US20170119836A1 - Method of making a liquid composition - Google Patents

Method of making a liquid composition Download PDF

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Publication number
US20170119836A1
US20170119836A1 US15/287,149 US201615287149A US2017119836A1 US 20170119836 A1 US20170119836 A1 US 20170119836A1 US 201615287149 A US201615287149 A US 201615287149A US 2017119836 A1 US2017119836 A1 US 2017119836A1
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United States
Prior art keywords
vitamin
acetyl
solution
dissolving
bitartrate
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Abandoned
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US15/287,149
Inventor
Patricia Gutierrez
Christina Beer
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Braingear Enterprises Inc
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Braingear Enterprises Inc
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Publication date
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Priority to US15/287,149 priority Critical patent/US20170119836A1/en
Assigned to Braingear Enterprises, Inc. reassignment Braingear Enterprises, Inc. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: BEER, CHRISTINA, GUTIERREZ, PATRICIA
Publication of US20170119836A1 publication Critical patent/US20170119836A1/en
Abandoned legal-status Critical Current

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    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • A—HUMAN NECESSITIES
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    • A23L2/00—Non-alcoholic beverages; Dry compositions or concentrates therefor; Their preparation
    • A23L2/52—Adding ingredients
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    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L2/00—Non-alcoholic beverages; Dry compositions or concentrates therefor; Their preparation
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Definitions

  • the present disclosure relates to methods of making a liquid composition which, in some embodiments can be used to improve human health, in particular, human brain health.
  • the liquid composition is intended to improve focus, clarity, concentration, mental performance and overall well-being.
  • the liquid composition is intended to support brain health, especially six key areas to brain health: neurotransmission support, axon regeneration, BACE1 metabolism/inhibition, tau-protein metabolism/inhibition, mitochondrial function, and antioxidant protection.
  • the liquid composition is intended to support long-term memory, cognitive support, promote mood stability, restful sleep and improved nerve cell-integrity.
  • methods of making a liquid dietary supplement composition comprise preparing a solution by dissolving L-Theanine in water; and subsequently dissolving Acetyl L-Carnitine, Choline Bitartrate, Inositol, N-Acetyl L-Tyrosine and PQQ in the solution.
  • DMAE Bitartrate is dissolved in the solution.
  • Acetyl L-Carnitine, Choline Bitartrate, Inositol, N-Acetyl L-Tyrosine and PQQ are added to the solution in the form of a single premix.
  • Vitamin D, Niacin, Vitamin B6, and Vitamin B12 are added to the solution.
  • the methods additionally comprise dissolving Green Tea Extract in the solution.
  • the methods additionally comprise dissolving Vitamin E in the solution.
  • the methods additionally comprise dissolving one or more flavoring components in the solution.
  • the flavoring components comprise one or more of natural flavors and/or natural sweeteners.
  • a composition produced by the methods comprises 0.0001-800 mg of L-Theanine; 0.0001-5,000 IU of Vitamin D; 0.0001-200 mg of Niacin; 0.0001-30 mg of Vitamin B6; 0.0001-3 mg of Vitamin B12; 0.0001-30 mg of PQQ; 0.0001-2 g of Acetyl-L-Carnitine; 0.0001-1 g of Choline bitartrate; 0.0001-1 g of Inositol; 0.0001-1 g of N-Acetyl L-tyrosine; 0.0001-250 mg DMAE bitartrate; 0.0001-300 mg of Green Tea extract; and 0.0001-400 IU of Vitamin E.
  • a serving of the composition comprises 0.0001 to 2 g of Acetyl-L-carnitine; 0.0001 to 1 g of Choline bitartrate; 0.0001 to 1 g of Inositol; 0.0001 to 1 g of N-Acetyl L-tyrosine; 0.0001 to 800 mg of L-Theanine; and 0.0001 to 30 mg of PQQ in a volume of 2 fl. oz. to 54 fl. oz. In some embodiments the serving is 4.5 fl. oz.
  • a liquid composition is prepared by forming a solution of L-theanine in water and subsequently adding Pyrroloquinoline Quinone (PQQ), Acetyl-L-Carnitine, Choline bitartrate, Inositol, N-Acetyl L-Tyrosine, DMAE bitartrate, Vitamin D, Niacin, Vitamin B6, Vitamin B12, Green Tea extract and Vitamin E to the solution.
  • PQQ Pyrroloquinoline Quinone
  • Acetyl-L-Carnitine Acetyl-L-Carnitine
  • Choline bitartrate Choline bitartrate
  • Inositol N-Acetyl L-Tyrosine
  • DMAE bitartrate Vitamin D, Niacin, Vitamin B6, Vitamin B12, Green Tea extract and Vitamin E
  • One or more flavoring components can be subsequently added to the solution.
  • a volume of 2 fl. oz to 54 fl. oz. of the solution comprises: 0.0001 to about 800 mg of L-Theanine; 0.0001 to about 30 mg of PQQ; 0.0001 to about 2 g of Acetyl-L-Carnitine; 0.0001 to about 1 g of Choline bitartrate; 0.0001 to about 1 g of Inositol; 0.0001 to about 1 g of N-Acetyl L-Tyrosine; 0.0001 to about 250 mg of DMAE bitartrate; 0.0001 to 5,000 IU of Vitamin D; 0.0001 to 200 mg of Niacin; 0.0001 to 30 mg of Vitamin B6; 0.0001 to 3 mg of Vitamin B12; 0.0001 to about 300 mg of Green Tea; and 0.0001 to about 400 IU of Vitamin E.
  • the volume is 4.5 fl. oz.
  • liquid dietary supplements are pH dependent and if not added in the correct order can form a sediment and/or precipitate, resulting in particles floating on top of or dispersed in the liquid. In many cases, this is undesirable in the liquid product.
  • a liquid dietary supplement such as a liquid dietary supplement for brain health
  • methods for making a liquid dietary supplement composition are described, where the liquid dietary supplement comprises one or more ingredients that are prone to floatation, sedimentation or precipitation.
  • methods of making a liquid dietary supplement drink using a combination of synergistic ingredients that target long and short-term human brain health are described in which the formation of floaties (precipitate) or bottom-settlement (sediment) in the composition is reduced or avoided entirely.
  • the generation of a sediment and/or precipitate can be reduced or avoided by combining the ingredients in one or more particular sequences.
  • special attention is given to the order in which each ingredient is added.
  • the ingredients are added in an order which results in all of the ingredients going into solution, or staying in suspension.
  • indicators of stability of the composition can be preserved during preparation of the liquid composition.
  • indicators of stability of the composition may include, for example, flavor profile, texture and mouth-feel.
  • one or more indicator of stability, such as flavor profile, texture and mouth-feel of the composition prepared according to the methods described herein are substantially as desired.
  • the composition comprises Inositol, N-Acetyl L-Tyrosine, pyrroloquinoline quinone (PQQ), Acetyl-L-Carnitine and Choline bitartrate and L-Theanine as active ingredients.
  • the composition additionally comprises Dimethylaminoethyl (DMAE) bitartrate.
  • composition may comprise one or more of Vitamin E, Vitamin D, Niacin, Vitamin B6, Vitamin B 12, and Green Tea extract.
  • the composition comprises Acetyl L-Carnitine, Choline bitartrate, Inositol, N-Acetyl L-Tyrosine, L-Theanine and pyrroloquinoline quinone (PQQ), as well as one or more of Dimethylaminoethyl (DMAE) bitartrate, Vitamin E, Vitamin D, Niacin, Vitamin B6, Vitamin B12, and Green Tea extract as active ingredients.
  • DMAE Dimethylaminoethyl
  • the composition comprises Inositol, N-Acetyl L-Tyrosine, Dimethylaminoethyl (DMAE) bitartrate, pyrroloquinoline quinone (PQQ), Acetyl-L-Carnitine, Choline bitartrate, L-Theanine and one or more of Vitamin E, Vitamin D, Niacin, Vitamin B6, Vitamin B 12, L-Theanine and Green Tea extract as active ingredients.
  • DMAE Dimethylaminoethyl
  • PQQ pyrroloquinoline quinone
  • Acetyl-L-Carnitine Acetyl-L-Carnitine
  • Choline bitartrate L-Theanine
  • one or more of Vitamin E Vitamin D, Niacin, Vitamin B6, Vitamin B 12, L-Theanine and Green Tea extract as active ingredients.
  • the composition comprises at least Inositol, N-Acetyl L-Tyrosine, Dimethylaminoethyl (DMAE) bitartrate, pyrroloquinoline quinone (PQQ), Acetyl-L-Carnitine, Choline bitartrate, Vitamin E, Vitamin D, Niacin, Vitamin B6, Vitamin B 12, L-Theanine and Green Tea extract as active ingredients.
  • DMAE Dimethylaminoethyl
  • PQQ pyrroloquinoline quinone
  • the composition may comprise one or more additional active ingredients such as alpha-GPC (alpha-glycerylphosphorylcholine), Citicholine, Phosphatidylserine, Astaxanthin, Flaxseed, MCT (Medium Chain Triglycerides), Whole Coffee Fruit extract, Ginko biloba , Vinpocetine, Panax ginseng , Ashwaghanda, Bacopa monnieri , Grape seed extract, dark skinned berries and fruits known for their high concentrations of polyphenols/anthocyanidins, omega-3 fatty acids, omega-6 fatty acids, omega-9 fatty acids, Huperzine A, alpha-Lipoic acid., Magnesium and Zinc.
  • additional active ingredients such as alpha-GPC (alpha-glycerylphosphorylcholine), Citicholine, Phosphatidylserine, Astaxanthin, Flaxseed, MCT (Medium Chain Triglycerides), Whole Coffee Fruit extract, Ginko bilob
  • L-Theanine is the first ingredient added to water or other liquid in preparing a liquid composition. Flavor components, colorants and sweeteners, if any, are typically added last. The remaining ingredients may be added in any order or combination. However, as discussed below in some embodiments additional ingredients are added in a specific order.
  • the composition is provided in the form of a liquid drink.
  • the liquid drink may comprise the active ingredients in a water base, or in another base liquid that is inert with respect to the active ingredients.
  • the liquid drink may comprise one or more additional inactive ingredients.
  • the liquid drink may comprise one or more preservatives such as citrus oil, sorbates and benzoates.
  • the liquid drink may also comprise one or more flavors such as fruit (e.g. strawberry, melon, etc.) and non-fruit flavors.
  • the flavor is a natural flavor.
  • the composition such as a liquid drink, may comprise a sweetener, such as sucralose or acesulfame K or a combination of these.
  • a sweetener such as sucralose or acesulfame K or a combination of these.
  • the sweetener is a natural sweetener such as sugar, fructose, honey, agave, monk fruit, stevia, erythritol, xylitol, citrus and protein extracts or a combination of these.
  • a liquid composition is prepared by adding L-Theanine to a liquid to form a solution. Additional ingredients are subsequently added. The additional ingredients may be added singly or in combination. However, the quantity and order of addition of the additional ingredients is selected such that each additional ingredient goes into solution in the liquid.
  • a liquid composition is prepared by combining the following components:
  • the water and L-Theanine are combined first to form a solution and the remaining ingredients are added subsequently, either singly or in combination.
  • DMAE bitartrate is added to the liquid composition. In some embodiments DMAE is added simultaneously with or subsequent to one or more of the first seven ingredients. In some embodiments DMAE is added after the first seven ingredients as listed above.
  • a liquid composition is prepared by combining the following components:
  • flavor components and sweeteners may be added.
  • the water and L-Theanine are combined first to form a solution and the remaining ingredients are added subsequently, either singly or in combination.
  • the first 12 ingredients are combined prior to subsequent addition of the Green Tea Extract and Vitamin E, in that order.
  • a liquid composition is prepared by combining the following components in the order provided below:
  • DMAE bitartrate is subsequently added after the N-Acetyl L-Tyrosine.
  • flavoring agents, sweeteners and/or preservatives are optionally added after the listed ingredients.
  • a liquid composition is prepared by combining the following components in the order provided below:
  • one or more of the 16 listed components may be omitted; however, the remaining components are added in the specified order.
  • a liquid composition is formed by initially combining a L-Theanine and water or other liquid.
  • L-Theanine is added in an amount sufficient to achieve the desired concentration of L-Theanine in the liquid drink composition.
  • L-Theanine is preferably added to the water prior to any other ingredients in order to allow for optimum solubility throughout the liquid phase. If L-Theanine is not added as the first ingredient, added as the last ingredient and/or added as part of a premix comprising other ingredients, the L-theanine may not completely dissolve in the water. This can interfere with the dispersion and solubility of other ingredients throughout the liquid phase and may, for example, lead to clumps (precipitation) and/or fall-out (sedimentation) throughout the liquid. Thus, L-Theanine is the first ingredient added in some embodiments.
  • the other ingredients are added to a solubilized L-theanine in water individually and sequentially in any order.
  • the other ingredients are added to a solubilized L-theanine in water individually in a specified order, such as in the specific embodiments discussed above.
  • one or more additional ingredients are added to the L-Theanine and water solution as one or more premixes, each comprising a fraction of the other ingredients.
  • the premixes may be added in multiple steps or in a single step.
  • all additional ingredients are added to the L-Theanine and water solution as a single premix comprising all the additional ingredients.
  • Inositol, N-Acetyl L-Tyrosine, Pyrroloquinoline Quinone (PQQ), Acetyl-L-Carnitine and Choline bitartrate are dissolved in an L-Theanine and water solution, either sequentially or as a premix containing some or all of the components.
  • Inositol, N-Acetyl L-Tyrosine, Pyrroloquinoline Quinone (PQQ), Acetyl-L-Carnitine, Choline bitartrate and Dimethylaminoethyl (DMAE) bitartrate are dissolved in an L-Theanine and water solution, either sequentially or as a premix containing some or all of the components.
  • Inositol, N-Acetyl L-Tyrosine, Dimethylaminoethyl (DMAE) bitartrate, Pyrroloquinoline Quinone (PQQ), Acetyl-L-Carnitine, Choline bitartrate, Vitamin E, Vitamin D, Niacin, Vitamin B6, Vitamin B12, and Green Tea extract are dissolved in a solution of L-Theanine and water, either individually or as a premix containing two or more of the components. In some embodiments Green Tea extract and Vitamin E are added last.
  • Acetyl-L-Carnitine, Choline bitartrate, Inositol, N-Acetyl L-Tyrosine, PQQ are added individually and sequentially to the L-Theanine and water solution. In some embodiments, Acetyl-L-Carnitine, Choline bitartrate, Inositol, N-Acetyl L-Tyrosine, and PQQ are added to the L-Theanine and water solution as a single premix comprising all the ingredients.
  • the time required for dissolving the additional components in the L-Theanine and water solution is at least about 10 to about 60 minutes. In some embodiments, the time required is about 10 to about 20 minutes. In some embodiments, the time required is about 20 to about 60 minutes.
  • Acetyl-L-Carnitine, Choline bitartrate, Inositol, N-Acetyl L-Tyrosine, and PQQ are dissolved in the solution of water and L-Theanine, for example by one or more of the following techniques: gentle stirring, gentle vortexing, and gentle heating.
  • the time required for dissolving these components is at least about 5 to about 60 minutes. In some embodiments, the time required is about 5 to about 10 minutes. In some embodiments, the time required is about 10 to about 60 minutes.
  • one or more additional ingredients such as Dimethylaminoethyl (DMAE) bitartrate, Vitamin E, Vitamin D, Niacin, Vitamin B6, Vitamin B12, and Green Tea extract are dissolved in the solution, for example by one or more of the following techniques: gentle stirring, gentle vortexing, gentle heating.
  • DMAE Dimethylaminoethyl
  • Vitamin E Vitamin D
  • Niacin Vitamin B6, Vitamin B12, and Green Tea extract
  • the time required for dissolving these components is at least about 5 to about 60 minutes. In some embodiments, the time required is about 5 min.
  • Flavoring components can also be added to the solution.
  • any and all flavoring components, such as Natural flavors, and sweeteners are added next individually and sequentially in any order.
  • the order of addition is Natural flavors, and sweetener system.
  • the flavoring components may be dissolved in the solution, for example by one or more of the following techniques: gentle stirring, gentle vortexing, gentle heating.
  • the time required for dissolving these components is at least about 5 to about 60 minutes. In some embodiments, the time required is about 5 to about 10 minutes. In some embodiments, the time required is about 10 to about 60 minutes.
  • the flavoring components comprise Natural flavors, and one or more sweeteners.
  • exemplary sweeteners include, but are not limited to natural sweeteners, such as Sugar, Fructose, Honey, Agave, Monk fruit, Stevia, Erythritol, Xylitol, Citrus and Protein extracts, and artificial sweeteners such as Sucralose, Acesulfame K, or a combination of these.
  • colorant or colorants are added next and dissolved in the solution, for example by one or more of the following techniques: gentle stirring, gentle vortexing, gentle heating.
  • the time required for dissolving these components is at least about 5 to 60 minutes. In some embodiments, the time required is about 5 min.
  • salt is added next and dissolved in the solution, for example by one or more of the following techniques: gentle stirring, gentle vortexing, gentle heating.
  • the time required for dissolving these components is at least about 5 to 60 minutes. In some embodiments, the time required is about 5 min.
  • the pH of the finished product is acidic. In some embodiments, the pH of the finished product is about 3 to about 4. In some embodiments, the pH of the finished product is about 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9 or 4.0.
  • the composition comprises the following active ingredients in the indicated amounts in one dose or serving of the composition, for example in a daily dose: 0.0001-2 g of Acetyl-L-carnitine; 0.0001-1 g of Choline bitartrate; 0.0001-1 g of Inositol; 0.0001-1 g of N-Acetyl L-tyrosine; 0.0001-800 mg of L-Theanine; and 0.0001-30 mg of PQQ.
  • a composition prepared according to the methods described herein comprises the following active ingredients in the indicated amounts in one dose or serving of the composition, for example in a daily dose:
  • Vitamins D (0.0001-5,000 IU);
  • Vitamin B6 (0.0001-30 mg);
  • Vitamin B12 (0.0001-3 mg);
  • Acetyl-L-Carnitine (0.0001-2 g);
  • N-Acetyl L-Tyrosine (0.0001-1 g);
  • Vitamin E (0.0001-400 IU).
  • the composition comprises about 0.0001—about 5,000 IU of Vitamins D per daily dose or serving.
  • the composition comprises about 0.0001—about 200 mg of Niacin per daily dose or serving.
  • the composition comprises about 0.0001—about 30 mg of Vitamin B6 per daily dose or serving.
  • the composition comprises about 0.0001—about 3 mg of Vitamin B12 per daily dose or serving.
  • the composition comprises about 0.0001—about 2 g of Acetyl-L-Carnitine per daily dose or serving.
  • the composition comprises about 0.0001—about 1 g of Choline bitartrate per daily dose or serving.
  • the composition comprises about 0.0001—about 1 g of Inositol per daily dose or serving.
  • the composition comprises about 0.0001—about 1 g of N-Acetyl L-Tyrosine per daily dose or serving.
  • the composition comprises about 0.0001—about 800 mg of L-Theanine per daily dose or serving.
  • the composition comprises about 0.0001—about 250 mg of DMAE bitartrate per daily dose or serving.
  • the composition comprises about 0.0001—about 30 mg of PQQ per daily dose or serving.
  • the composition comprises about 0.0001—about 300 mg of Green Tea extract per daily dose or serving.
  • the composition comprises about 0.0001—about 400 IU of Vitamin E per daily dose or serving.
  • the composition is formulated as a single serving to be taken once per day by a subject.
  • a daily dose of active ingredients is provided in a single serving.
  • one daily dose may be divided among two or more servings to be taken in a day, for example among two or more servings of a liquid beverage or two or more tablets.
  • a daily dose of the composition is preferably taken by or administered to a subject in a 24-hour period.
  • a daily dose of the composition is taken every day for 1 week to 12 months.
  • the composition is taken for 1, 2, 3 or 4 weeks.
  • the composition is taken for 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 or 12 months.
  • the composition is taken in the morning on an empty stomach. In some embodiments, the composition is taken at any time mental focus and clarity is needed. In some embodiments, the composition is taken daily to promote brain health. In some embodiments, the composition is taken to promote restful sleep. In some embodiments, the composition is taken to promote a feeling of overall well-being.
  • a daily dose of the composition can be provided in one or more daily servings.
  • a daily dose is provided in a single serving.
  • a daily dose may be provided in two or more servings (up to 5 servings in 24 hours). While the size/amount of each serving may vary, the quantity of active ingredients to be consumed will be equal to one serving. In the case of a single serving, where one single serving is intended to be taken per day, the single serving will comprise a complete daily dose. In the case of multiple servings, the quantity of active ingredients will be such that the total amount of active ingredients in the servings to be taken in a single day is equivalent to a daily dose.
  • a single serving of the liquid drink composition comprised of about 4.5 fl. oz.
  • the size of the serving itself may vary depending on the quantity of the inactive ingredients, such as water, the amount of the active ingredients in each single serving will be within the ranges provided herein.
  • the single serving size may be 1 ⁇ 2 fl. oz., 1 fl. oz., 2 fl. oz., 4 fl. oz., 6 fl. oz., 10 fl. oz., 12 fl. oz., 16 fl. oz. or anything smaller or larger, the daily dose of active ingredients will be the same in each serving.
  • a single serving is about 2 fl. oz. to about 54 fl. oz.
  • the composition is a liquid concentrate comprising of multiple servings to be diluted into a liquid beverage to obtain 1 serving sizes.
  • the product is cold filled. In some embodiments, the product is pasteurized. In some embodiments, the product is pasteurized and/or cold filled.
  • the combination of active ingredients provides health benefits when administered to a human subject, particularly brain health benefits.
  • the composition targets six key factors that are important to brain health. These include neurotransmission, axon regeneration, BACE1 metabolism/inhibition, tau-protein metabolism/inhibition, mitochondrial function, and antioxidant protection.
  • the combination of active ingredients provides health benefits when administered to a human subject, particularly brain health benefits.
  • the liquid composition is intended to improve focus, clarity, concentration, mental performance and overall well-being.
  • the combination of active ingredients provides health benefits when administered to a human subject, particularly brain health benefits.
  • the liquid composition in the long term, is intended to support long-term memory, cognitive support, promote mood stability, restful sleep and improved nerve cell-integrity.
  • the active ingredients of the composition provide support for the various aspects of brain health.
  • neurotransmission may be supported by PQQ, DMAE bitartrate, Vitamin D, Choline, Inositol, Vitamin B12, Vitamin B6, Acetyl-L-Carnitine, N-Acetyl L-Tyrosine, L-Theanine, and Green Tea extract.
  • antioxidant protection may be provided by PQQ, Green Tea extract, Acetyl-L-Carnitine, L-Theanine, N-acetyl L-Tyrosine; Axon regeneration support by PQQ, Niacin, Vitamin D, Green Tea extract.
  • mitochondrial function may be supported by PQQ, Niacin, Vitamin D, Choline, Inositol, L-Theanine and Acetyl-L-Carnitine.
  • tau protein metabolism may be supported by Vitamin B6, Vitamin B 12, and BACE1 metabolism by DMAE bitartrate, Choline, Inositol, and Vitamin B6.
  • the composition supports or provides at least one of neurotransmission support, axon regeneration support, BACE1 metabolism/inhibition, tau-protein metabolism/inhibition, mitochondrial function support, and antioxidant protection.
  • At least 1, 2, 3, 4, 5 or more servings can be taken at any time that any one or more of: improvements to vascular health, improvements to neuronal health, and/or improvements to brain health (including, but not limited to the following: high levels of concentration, optimal cognitive function, effective decision making, keen comprehension, effortless recall, mental clarity, quick reflexes, restful sleep, increased motivation, coordinated motor function, efficient problem solving, mental acuity, optimal energy levels, overall well-being, ability to focus, mood stability, memory support, alertness, improved neurotransmission, and nerve cell integrity) is needed or desired.
  • improvements to vascular health including, but not limited to the following: high levels of concentration, optimal cognitive function, effective decision making, keen comprehension, effortless recall, mental clarity, quick reflexes, restful sleep, increased motivation, coordinated motor function, efficient problem solving, mental acuity, optimal energy levels, overall well-being, ability to focus, mood stability, memory support, alertness, improved neurotransmission, and nerve cell integrity
  • Step 1 L-Theanine is added to water.
  • the water may be, for example, tap water, distilled water, or reverse osmosis water.
  • the L-Theanine and water are mixed until the L-theanine is solubilized throughout water. This can take 5-20 minutes.
  • Step 2 The following components are added individually to the solution in the any order: Acetyl-L-Carnitine, Choline bitartrate, Inositol, N-Acetyl L-Tyrosine, and PQQ. Mix until dissolved. This can take 5-10 minutes. In some embodiments these ingredients are added as part of a premix.
  • Step 3 The following components are added individually to the water and L-theanine solution in the following order: DMAE Bitartrate, Vitamin D, Niacin, Vitamin B6and Vitamin B12 and mixed until dissolved. This can take 10-20 minutes. In some embodiments these ingredients are added as a single premix.
  • Step 4 Green tea extract is added and mixed for 5 minutes or until dissolved.
  • Step 5 Vitamin E is added and mixed for 10 minutes or until dissolved.
  • Step 6 Finally, all flavoring components are added and mixed until dissolved.
  • Flavoring components may comprise natural flavors, and sweetener system. Dissolving can take 5-10 minutes.
  • the amount of each ingredient is selected to obtain a liquid composition of which a single serving contains an amount of each active ingredient as described above.
  • composition made using an embodiment of the methods described herein is provided.
  • a liquid composition is prepared by initially combining L-theanine and water. Additional ingredients are subsequently added such that the final liquid composition comprises: Water 135 ml, L-Theanine 200 mg, Vitamin D 400 IU, Niacin 150 mg, Vitamin B6 30 mg, Vitamin B12 500 mcg, PQQ 5 mg, Acetyl-L-Carnitine 500 mg, Choline bitartrate 300 mg, Inositol 250 mg, N-Acetyl L-Tyrosine 250 mg, DMAE bitartrate 75 mg, Green tea extract 85 mg, and Vitamin E 30 IU.
  • Non-limiting ingredients in the composition can include Natural Flavors 0.880 mg, Cane sugar 3 g, Citric acid 150 mg, Stevia 80 mg, and Talin 50 mg.
  • a liquid composition is prepared by initially mixing L-Theanine with water to form a solution. Following the mixing of L-Theanine and water, additional ingredients are added to obtain a liquid composition of which a single serving comprises the following components:
  • Non-limiting ingredients in the composition can include Natural Flavors 0.001 mg-1,000 mg, Cane sugar 0.001 mg-10 g, Citric acid 0.001 mg -500 mg, Stevia 0.001 mg-500 mg, and Talin 0.001 mg-500 mg.

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Abstract

Methods of making liquid compositions that can be used, for example, to improve human health, and in particular brain health are provided. The L-Theanine is solubilized in water prior to the addition of other ingredients, such as Acetyl-L-Carnitine, Choline bitartrate, Inositol, N-Acetyl L-Tyrosine and pyrroloquinoline quinone (PQQ). In some embodiments, additional ingredients such as DMAE bitartrate, Vitamin D, Niacin, Vitamin B6, Vitamin B12, Vitamin E and Green Tea Extract are added. In addition, in some embodiments, natural flavors and natural sweeteners are added. The compositions may be administered to a subject, for example in the form of a liquid drink, to improve brain health.

Description

    CROSS REFERENCE TO RELATED APPLICATIONS
  • This application claims the benefit of U.S. Provisional Application No. 62/259,260, filed on Nov. 24, 2015, and U.S. Provisional Application No. 62/250,854, filed on Nov. 4, 2015, each of which is hereby incorporated by reference in its entirety.
    • FIELD
  • The present disclosure relates to methods of making a liquid composition which, in some embodiments can be used to improve human health, in particular, human brain health.
  • In the short term, the liquid composition is intended to improve focus, clarity, concentration, mental performance and overall well-being. In the long term, the liquid composition is intended to support brain health, especially six key areas to brain health: neurotransmission support, axon regeneration, BACE1 metabolism/inhibition, tau-protein metabolism/inhibition, mitochondrial function, and antioxidant protection. Also in the long term, the liquid composition is intended to support long-term memory, cognitive support, promote mood stability, restful sleep and improved nerve cell-integrity.
    • SUMMARY
  • In some embodiments, methods of making a liquid dietary supplement composition are provided. In some embodiments, the methods comprise preparing a solution by dissolving L-Theanine in water; and subsequently dissolving Acetyl L-Carnitine, Choline Bitartrate, Inositol, N-Acetyl L-Tyrosine and PQQ in the solution. In some embodiments DMAE Bitartrate is dissolved in the solution.
  • In some embodiments of the methods Acetyl L-Carnitine, Choline Bitartrate, Inositol, N-Acetyl L-Tyrosine and PQQ are added to the solution in the form of a single premix.
  • In some embodiments of the methods, Vitamin D, Niacin, Vitamin B6, and Vitamin B12 are added to the solution. In some embodiments, the methods additionally comprise dissolving Green Tea Extract in the solution. In some embodiments, the methods additionally comprise dissolving Vitamin E in the solution.
  • In some embodiments, the methods additionally comprise dissolving one or more flavoring components in the solution. In some embodiments of the methods, the flavoring components comprise one or more of natural flavors and/or natural sweeteners.
  • In some embodiments, a composition produced by the methods comprises 0.0001-800 mg of L-Theanine; 0.0001-5,000 IU of Vitamin D; 0.0001-200 mg of Niacin; 0.0001-30 mg of Vitamin B6; 0.0001-3 mg of Vitamin B12; 0.0001-30 mg of PQQ; 0.0001-2 g of Acetyl-L-Carnitine; 0.0001-1 g of Choline bitartrate; 0.0001-1 g of Inositol; 0.0001-1 g of N-Acetyl L-tyrosine; 0.0001-250 mg DMAE bitartrate; 0.0001-300 mg of Green Tea extract; and 0.0001-400 IU of Vitamin E.
  • In some embodiments a serving of the composition comprises 0.0001 to 2 g of Acetyl-L-carnitine; 0.0001 to 1 g of Choline bitartrate; 0.0001 to 1 g of Inositol; 0.0001 to 1 g of N-Acetyl L-tyrosine; 0.0001 to 800 mg of L-Theanine; and 0.0001 to 30 mg of PQQ in a volume of 2 fl. oz. to 54 fl. oz. In some embodiments the serving is 4.5 fl. oz.
  • In another aspect, methods are provided in which a liquid composition is prepared by forming a solution of L-theanine in water and subsequently adding Pyrroloquinoline Quinone (PQQ), Acetyl-L-Carnitine, Choline bitartrate, Inositol, N-Acetyl L-Tyrosine, DMAE bitartrate, Vitamin D, Niacin, Vitamin B6, Vitamin B12, Green Tea extract and Vitamin E to the solution. One or more flavoring components can be subsequently added to the solution.
  • In some embodiments a volume of 2 fl. oz to 54 fl. oz. of the solution comprises: 0.0001 to about 800 mg of L-Theanine; 0.0001 to about 30 mg of PQQ; 0.0001 to about 2 g of Acetyl-L-Carnitine; 0.0001 to about 1 g of Choline bitartrate; 0.0001 to about 1 g of Inositol; 0.0001 to about 1 g of N-Acetyl L-Tyrosine; 0.0001 to about 250 mg of DMAE bitartrate; 0.0001 to 5,000 IU of Vitamin D; 0.0001 to 200 mg of Niacin; 0.0001 to 30 mg of Vitamin B6; 0.0001 to 3 mg of Vitamin B12; 0.0001 to about 300 mg of Green Tea; and 0.0001 to about 400 IU of Vitamin E. In some embodiments the volume is 4.5 fl. oz.
    • DETAILED DESCRIPTION
  • Many ingredients in liquid dietary supplements are pH dependent and if not added in the correct order can form a sediment and/or precipitate, resulting in particles floating on top of or dispersed in the liquid. In many cases, this is undesirable in the liquid product. Thus, there is a need for a process by which a liquid dietary supplement, such as a liquid dietary supplement for brain health, is produced while avoiding problems resulting from the order of addition of ingredients.
  • In some embodiments, methods for making a liquid dietary supplement composition are described, where the liquid dietary supplement comprises one or more ingredients that are prone to floatation, sedimentation or precipitation. In some embodiments, methods of making a liquid dietary supplement drink using a combination of synergistic ingredients that target long and short-term human brain health are described in which the formation of floaties (precipitate) or bottom-settlement (sediment) in the composition is reduced or avoided entirely.
  • In some embodiments, the generation of a sediment and/or precipitate can be reduced or avoided by combining the ingredients in one or more particular sequences. Thus, in some embodiments special attention is given to the order in which each ingredient is added. In particular, in some embodiments the ingredients are added in an order which results in all of the ingredients going into solution, or staying in suspension.
  • In addition to avoiding precipitation and sedimentation, other indicators of stability of the composition can be preserved during preparation of the liquid composition. These indicators of stability of the composition may include, for example, flavor profile, texture and mouth-feel. Thus in some embodiments, one or more indicator of stability, such as flavor profile, texture and mouth-feel of the composition prepared according to the methods described herein are substantially as desired.
  • In some embodiments the composition comprises Inositol, N-Acetyl L-Tyrosine, pyrroloquinoline quinone (PQQ), Acetyl-L-Carnitine and Choline bitartrate and L-Theanine as active ingredients. In some embodiments the composition additionally comprises Dimethylaminoethyl (DMAE) bitartrate.
  • In some embodiments the composition may comprise one or more of Vitamin E, Vitamin D, Niacin, Vitamin B6, Vitamin B 12, and Green Tea extract.
  • In some embodiments the composition comprises Acetyl L-Carnitine, Choline bitartrate, Inositol, N-Acetyl L-Tyrosine, L-Theanine and pyrroloquinoline quinone (PQQ), as well as one or more of Dimethylaminoethyl (DMAE) bitartrate, Vitamin E, Vitamin D, Niacin, Vitamin B6, Vitamin B12, and Green Tea extract as active ingredients.
  • In some embodiments the composition comprises Inositol, N-Acetyl L-Tyrosine, Dimethylaminoethyl (DMAE) bitartrate, pyrroloquinoline quinone (PQQ), Acetyl-L-Carnitine, Choline bitartrate, L-Theanine and one or more of Vitamin E, Vitamin D, Niacin, Vitamin B6, Vitamin B 12, L-Theanine and Green Tea extract as active ingredients.
  • In some embodiments the composition comprises at least Inositol, N-Acetyl L-Tyrosine, Dimethylaminoethyl (DMAE) bitartrate, pyrroloquinoline quinone (PQQ), Acetyl-L-Carnitine, Choline bitartrate, Vitamin E, Vitamin D, Niacin, Vitamin B6, Vitamin B 12, L-Theanine and Green Tea extract as active ingredients.
  • In some embodiments the composition may comprise one or more additional active ingredients such as alpha-GPC (alpha-glycerylphosphorylcholine), Citicholine, Phosphatidylserine, Astaxanthin, Flaxseed, MCT (Medium Chain Triglycerides), Whole Coffee Fruit extract, Ginko biloba, Vinpocetine, Panax ginseng, Ashwaghanda, Bacopa monnieri, Grape seed extract, dark skinned berries and fruits known for their high concentrations of polyphenols/anthocyanidins, omega-3 fatty acids, omega-6 fatty acids, omega-9 fatty acids, Huperzine A, alpha-Lipoic acid., Magnesium and Zinc.
  • In some embodiments L-Theanine is the first ingredient added to water or other liquid in preparing a liquid composition. Flavor components, colorants and sweeteners, if any, are typically added last. The remaining ingredients may be added in any order or combination. However, as discussed below in some embodiments additional ingredients are added in a specific order.
  • In some embodiments the composition is provided in the form of a liquid drink. The liquid drink may comprise the active ingredients in a water base, or in another base liquid that is inert with respect to the active ingredients. The liquid drink may comprise one or more additional inactive ingredients. In some embodiments the liquid drink may comprise one or more preservatives such as citrus oil, sorbates and benzoates. The liquid drink may also comprise one or more flavors such as fruit (e.g. strawberry, melon, etc.) and non-fruit flavors. In some embodiments the flavor is a natural flavor.
  • In some embodiments the composition, such as a liquid drink, may comprise a sweetener, such as sucralose or acesulfame K or a combination of these. In some embodiments the sweetener is a natural sweetener such as sugar, fructose, honey, agave, monk fruit, stevia, erythritol, xylitol, citrus and protein extracts or a combination of these.
  • As mentioned above, in some embodiments a liquid composition is prepared by adding L-Theanine to a liquid to form a solution. Additional ingredients are subsequently added. The additional ingredients may be added singly or in combination. However, the quantity and order of addition of the additional ingredients is selected such that each additional ingredient goes into solution in the liquid.
  • In some embodiments, a liquid composition is prepared by combining the following components:
  • 1) Water,
  • 2) L-Theanine,
  • 3) PQQ,
  • 4) Acetyl-L-Carnitine,
  • 5) Choline bitartrate,
  • 6) Inositol, and
  • 7) N-Acetyl L-Tyrosine.
  • In some embodiments the water and L-Theanine are combined first to form a solution and the remaining ingredients are added subsequently, either singly or in combination.
  • In some embodiments DMAE bitartrate is added to the liquid composition. In some embodiments DMAE is added simultaneously with or subsequent to one or more of the first seven ingredients. In some embodiments DMAE is added after the first seven ingredients as listed above.
  • In some embodiments, a liquid composition is prepared by combining the following components:
  • 1) Water,
  • 2) L-Theanine,
  • 3) Vitamin D,
  • 4) Niacin,
  • 5) Vitamin B6,
  • 6) Vitamin B 12,
  • 7) PQQ,
  • 8) Acetyl-L-Carnitine,
  • 9) Choline bitartrate,
  • 10) Inositol,
  • 11) N-Acetyl L-Tyrosine,
  • 12) DMAE bitartrate,
  • 13) Green tea extract, and
  • 14) Vitamin E.
  • In addition, in some embodiments flavor components and sweeteners may be added.
  • In some embodiments the water and L-Theanine are combined first to form a solution and the remaining ingredients are added subsequently, either singly or in combination.
  • In some embodiments the first 12 ingredients are combined prior to subsequent addition of the Green Tea Extract and Vitamin E, in that order.
  • In some embodiments, a liquid composition is prepared by combining the following components in the order provided below:
  • 1) Water,
  • 2) L-Theanine,
  • 3) PQQ,
  • 4) Acetyl-L-Carnitine,
  • 5) Choline bitartrate,
  • 6) Inositol, and
  • 7) N-Acetyl L-Tyrosine.
  • In some embodiments DMAE bitartrate is subsequently added after the N-Acetyl L-Tyrosine.
  • In some embodiments flavoring agents, sweeteners and/or preservatives are optionally added after the listed ingredients.
  • In some embodiments, a liquid composition is prepared by combining the following components in the order provided below:
  • 1) Water,
  • 2) L-Theanine,
  • 3) PQQ,
  • 4) Acetyl-L-Carnitine,
  • 5) Choline bitartrate,
  • 6) Inositol,
  • 7) N-Acetyl L-Tyrosine,
  • 8) DMAE bitartrate,
  • 9) Vitamin D,
  • 10) Niacin,
  • 11) Vitamin B6,
  • 12) Vitamin B 12,
  • 13) Green tea extract,
  • 14) Vitamin E,
  • 15) Flavor components, and
  • 16) Sweeteners.
  • In some embodiments one or more of the 16 listed components may be omitted; however, the remaining components are added in the specified order.
  • As discussed above, in some embodiments, a liquid composition is formed by initially combining a L-Theanine and water or other liquid.
  • L-Theanine is added in an amount sufficient to achieve the desired concentration of L-Theanine in the liquid drink composition.
  • L-Theanine is preferably added to the water prior to any other ingredients in order to allow for optimum solubility throughout the liquid phase. If L-Theanine is not added as the first ingredient, added as the last ingredient and/or added as part of a premix comprising other ingredients, the L-theanine may not completely dissolve in the water. This can interfere with the dispersion and solubility of other ingredients throughout the liquid phase and may, for example, lead to clumps (precipitation) and/or fall-out (sedimentation) throughout the liquid. Thus, L-Theanine is the first ingredient added in some embodiments.
  • In some embodiments, the other ingredients are added to a solubilized L-theanine in water individually and sequentially in any order. However, in some embodiments the other ingredients are added to a solubilized L-theanine in water individually in a specified order, such as in the specific embodiments discussed above.
  • In some embodiments, one or more additional ingredients are added to the L-Theanine and water solution as one or more premixes, each comprising a fraction of the other ingredients. The premixes may be added in multiple steps or in a single step.
  • In some embodiments, all additional ingredients are added to the L-Theanine and water solution as a single premix comprising all the additional ingredients.
  • In some embodiments Inositol, N-Acetyl L-Tyrosine, Pyrroloquinoline Quinone (PQQ), Acetyl-L-Carnitine and Choline bitartrate are dissolved in an L-Theanine and water solution, either sequentially or as a premix containing some or all of the components.
  • In some embodiments Inositol, N-Acetyl L-Tyrosine, Pyrroloquinoline Quinone (PQQ), Acetyl-L-Carnitine, Choline bitartrate and Dimethylaminoethyl (DMAE) bitartrate, are dissolved in an L-Theanine and water solution, either sequentially or as a premix containing some or all of the components.
  • In some embodiments Inositol, N-Acetyl L-Tyrosine, Dimethylaminoethyl (DMAE) bitartrate, Pyrroloquinoline Quinone (PQQ), Acetyl-L-Carnitine, Choline bitartrate, Vitamin E, Vitamin D, Niacin, Vitamin B6, Vitamin B12, and Green Tea extract are dissolved in a solution of L-Theanine and water, either individually or as a premix containing two or more of the components. In some embodiments Green Tea extract and Vitamin E are added last.
  • In some embodiments, Acetyl-L-Carnitine, Choline bitartrate, Inositol, N-Acetyl L-Tyrosine, PQQ are added individually and sequentially to the L-Theanine and water solution. In some embodiments, Acetyl-L-Carnitine, Choline bitartrate, Inositol, N-Acetyl L-Tyrosine, and PQQ are added to the L-Theanine and water solution as a single premix comprising all the ingredients.
  • In some embodiments, the time required for dissolving the additional components in the L-Theanine and water solution is at least about 10 to about 60 minutes. In some embodiments, the time required is about 10 to about 20 minutes. In some embodiments, the time required is about 20 to about 60 minutes.
  • In some embodiments, Acetyl-L-Carnitine, Choline bitartrate, Inositol, N-Acetyl L-Tyrosine, and PQQ are dissolved in the solution of water and L-Theanine, for example by one or more of the following techniques: gentle stirring, gentle vortexing, and gentle heating. In some embodiments, the time required for dissolving these components is at least about 5 to about 60 minutes. In some embodiments, the time required is about 5 to about 10 minutes. In some embodiments, the time required is about 10 to about 60 minutes.
  • In some embodiments, one or more additional ingredients such as Dimethylaminoethyl (DMAE) bitartrate, Vitamin E, Vitamin D, Niacin, Vitamin B6, Vitamin B12, and Green Tea extract are dissolved in the solution, for example by one or more of the following techniques: gentle stirring, gentle vortexing, gentle heating. In some embodiments, the time required for dissolving these components is at least about 5 to about 60 minutes. In some embodiments, the time required is about 5 min.
  • Flavoring components can also be added to the solution. In some embodiments, any and all flavoring components, such as Natural flavors, and sweeteners are added next individually and sequentially in any order. In some embodiments, the order of addition is Natural flavors, and sweetener system.
  • The flavoring components may be dissolved in the solution, for example by one or more of the following techniques: gentle stirring, gentle vortexing, gentle heating. In some embodiments, the time required for dissolving these components is at least about 5 to about 60 minutes. In some embodiments, the time required is about 5 to about 10 minutes. In some embodiments, the time required is about 10 to about 60 minutes.
  • In some embodiments, the flavoring components comprise Natural flavors, and one or more sweeteners. Exemplary sweeteners include, but are not limited to natural sweeteners, such as Sugar, Fructose, Honey, Agave, Monk fruit, Stevia, Erythritol, Xylitol, Citrus and Protein extracts, and artificial sweeteners such as Sucralose, Acesulfame K, or a combination of these.
  • In some embodiments colorant or colorants are added next and dissolved in the solution, for example by one or more of the following techniques: gentle stirring, gentle vortexing, gentle heating. In some embodiments, the time required for dissolving these components is at least about 5 to 60 minutes. In some embodiments, the time required is about 5 min.
  • In some embodiments salt is added next and dissolved in the solution, for example by one or more of the following techniques: gentle stirring, gentle vortexing, gentle heating. In some embodiments, the time required for dissolving these components is at least about 5 to 60 minutes. In some embodiments, the time required is about 5 min.
  • In some embodiments, the pH of the finished product is acidic. In some embodiments, the pH of the finished product is about 3 to about 4. In some embodiments, the pH of the finished product is about 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9 or 4.0.
  • In some embodiments, the composition comprises the following active ingredients in the indicated amounts in one dose or serving of the composition, for example in a daily dose: 0.0001-2 g of Acetyl-L-carnitine; 0.0001-1 g of Choline bitartrate; 0.0001-1 g of Inositol; 0.0001-1 g of N-Acetyl L-tyrosine; 0.0001-800 mg of L-Theanine; and 0.0001-30 mg of PQQ.
  • In some embodiments, a composition prepared according to the methods described herein comprises the following active ingredients in the indicated amounts in one dose or serving of the composition, for example in a daily dose:
  • Vitamins D (0.0001-5,000 IU);
  • Niacin (0.0001-200 mg);
  • Vitamin B6 (0.0001-30 mg);
  • Vitamin B12 (0.0001-3 mg);
  • Acetyl-L-Carnitine (0.0001-2 g);
  • Choline bitartrate (0.0001-1 g);
  • Inositol (0.0001-1 g);
  • N-Acetyl L-Tyrosine (0.0001-1 g);
  • L-Theanine (0.0001-800 mg);
  • DMAE bitartrate (0.0001-250 mg);
  • PQQ (0.0001-30 mg);
  • Green tea extract (0.0001-300 mg); and
  • Vitamin E (0.0001-400 IU).
  • In some embodiments, the composition comprises about 0.0001—about 5,000 IU of Vitamins D per daily dose or serving.
  • In some embodiments, the composition comprises about 0.0001—about 200 mg of Niacin per daily dose or serving.
  • In some embodiments, the composition comprises about 0.0001—about 30 mg of Vitamin B6 per daily dose or serving.
  • In some embodiments, the composition comprises about 0.0001—about 3 mg of Vitamin B12 per daily dose or serving.
  • In some embodiments, the composition comprises about 0.0001—about 2 g of Acetyl-L-Carnitine per daily dose or serving.
  • In some embodiments, the composition comprises about 0.0001—about 1 g of Choline bitartrate per daily dose or serving.
  • In some embodiments, the composition comprises about 0.0001—about 1 g of Inositol per daily dose or serving.
  • In some embodiments, the composition comprises about 0.0001—about 1 g of N-Acetyl L-Tyrosine per daily dose or serving.
  • In some embodiments, the composition comprises about 0.0001—about 800 mg of L-Theanine per daily dose or serving.
  • In some embodiments, the composition comprises about 0.0001—about 250 mg of DMAE bitartrate per daily dose or serving.
  • In some embodiments, the composition comprises about 0.0001—about 30 mg of PQQ per daily dose or serving.
  • In some embodiments, the composition comprises about 0.0001—about 300 mg of Green Tea extract per daily dose or serving.
  • In some embodiments, the composition comprises about 0.0001—about 400 IU of Vitamin E per daily dose or serving.
  • In some embodiments the composition is formulated as a single serving to be taken once per day by a subject. Thus, in some embodiments a daily dose of active ingredients is provided in a single serving. In some embodiments one daily dose may be divided among two or more servings to be taken in a day, for example among two or more servings of a liquid beverage or two or more tablets. A daily dose of the composition is preferably taken by or administered to a subject in a 24-hour period. In some embodiments, a daily dose of the composition is taken every day for 1 week to 12 months. In some embodiments, the composition is taken for 1, 2, 3 or 4 weeks. In some embodiments, the composition is taken for 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 or 12 months.
  • In some embodiments, the composition is taken in the morning on an empty stomach. In some embodiments, the composition is taken at any time mental focus and clarity is needed. In some embodiments, the composition is taken daily to promote brain health. In some embodiments, the composition is taken to promote restful sleep. In some embodiments, the composition is taken to promote a feeling of overall well-being.
  • As mentioned above, in some embodiments a daily dose of the composition can be provided in one or more daily servings. In some embodiments a daily dose is provided in a single serving. In some embodiments a daily dose may be provided in two or more servings (up to 5 servings in 24 hours). While the size/amount of each serving may vary, the quantity of active ingredients to be consumed will be equal to one serving. In the case of a single serving, where one single serving is intended to be taken per day, the single serving will comprise a complete daily dose. In the case of multiple servings, the quantity of active ingredients will be such that the total amount of active ingredients in the servings to be taken in a single day is equivalent to a daily dose.
  • In some embodiments, a single serving of the liquid drink composition comprised of about 4.5 fl. oz. However, the skilled artisan will appreciate that while the size of the serving itself may vary depending on the quantity of the inactive ingredients, such as water, the amount of the active ingredients in each single serving will be within the ranges provided herein. For example, while the single serving size may be ½ fl. oz., 1 fl. oz., 2 fl. oz., 4 fl. oz., 6 fl. oz., 10 fl. oz., 12 fl. oz., 16 fl. oz. or anything smaller or larger, the daily dose of active ingredients will be the same in each serving. In some embodiments a single serving is about 2 fl. oz. to about 54 fl. oz. In some embodiments, the composition is a liquid concentrate comprising of multiple servings to be diluted into a liquid beverage to obtain 1 serving sizes.
  • In some embodiments, the product is cold filled. In some embodiments, the product is pasteurized. In some embodiments, the product is pasteurized and/or cold filled.
  • The combination of active ingredients provides health benefits when administered to a human subject, particularly brain health benefits. For example, in some embodiments, the composition targets six key factors that are important to brain health. These include neurotransmission, axon regeneration, BACE1 metabolism/inhibition, tau-protein metabolism/inhibition, mitochondrial function, and antioxidant protection.
  • The combination of active ingredients provides health benefits when administered to a human subject, particularly brain health benefits. For example, in some embodiments, in the short term, the liquid composition is intended to improve focus, clarity, concentration, mental performance and overall well-being.
  • The combination of active ingredients provides health benefits when administered to a human subject, particularly brain health benefits. For example, in some embodiments, in the long term, the liquid composition is intended to support long-term memory, cognitive support, promote mood stability, restful sleep and improved nerve cell-integrity.
  • The active ingredients of the composition provide support for the various aspects of brain health. For example, in some embodiments neurotransmission may be supported by PQQ, DMAE bitartrate, Vitamin D, Choline, Inositol, Vitamin B12, Vitamin B6, Acetyl-L-Carnitine, N-Acetyl L-Tyrosine, L-Theanine, and Green Tea extract. In some embodiments, antioxidant protection may be provided by PQQ, Green Tea extract, Acetyl-L-Carnitine, L-Theanine, N-acetyl L-Tyrosine; Axon regeneration support by PQQ, Niacin, Vitamin D, Green Tea extract. In some embodiments, mitochondrial function may be supported by PQQ, Niacin, Vitamin D, Choline, Inositol, L-Theanine and Acetyl-L-Carnitine. In some embodiments tau protein metabolism may be supported by Vitamin B6, Vitamin B 12, and BACE1 metabolism by DMAE bitartrate, Choline, Inositol, and Vitamin B6.
  • Thus, in some embodiments, the composition supports or provides at least one of neurotransmission support, axon regeneration support, BACE1 metabolism/inhibition, tau-protein metabolism/inhibition, mitochondrial function support, and antioxidant protection.
  • In some embodiments, at least 1, 2, 3, 4, 5 or more servings can be taken at any time that any one or more of: improvements to vascular health, improvements to neuronal health, and/or improvements to brain health (including, but not limited to the following: high levels of concentration, optimal cognitive function, effective decision making, keen comprehension, effortless recall, mental clarity, quick reflexes, restful sleep, increased motivation, coordinated motor function, efficient problem solving, mental acuity, optimal energy levels, overall well-being, ability to focus, mood stability, memory support, alertness, improved neurotransmission, and nerve cell integrity) is needed or desired.
  • The following Examples provide non-limiting embodiments, of the method of making a liquid composition and a composition made by an embodiment of the method of the present disclosure.
  • EXAMPLE 1
  • A non-limiting embodiment of the methods according to which the ingredients of the composition are mixed in the order defined by the steps below is provided.
  • Step 1: L-Theanine is added to water. The water may be, for example, tap water, distilled water, or reverse osmosis water. The L-Theanine and water are mixed until the L-theanine is solubilized throughout water. This can take 5-20 minutes.
  • Step 2: The following components are added individually to the solution in the any order: Acetyl-L-Carnitine, Choline bitartrate, Inositol, N-Acetyl L-Tyrosine, and PQQ. Mix until dissolved. This can take 5-10 minutes. In some embodiments these ingredients are added as part of a premix.
  • Step 3: The following components are added individually to the water and L-theanine solution in the following order: DMAE Bitartrate, Vitamin D, Niacin, Vitamin B6and Vitamin B12 and mixed until dissolved. This can take 10-20 minutes. In some embodiments these ingredients are added as a single premix.
  • Step 4: Green tea extract is added and mixed for 5 minutes or until dissolved.
  • Step 5: Vitamin E is added and mixed for 10 minutes or until dissolved.
  • Step 6: Finally, all flavoring components are added and mixed until dissolved. Flavoring components may comprise natural flavors, and sweetener system. Dissolving can take 5-10 minutes.
  • The amount of each ingredient is selected to obtain a liquid composition of which a single serving contains an amount of each active ingredient as described above.
  • EXAMPLE 2
  • A non-limiting example of a composition made using an embodiment of the methods described herein is provided.
  • A liquid composition is prepared by initially combining L-theanine and water. Additional ingredients are subsequently added such that the final liquid composition comprises: Water 135 ml, L-Theanine 200 mg, Vitamin D 400 IU, Niacin 150 mg, Vitamin B6 30 mg, Vitamin B12 500 mcg, PQQ 5 mg, Acetyl-L-Carnitine 500 mg, Choline bitartrate 300 mg, Inositol 250 mg, N-Acetyl L-Tyrosine 250 mg, DMAE bitartrate 75 mg, Green tea extract 85 mg, and Vitamin E 30 IU.
  • Other non-limiting ingredients in the composition can include Natural Flavors 0.880 mg, Cane sugar 3 g, Citric acid 150 mg, Stevia 80 mg, and Talin 50 mg.
  • EXAMPLE 3
  • A liquid composition is prepared by initially mixing L-Theanine with water to form a solution. Following the mixing of L-Theanine and water, additional ingredients are added to obtain a liquid composition of which a single serving comprises the following components:
  • 0.0001—about 5,000 IU of Vitamin D; 0.0001-200 mg of Niacin; 0.0001 -30 mg of Vitamin B6; 0.0001-3 mg of Vitamin B12; 0.0001-2 g of Acetyl-L-Carnitine; 0.0001-1 g of Choline bitartrate; 0.0001-1 g of Inositol; 0.0001-1 g of N-Acetyl L-Tyrosine; 0.0001-600 mg of L-Theanine; 0.0001-250 mg DMAE bitartrate; 0.0001-30 mg of PQQ; and 0.0001-300 mg of Green tea extract;
  • Other non-limiting ingredients in the composition can include Natural Flavors 0.001 mg-1,000 mg, Cane sugar 0.001 mg-10 g, Citric acid 0.001 mg -500 mg, Stevia 0.001 mg-500 mg, and Talin 0.001 mg-500 mg.

Claims (39)

1. A method of making a liquid composition, the method comprising:
preparing a solution by dissolving L-Theanine in water; and subsequently dissolving Acetyl-L-Carnitine, Choline bitartrate, Inositol, N-Acetyl L-Tyrosine and Pyrroloquinoline Quinone (PQQ) in the solution.
2. The method of claim 1, additionally comprising dissolving Dimethylaminoethyl (DMAE) bitartrate in the solution.
3. The method of claim 2, wherein Acetyl-L-Carnitine, Choline bitartrate, Inositol, N-Acetyl L-Tyrosine, DMAE bitartrate are added to the solution in the form of a single premix.
4. The method of claim 1 additionally comprising dissolving one or more of Vitamin D, Niacin, Vitamin B6, and Vitamin B12 in the solution.
5. The method of claim 4, additionally comprising dissolving Green tea extract in the solution.
6. The method of claim 5, additionally comprising dissolving Vitamin E in the solution.
7. The method of claim 1, additionally comprising dissolving DMAE, Vitamin D, Niacin, Vitamin B6, Vitamin B 12, Vitamin E and Green Tea Extract in the solution.
8. The method of claim 7, wherein the composition comprises 0.0001 -800 g of L-Theanine; 0.0001-5,000 IU of Vitamin D; 0.0001-200 mg of Niacin; 0.0001-30 mg of Vitamin B6; 0.0001-3 mg of Vitamin B12; 0.0001-30 mg of PQQ; 0.0001-2 g of Acetyl-L-Carnitine; 0.0001-1 g of Choline bitartrate; 0.0001-1 g of Inositol; 0.0001-1 g of N-Acetyl L-tyrosine; 0.0001-250 mg DMAE bitartrate; 0.0001-300 mg of Green Tea extract; and 0.0001-400 IU of Vitamin E.
9. The method of claim 1, additionally comprising dissolving one or more flavoring components in the solution.
10. The method of claim 8, wherein the flavoring components comprise one or more of natural flavors and natural sweeteners.
11. The method of claim 10, wherein the one or more natural sweeteners are selected from sugar, fructose, honey, erythritol, xylitol, stevia, talin, monk fruit, agave, citrus and protein extracts.
12. The method of claim 1, wherein a serving of the composition comprises 0.0001 to 2 g of Acetyl-L-carnitine; 0.0001 to 1 g of Choline bitartrate; 0.0001 to 1 g of Inositol; 0.0001 to 1 g of N-Acetyl L-tyrosine; 0.0001 to 800 mg of L-Theanine; and 0.0001 to 30 mg of PQQ in a volume of 2 fl. oz. to 54 fl. oz.
13. The method of claim 12, wherein the volume is 4.5 fl. oz.
14. A method of preparing a liquid composition comprising forming a solution of L-theanine in water and subsequently adding, Pyrroloquinoline Quinone (PQQ), Acetyl-L-Carnitine, Choline bitartrate, Inositol, N-Acetyl L-Tyrosine, DMAE bitratrate, Vitamin D, Niacin, Vitamin B6, Vitamin B12, Green Tea extract and Vitamin E to the solution.
15. The method of claim 14, additionally comprising adding one or more flavor components to the solution.
16. The method of claim 15, wherein the one or more flavor components comprises a natural sweetener selected from sugar, fructose, honey, agave, monk fruit, stevia, erythritol, xylitol, citrus and protein extracts and combinations thereof.
17. The method of claim 14, wherein the solution comprises 0.0001 to 2 g of Acetyl-L-carnitine; 0.0001 to 1 g of Choline bitartrate; 0.0001 to 1 g of Inositol; 0.0001 to 1 g of N-Acetyl L-tyrosine; 0.0001 to 800 mg of L-Theanine; and 0.0001 to 30 mg of PQQ in a volume of 2 fl. oz. to 54 fl. oz.
18. The method of claim 17, wherein the volume is 4.5 fl. oz.
19. The method of claim 14, wherein a volume of 2 fl. oz to 54 fl. oz. of the solution comprises:
0.0001 to about 800 mg of L-Theanine;
0.0001 to about 30 mg of PQQ;
0.0001 to about 2 g of Acetyl-L-Carnitine;
0.0001 to about 1 g of Choline bitartrate;
0.0001 to about 1 g of Inositol;
0.0001 to about 1 g of N-Acetyl L-Tyrosine;
0.0001 to about 250 mg of DMAE bitartrate;
0.0001 to 5,000 IU of Vitamin D;
0.0001 to 200 mg of Niacin;
0.0001 to 30 mg of Vitamin B6;
0.0001 to 3 mg of Vitamin B12;
0.0001 to about 300 mg of Green Tea; and
0.0001 to about 400 IU of Vitamin E.
20. The method of claim 19, wherein the volume is 4.5 fl. oz.
21. A method of making a liquid composition, the method comprising:
preparing a solution by dissolving L-Theanine in water; and subsequently dissolving Acetyl-L Carnitine, Choline, Inositol, and N-Acetyl L-Tyrosine in the solution.
22. The method of claim 21, comprising dissolving Dimethylaminoethyl (DMAE) bitartrate in the solution.
23. The method of claim 21, wherein Acetyl-L-Carnitine, Choline bitartrate, Inositol, N-Acetyl L-Tyrosine, and DMAE bitartrate are added to the solution in the form of a single premix.
24. The method of claim 21, comprising dissolving one or more of DMAE, Vitamin D, Niacin, Vitamin B6, Vitamin B12, Vitamin E and Green tea extract in the solution.
25. The method of claim 21, comprising dissolving one or more of alpha-GPC (alpha-glycerylphosphorylcholine), Citicholine, Phosphatidylserine, Astaxanthin, Flaxseed, MCT (Medium Chain Triglycerides), caffeine, Whole Coffee Fruit extract, Ginko biloba, Vinpocetine, Panax ginseng, Ashwaghanda, Bacopa monnieri, Grape seed extract, omega-3 fatty acids, omega-6 fatty acids, omega-9 fatty acids, Huperzine A, alpha-Lipoic acid, Magnesium and Zinc in the solution.
26. The method of claim 21, comprising dissolving one or more natural flavors and/or natural sweeteners in the solution.
27. The method of claim 21, comprising dissolving one or more of sugar, fructose, honey, erythritol, xylitol, stevia, talin, monk fruit, agave, citrus and protein extracts.
28. The method of claim 21, comprising dissolving one or more of propylene glycol, xanthan gum, guar gum, acacia gum, fillers, rice flour, methylcellulose, and magnesium stearate in the solution.
29. The method of claim 21, wherein the liquid composition comprises 0.0001 to 2 g of Acetyl-L-carnitine; 0.0001 to 1 g of Choline; 0.0001 to 1 g of Inositol; 0.0001 to 1 g of N-Acetyl L-tyrosine; and 0.0001 to 800 mg of L-Theanine in a volume of 2 fl. oz. to 54 fl. oz.
30. A method of making a liquid composition comprising preparing a solution by dissolving L-Theanine in water; and subsequently dissolving Acetyl-L Carnitine, Choline, and N-Acetyl L-Tyrosine in the solution.
31. The method of claim 30, comprising dissolving Dimethylaminoethyl (DMAE) bitartrate in the solution.
32. The method of claim 30, comprising dissolving Inositol in the solution.
33. The method of claim 30, wherein Acetyl-L-Carnitine, Choline, N-Acetyl L-Tyrosine, and DMAE bitartrate are added to the solution in the form of a single premix.
34. The method of claim 30, comprising dissolving one or more of DMAE, Inositol, Vitamin D, Niacin, Vitamin B6, Vitamin B12, Vitamin E and Green tea extract in the solution.
35. The method of claim 30, comprising dissolving one or more of alpha-GPC (alpha-glycerylphosphorylcholine), Citicholine, Phosphatidylserine, Astaxanthin, Flaxseed, MCT (Medium Chain Triglycerides), caffeine, Whole Coffee Fruit extract, Ginko biloba, Vinpocetine, Panax ginseng, Ashwaghanda, Bacopa monnieri, Grape seed extract, omega-3 fatty acids, omega-6 fatty acids, omega-9 fatty acids, Huperzine A, alpha-Lipoic acid, Magnesium and Zinc in the solution.
36. The method of claim 30, comprising dissolving one or more natural flavors and/or natural sweeteners in the solution.
37. The method of claim 30, comprising dissolving one or more of sugar, fructose, honey, erythritol, xylitol, stevia, talin, monk fruit, agave, citrus and protein extracts.
38. The method of claim 30, comprising dissolving one or more of propylene glycol, xanthan gum, guar gum, acacia gum, fillers, rice flour, methylcellulose, and magnesium stearate in the solution.
39. The method of claim 30, wherein the liquid composition comprises 0.0001 to 2 g of Acetyl-L-carnitine; 0.0001 to 1 g of Choline; 0.0001 to 1 g of N-Acetyl L-tyrosine; and 0.0001 to 800 mg of L-Theanine in a volume of 2 fl. oz. to 54 fl. oz.
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