33, wherein the verba mate component and the cannabis component are present in the mixture at a weight ratio of between 6: 1 and 10: 1 , inclusive.

35. The method of any of claims 20-34, wherein the theacrine containing component and the cannabis component are present in the mixture at a weight ratio of between 0.5: 1 and 1 :0.5, inclusive.

36. A method of modifying an activity of a mixture for an oral composition, wherein the mixture includes a yerba mate component and a theacrine containing component, and wherein the theacrine containing component is present in an amount sufficient to enhance an energy improving effect of the yerba mate component, the method comprising:

adding a cannabis component to the mixture in an amount effective to reduce a negative effect of a combination of the theacrine containing component and the yerba mate component present in the mixture.

37. The method of claim 36, wherein the yerba mate component comprises a yerba mate leaf extract.

38. The method of any of claims 36-37, wherein the cannabis component comprises a cannabidiol hemp oil.

39. The method of claim 38, wherein the cannabidiol hemp oil is a concentrate and obtained from a high-CBD and low-THC hemp plant.

40. The method of claim 39, wherein the cannabidiol hemp oil is processed to remove THC.

41. The method of any of claims 36-40, wherein the theacrine containing component is obtained from Camellia Kucha tea leaves, and wherein the theacrine component is present in an amount effective to synergistically enhance the energy improving effect.

42. The method of any of claims 36-41, wherein the theacrine containing component comprises an extract.

43. The method of any of claims 36-42, wherein the negative effect is at least one jitters, nervousness, anxiety, tension and agitation.

44. The method of any of claims 36-43, wherein the mixture further comprises a ginger component.

45. The method of claim 44, wherein the ginger component comprises at least one of a ginger, a ginger root extract, a shogaol, a zingerone, and a gingerol.

46. The method of any of claims 36-45, wherein the mixture further comprises a turmeric component.

47. The method of claim 46, wherein the turmeric component comprises at least one of a turmeric, a turmeric extract, a curcumin p!iytosome, a desmethoxycurcumin, a bis- desmethoxycurcumin, a rosocyanine, and a curcumin phosphatidylcholine complex.

48. The method of any of claims 36-47, wherein the mixture further comprises a vitamin B component.

49. The method of claim 48, wherein the vitamin B component comprises methylcobalamin or cyanocoba!amin.

50. The method of any of claims 36-49, wherein the verba mate component and the cannabis component are present in the mixture at a weight ratio of between 6;] and 10:1 , inclusive.

51 . The method of any of claims 36-50, wherein the theacrine containing component and the cannabis component are present in the mixture at a weight ratio of between 0.5: 1 and 1 :0.5. inclusive.

52. A method of enhancing an energy level in a person, comprising:

formulating or obtaining an oral composition comprising a plant stimulant

component, a theacrine containing component, and a cannabis component; wherein the theacrine containing component is present in an amount effective to modify an energy increasing capability of the plant stimulant component, and wherein the cannabis component is present in an amount effective to reduce a negative side effect of at least one of the plant stimulant component and the theacrine containing component; and

administering to the person a dose of the oral composition effective to enhance the energy level of the person.

53. The method of claim 52, wherein the oral composition further comprises a vitamin B12 component, a turmeric component and a ginger root component, and wherein the plant stimulant component comprises yerba mate extract, and wherein the cannabis component comprises a hemp oil concentrate.

54. The method of any of claims 52-53, wherein the negative side effect comprises at least One of jitters, nervousness and anxiety.

55. A method of minimizing a negative effect of a nvixlure for an oral composition including a plant stimulant component and a theacrine containing component, comprising:

adding a cannabis component to the mixture in an amount effective to reduce the negative effect of the mixture when administered via the oral composition.

56. The method of claim 55, wherein the plant stimulant component comprises a yerba mate leaf extract.

57. The method of any of claims 55-56, wherein the cannabis component comprises a cannabidiol hemp oil.

58. The method of claim 57, wherein the cannabidiol hemp oil is a concentrate and obtained from a high-CBD and low-THC hemp plant.

59. The method of claim 57, wherein the cannabidiol hemp oil is processed to remove THC.

60. The method of any of claims 55-59, wherein the theacrine containing component is obtained from Camellia Kucha tea leaves, and wherein the theacrine component is present in an amount effective to enhance a first effect of the plant stimulant component.

61.. The method of any of claims 55-60, wherein the theacrine containing component comprises a powder.

62. The method of any of claims 55-61 , wherein the negative effect is at least one jitters, nervousness, anxiety, tension and agitation.

63. The method of any of claims 55-62, wherein the mixture further comprises a ginger component.

64. The method of claim 63, wherein the ginger component comprises at least one of a ginger, a ginger root extract, a shogaol, a zingerone, and a gingerol.

65. The method of any of claims 55-64, wherein the mixture further comprises a turmeric component.

66. The method of claim 65, wherein the turmeric component comprises at least one of a turmeric, a turmeric extract, a curcumin phytosome, a desmethoxycurcumin, a bis- desmethoxycurcumin, a rosocyaiiine, and a curcumin phosphatidylcholine complex.

67. The method of any of claims 55-66, wherein the mixture further comprises a vitamin B component.

68. The method of claim 67, wherein the vitamin B component comprises methylcobalamin or cyanocobalamin.

69. The method of any of claims 55-68, wherein the plant stimulant component and the cannabis component are present in the mixture at a weight ratio of between 6:1 and 10: 1 , inclusive.

70. The method of any of claims 55-69, wherein the theacrine containing component and the cannabis component are present in the mixture at a weight ratio of between 0.5: 1 and 1 :0.5, inclusive.

71. An oral composition, comprising:

a yerba mate component:

a Camellia Kucha component;

a cannabidiol fraction;

wherein the Camellia Kucha containing component is present in an amount sufficient to enhance a first effect of the yerba mate component; and

wherein the cannabidiol fraction is present in an amount effective to reduce a second effect of the yerba mate component.

72. The oral composition of claim 71, further comprising at least one of a green tea component, a ginger root component, a curcumin component, and a vitamin B component.

73. The oral composition of claim 71 , further comprising at least two of a green tea component, a ginger root component, a curcumin component, and a vitamin B component.

74. The oral composition of claim 71 , further comprising at least three of a green tea component, a ginger root component, a curcumin component, and a vitamin B component.

75. The oral composition of claim 71, further comprising a green tea component, a ginger root component, a curcumin component, and a vitamin B component,

76. The oral composition of any of claims 71-75, wherein the yerba mate component is a yerba mate leaf extract with between 1 5-25% caffeine content.

77. The ora l composition of any of claims 71 -76, wherein the Camellia Kucha component comprises Teacrine.

78. The oral composition of any of claims 71 -77, wherein the cannabidiol fraction comprises a hemp oil concentrate having less than 3% of THC.

79. An oral composition, comprising:

a stimulant composition consisting essentially of:

a plant stimulant component;

a theacrine containing component; and

a cannabis component;

wherein the theacrine containing component is present in an amount sufficient to enhance a first effect of the plant stimulant component; and

80. The oral composition of claim 79, wherein the plant stimulant component comprises a yerba mate leaf extract.

81 . The oral composition of any of claims 79-80, wherein the cannabis component comprises a cannabidiol hemp oil.

82. The oral composition of claim 81 , wherein the cannabidiol hemp oil is a concentrate and obtained from a high-CBD and low-THC hemp plant.

83. The oral composition of claim 81 , wherein the cannabidiol hemp oil is processed to remove THC.

84. The oral composition of any of claims 79-83, wherein the theacrine containing component is obtained from Camellia Kucha tea leaves, and wherein the theacrine component is further present in an amount sufficient to prolong the first effect.

85. The oral composition of claim 84, wherein the tiieacrine containing component comprises an extract.

86. The oral composition of any of claims 79-85, wherein the first effect comprises at least one of energy enhancement, mood enhancement and appetite suppression.

87. The oral composition of any of claims 79-86, wherein the second effect is at least one of jitters, nervousness, anxiety, tension and agitation.

88. The oral composition of any of claims 79-87, further comprising a ginger component.

89. The oral composition of claim 88, wherein the ginger component comprises at least one of a ginger, a ginger root extract, a shogaol, a zingerone, and a gingerol.

90. The oral composition of any of claims 79-89, further comprising a turmeric component.

9 . The oral composition of claim 90, wherein the turmeric component comprises at least one of a turmeric, a turmeric extract, a curcumin phytosome, a desmethoxycurcumin, a bis- desmethoxycurcuniin, a rosocyanine, and a curcumin phosphatidylcholine complex.

92. The oral composition of any of claims 79-91, further comprising a vitamin B component.

93. The oral composition of claim 92, wherein the vitamin B component comprises methylcobalamin or cyanocobalamin.

94. The oral composition of any of claims 79-93, wherein at least two components are present in synergistic amounts with respect to at least one of the first and second effects.

95. The oral composition of any of claims 79-94, wherein the plant stimulant component and the cannabis component are present at a weight ratio of between 6: 1 and 10: 1 , inclusive.

96. The oral composition of any of claims 79-95, wherein the tiieacrine containing component and the cannabis component are present at a weight ratio of between 0.5: 1 and 1 :0.5, inclusive. of the composition of claims 1 -18, 71 -78, or 79-96 for treating a stimulant-addicted

98. U se of the composition of claims 1 -18, 71.-78, or 79-96 for reducing stimulant-add iction in a person.