NEUPANEX®: Neuroprotective, Neuroregenerational, & Neurogenesis Supporting Supplement Combination

Abstract

The present invention provides a dietary supplement that contains necessary ingredients for neurological protection and neurogenesis in one formulation. This dietary supplement comprises combinations of vitamins and substances that are naturally endogenous to the brain, are known to decline with age, injury and disease and are essential for membrane structure, mitochondrial respiration and stem cell differentiation.

Claims

1. A formulation for enhancing the neurological function of a human, via neuronal protection and neuronal regeneration, as a result of scavenging free radicals resulting from injuries, illness or age, by (1) increasing gene expression and (2) protecting healthy cells from neurotoxins released from damaged neurons or glia by mechanisms including, but not limited to, (a) blocking the release of neurotoxins, (b) blocking the receptors for neurotoxins or (c) a combination thereof, (d) suppressing inflammatory responses resulting from the injury or process by decreasing the level of pro-inflammatory cytokines, (e) enhancing cell to cell communication at the membrane lipid rafts, and (f) promoting neurogenesis, (g) promoting neurite outgrowth, or (h) a combination thereof, said formulation consisting of: a. cholesterol; b. coenzyme Q10 or CoQ10; c. acetyl L-carnitine; d. rice extract from rice bran (e.g. Nu-RICE); e. Vitamin C in the form of ascorbic acid calcium ascorbate, sodium ascorbate, and other mineral ascorbates, ascorbic acid with bioflavonoids and combination products; f. lipoic acid or alpha lipoic acid; g. huperizine; h. zinc picolinate; i. pregnenolone; j. folic acid or its derivative, for instance, Quatrefolic or methylfolate; k. Vitamin B12 or methyl Vitamin B12, cobalamin, methylcobalamin, adenosylcobalamin, hydroxycobalamin, or an analog of cobalamin; l. Pyrroloquinoline Quinone (PQQ); m. Vitamin D3, cholecalciferol or ergocalciferol; n. Vitamin K2; o. Vitamin A in the form of palmitate; p. Curcumin; q. phosphatidyl serine; r. phosphatidyl choline; s. phosphatidyl ethanolamine; t. phosphatidyl inositol; u. gamma-aminobutyric acid (GABA) v. an acidity flavor blocker (also referred to as an acid blocker); w. a sugar substitute; and x. flavoring.

2. The formulation of claim 1, wherein the ingredients fall into the following ranges: a. cholesterol in the range of 75 mg-4000 mg, preferably 1.5 grams; b. coenzyme Q10 or CoQ10 in the range of 10 mg to 5000 mg, preferably 1 gram; c. acetyl L-carnitine in the range of 10 mg to 5000 mg, preferably 1 gram; d. rice extract from rice bran (e.g. Nu-RICE) in the range of 10 mg to 5000 mg, preferably 750 mg; e. Vitamin C in the form of ascorbic acid calcium ascorbate, sodium ascorbate, and other mineral ascorbates, ascorbic acid with bioflavonoids and combination products in the range of 20 mg to 10000 mg, preferably 500 mg; f. lipoic acid or alpha lipoic acid in the range of 15 mg to 2000 mg, preferably 400 mg; g. huperizine in the form of huperizine A in the range of 50 mcg to 200 mcg, preferably 100 mcg; h. zinc picolinate in the range of 1 mg to 500 mg, preferably 20 mg; i. pregnenolone in the range of 1 mg to 1000 mg, preferably 20 mg; j. folic acid or its derivative, for instance, Quatrefolic in the range of 0.1 mg to 200 mg, preferably 6 mg; k. Vitamin B12 (methyl b 12) in the range of 0.1 mg to 200 mg, preferably 3 mg; l. Pyrroloquinoline Quinone (PQQ) in the range of 0.1 mg to 200 mg, preferably 20 mg; m. Vitamin D3 in the range of 1 mcg to 500 mg, preferably 125 mcg; n. Vitamin K2 (or K2 mk4) in the range of 1 mcg to 5 mg, preferably 3 mcg; o. Vitamin A in the form of palmitate in the range of 2500 IU to 10000 IU; p. curcumin in the range of 10 mg to 5000 mg, preferably 600 mg; q. phosphatidyl serine in the range of 10 mg to 700 mg, preferably 100 mg; r. phosphatidyl choline in the range of 1 mg to 1000 mg, preferably 25 mg; s. phosphatidyl ethanolamine in the range of 1 mg to 1000 mg, preferably 2.5 mg; t. phosphatidyl inositol in the range of 0.5 mg to 200 mg, preferably 1.5 mg; u. gamma-aminobutyric acid (GABA) in a range of 150 mg to 2000 mg, preferably 1000 mg; v. an acidity flavor blocker in the range of 20 mg to 5000 mg, preferably 1 gram; w. sugar substitute (e.g. Stevia) in the range of 10 mg to 700 mg, preferably 175 mg; and x. flavoring (fruit punch flavor) 50 mg to 3000 mg, preferably 1.5 grams.

3. The formulation of claim 2, wherein phosphatidyl serine, phosphatidyl choline, phosphatidyl ethanolamine, and/or phosphatidyl inositol are included alone or as a phosphatidyl serene complex.

4. The formulation of claim 1, wherein the ingredient melatonin may be included as a neurotoxin suppressant.

5. The formulation of claim 4, wherein dehydroepiandrosterone (DHEA) and/or cannabis, namely cannabidiol (CBD), may be included in therapeutic amounts or absent in the case of competitive athletes and/or pediatric or adolescent populations.

6. The formulation of claim 5, wherein the ingredients may be a derivate, analog or isomer or combination thereof in a pure, substantially pure or synthetic form.

7. The formulation of claim 5, wherein there may be included excipients, binders, fillers, emulsifiers, flavoring agents, disintegrants, pharmaceutically accepted carriers or the like considered generally safe for human consumption that may make the present invention suitable for oral, buccal, sublingual, rectal, transdermal, intravenous, intramuscular, subcutaneous, or intraperitoneal administration.

8. The formulation of claim 5, wherein specific ingredients are co-administered contemporaneously wherein (a) cholesterol are present with phosphatidyl serine and the other phospholipids to repair and generate membranes, (b) phosphatidyl serine and the other phospholipids are present together to make the membrane Sigma 1 receptor for the neurosteroids DHEA and pregnenolone to bind resulting in neurogenesis, free radical scavenging of free radicals and the preserving and augmentation of mitochondrial function (c) ubiquinone, alpha lipoic acid, acetyl carnitine, vitamin K2 simultaneously, alpha lipoic acid, acetyl carnitine, K2, vitamin D, PQQ, melatonin and zinc are all be present in combination to generate new mitochondria (mitochondrial biogenesis) and increase the number of Sigma 1 receptors to stimulate production of brain derived nerve growth factor (BDNF), PQQ and vitamin D and neurosteroids are also be present to block the cytokine and interleukin inflammatory response at all its sites of initiation and propagation, (e) Vitamin A, K2 and D are simultaneously present together to form a heterodimer which binds to the DNA in the nucleus of cells and initiates mRNA coding and cellular function and repair, (f) Vitamin D blocks Ca++ influx to the NMDA receptor, preventing depolarization, while (g) PQQ, DHEA, methylcobalamin and methylfolate and alpha lipoic acid are present to decrease glutamate excitotoxicity and melatonin may be included to block the glutamate receptor.

9. The formulation of claim 5, wherein the individual benefitting from the administration of said formulation may be one who may be suffering from the detrimental effects of one or more of the following, alone or in combination: a. injury (e.g. concussion, spinal cord injury, traumatic brain injury and strokes hemorrhagic and ischemic); b. disease (e.g. Alzheimer's, Dementia, multiple sclerosis, Parkinson's disease, ALS and neurodegenerative disease); c. conditions (e.g. autism, ADHD, Guillain-Barre syndrome); and d. age.

10. A method of protecting and enhancing the neurological function of a human via a multifactorial and comprehensive supplementation of the formulation of claim 6, thereby advancing neuroprotection, neuroregeneration, neurogenesis or a combination thereof, by way of remediating neurodestructive effects by targeting distinct functional areas, comprising: a. measuring the neurological function of a patient; b. assessing and recording the neurological function of a patient; c. introducing orally, nasally, intravenously, subcutaneously, intraperitoneally or rectally a therapeutic amount of the formulation of claim 7, during injury the phase of both neurons and glia resulting in free radical scavenging, wherein the administration of the formulation of claim 7 results in the remediating of free radical release due to gradual or sudden injury, disease or age; said formulation: i. facilitating binding and blocking of glutamate and glutamate receptors for protection of healthy cells from neurotoxins released from damaged neurons or glia; ii. suppressing the inflammatory response through inclusion of anti-inflammatories countering the inflammatory process resulting from injury, age or illness processes; iii. repairing phase enhancement in cell-to-cell communication at the membrane lipid rafts through cholesterol and phospholipids inclusion; iv. promoting neuroprotection and neurogenesis through the addition of sigma 1 agonists, Zinc and low to moderate amounts of Vitamin D; and d. remeasuring the neurological function of a patient as one measurement to a plurality of measurements over time; e. reassessing the neurological function of a patient as one measurement or a plurality of measurements over time; f. recording the neurological function of a patient from the one to a plurality of measurements; and g. comparing and analyzing the comparison of initial neurological assessment with anyone to a plurality of subsequent measurements or to a control group of measurements.

11. The method of claim 10, wherein antioxidants may include pyrroloquinoline quinone (PQQ), menoquinone4 (Vitamin K2), Vitamin D, DHEA, pregnenolone, progesterone, acetyl-1-carnitine, B Vitamins, melatonin, alpha lipoic acid and/or ubiquinone (CoQ10).

12. The method of claim 10, wherein neurotoxins suppression of glutamate (glutamic acid) or glutamic receptor binding may be decreased by the inclusion of pyrroloquinoline quinone (PQQ), menoquinone4 (Vitamin K2), Vitamin D, DHEA, acetyl-1-carnitine, B Vitamins, melatonin, alpha lipoic acid and/or ubiquinone (CoQ10).

13. The method of claim 10, wherein suppression of pro-inflammatories may be accomplished through the inclusion of pyrroloquinoline quinone (PQQ), menoquinone4 (Vitamin K2), Vitamin D, DHEA, pregnenolone, curcumin, acetyl-1-carnitine, B Vitamins, melatonin, alpha lipoic acid and/or ubiquinone (CoQ10).

14. The method of claim 10, wherein the repair phase, cell-to-cell communication at the membrane lipid rafts and raft-associated growth factor receptor function is supported by inclusion of exogenous cholesterol, phosphatidyl serine, phosphatidyl ethanolamine, phosphatidyl choline and/or phosphatidyl inositol.

15. The method of claim 10, wherein sigma-1 agonists potentiate neurogenesis wherein DHEA, pregnenolone, progesterone and/or allopregnanolone are included to enhance the maintaining of proper cholesterol levels.

16. The method of claim 10, wherein neuroprotectants and neuroregenerators, DHEA and pregnenolone, as well as CoQ10, acetyl-1-carnitine, alpha lipoic acid, melatonin, zinc and low to moderate amounts of Vitamin D are included together with Vitamin A and Vitamin K2 to work symbiotically in neuronal protection and neurogeneration.

17. The method of claim 10, wherein zinc is included for the enhancement of neurogenesis, cell-to-cell communication and GABA synthesis.

18. The method of claim 10, wherein cholesterol must be present with phosphatidyl serine and the other phospholipids to repair and generate membranes.

19. The method of claim 10, wherein phosphatidyl serine and the other phospholipids may be present together to make the membrane Sigma 1 receptor labile for neurosteroids DHEA and pregnenolone to bind, resulting in neurogenesis.

20. The method of claim 10, wherein free radical scavengers may include melatonin, ubiquinone, alpha lipoic acid, acetyl carnitine, and vitamin K2 simultaneously to preserve and augment mitochondrial function.

21. The method of claim 10, wherein CoQ-10, alpha lipoic acid, acetyl carnitine, K2, vitamin D, PQQ, melatonin and zinc may all be present concomitantly to generate new mitochondria (mitochondrial biogenesis), increase the number of Sigma 1 receptors and/or stimulate production of brain derived nerve growth factor (BDNF).

22. The method of claim 10, wherein PQQ and vitamin D and neurosteroids, DHEA and pregnenolone, may be present in conjunction to block the cytokine and interleukin inflammatory responses at their respective sites of initiation and propagation.

23. The method of claim 10, wherein Vitamin A, K2 and D may be simultaneously present together to form a heterodimer which binds to the DNA in the nucleus of cells and initiates mRNA coding and cellular function and repair.

24. The method of claim 10, wherein Vitamin D blocks Ca++ influx at the NMDA receptor, preventing depolarization, while PQQ, DHEA, methylcobalamin and methylfolate, and alpha lipoic acid decrease glutamate excitotoxicity.

25. The method of claim 10, wherein melatonin may be incorporated to block the glutamate receptor.

26. The method of claim 10, wherein Vitamin A and Vitamin D are included together for their augmented neuroprotective capacity.

27. The method of claim 10, wherein methylfolate and methylcobalamin are included together to sustain optimal vitamin D binding protein levels.

28. The method of claim 10, wherein the formulation of claim 5 protects the individual from detrimental effects of concussions, regenerates the neuronal network after such injury, or a combination thereof and/or protects the individual's myocardium after ischemic reperfusion.

29. The method of claim 10, wherein the individual benefitting from the administration of the formulation of claim 5 may be one who is suffering from Alzheimer's, Dementia, Parkinson's disease, ALS, strokes (both hemorrhagic and ischemic), spinal cord injury, concussion, autism, multiple sclerosis, ADHD, neurodegenerative disease, Guillain-Barre syndrome, or traumatic brain injury.

Description

DESCRIPTION OF PREFERRED EMBODIMENTS

[0049] The purpose of the invention is to provide a dietary supplement and a therapy comprising the use of this dietary supplement for individuals suffering from diseases, disorders, dysfunctions or injuries including, but not limited to, Alzheimer's disease, Parkinson's disease, ALS, dementia, stroke (both hemorrhagic and ischemic), spinal cord injury, concussion, autism, multiple sclerosis, ADHD, neurodegenerative disease, Guillain-Barre syndrome, or traumatic brain injury.

[0050] The present invention discloses a dietary supplement and a multifactorial therapy method utilizing the present invention that is this dietary supplement to treat this highly complex multivariate system. Such a dietary supplement comprises all of the necessary ingredients for neurological protection and neuroregeneration in one formulation. For instance, the therapy comprising the dietary supplement described herein scavenges free radicals resulting from injuries, whether gradual or sudden, invokes protective gene expression, and protects healthy cells from neurotoxins released from damaged neurons or glia by numerous mechanisms including but not limited to blocking the release of neurotoxins and blocking the receptors for neurotoxins. Additionally, this therapy suppresses inflammatory responses resulting from the injury or process by decreasing the level of pro-inflammatory cytokines. Finally, the therapy initiates the repair process by enhancing cell to cell communication at the membrane lipid rafts, promotes neurogenesis and neurite outgrowth, and/or a combination of the above thereof.

[0051] In a preferred embodiment, the present invention provides a dietary supplement that comprises a combination of vitamins, minerals and neuroprotective and neurogenerative substances that are naturally endogenous to the brain (yet, often resultantly deficient, unavailable, in some way stymied or simply in insufficient quantities due to disease, age or injury) which are, nonetheless essential for membrane structure, necessary for mitochondrial regeneration, and are crucial in directing stem cell differentiation toward neurogenesis and myelogenesis.

[0052] In one embodiment, the ingredients in the dietary supplement comprises a mixture of the following ingredients including but not limited to cholesterol, an acidity flavor blocker (also referred to as an acid blocker), coenzyme Q10 or CoQ10, Acetyl L-Carnitine, rice extract from rice bran (e.g. Nu-RICE), Vitamin C, Lipoic Acid or alpha lipoic acid, sugar substitute (e.g. Stevia), zinc picolinate, pregnenolone, folic acid or its derivative, for instance, Quatrefolic, Vitamin B12 or methyl Vitamin B12, Pyrroloquinoline Quinone (PQQ), Vitamin D3, Vitamin K2, curcumin, phosphatidyl serine, phosphatidyl choline, phosphatidylethanolamine, phosphatidyl inositol, huperizine, gamma-aminobutyric acid (GABA) and flavor (for instance, fruit punch), or a combination thereof.

[0053] In another preferred embodiment, the ingredients in the dietary supplement comprises a mixture of the following ingredients including but not limited to cholesterol, an acidity flavor blocker (also known as an acid blocker), coenzyme Q10 or CoQ10, Acetyl L-Carnitine, rice extract from rice bran (e.g. Nu-RICE), Vitamin C, Lipoic Acid or alpha lipoic acid, sugar substitute (e.g. Stevia), zinc picolinate, pregnenolone, folic acid or its derivative, for instance, Quatrefolic, Vitamin B12 or methyl Vitamin B12, Pyrroloquinoline Quinone (PQQ), Vitamin D3, Vitamin K2, curcumin, phosphatidyl serine, phosphatidyl choline, phosphatidylethanolamine, phosphatidyl inositol, huperizine, gamma-aminobutyric acid (GABA), L-carnitine and flavor (for instance, fruit punch) or a combination thereof.

[0054] In certain embodiments, the dietary supplement may comprise a derivative, an analog, an active isomer or a metabolite of these ingredients or a combination thereof. For instance, it may include cholesterol, or a derivative, an analog, or an active isomer of cholesterol or a combination thereof. It may include CoQ10, or a derivative, an analog, or an active isomer of CoQ10 or a combination thereof. It may include L-Carnitine, or a derivative of L-Carnitine including but not limited to acetyl L-Carnitine, an analog, or an active isomer of L-Carnitine or a combination thereof.

[0055] The Vitamin C in the dietary supplement may, for example, be in the form of ascorbic acid. In certain embodiments, the dietary supplement of the present invention may include a derivative of vitamin C including but not limited to one or more salts of ascorbic acid, an analog of vitamin C or a combination thereof. Examples include, but are not limited to calcium ascorbate, sodium ascorbate, and other mineral ascorbates; ascorbic acid with bioflavonoids; and combination products, such as Ester-C, which contains calcium ascorbate, dehydroascorbate, calcium threonate, xylonate, and lyxonate.

[0056] The dietary supplement may include lipoic acid, or a derivative of lipoic acid including but not limited to alpha lipoic acid, an analog, or an active isomer of lipoic acid or a combination thereof. The dietary supplement may include a sugar substitute, including but not limited to Stevia, a derivative, an analog or an active isomer of the sugar substitute or a combination thereof. It may include dehydroepiandrosterone, a derivative, an analog or an active isomer of dehydroepiandrosterone or a combination thereof. It may include picolinate, a derivative of picolinate including but not limited to zinc picolinate, an analog or an active isomer of picolinate or a combination thereof. It may include pregnenolone, or a derivative, an analog or an active isomer of pregnenolone or a combination thereof. It may include folic acid, a derivative of folic acid including but not limited to quatrefolic, an analog or an active isomer of folic acid or a combination thereof.

[0057] It may include cobalamin, a derivative of cobalamin including but not limited to methylcobalamin, adenosylcobalamin, hydroxycobalamin, an analog of cobalamin, or a combination thereof. It may include Pyrroloquinoline Quinone, a derivative, an analog or an active isomer of pyrroloquinoline quinone or a combination thereof. It may include vitamin D, or a derivative of vitamin D including but not limited to vitamin D3 or cholecalciferol, an analog or an active isomer of vitamin D3 or a combination thereof. It may include vitamin K, or a derivative of vitamin K including but not limited to menaquinone or vitamin K2, an analog or an active isomer of vitamin K or a combination thereof. It may include curcumin, or a derivative, an analog or an active isomer of curcumin or a combination thereof. It may include serine, or a derivative of serine including but not limited to phosphatidyl serine, an analog or an active isomer of serine or a combination thereof. It may include choline, or a derivative of choline including but not limited to phosphatidyl choline, an analog or an active isomer of choline or a combination thereof. It may include inositol, or a derivative of inositol including but not limited to phosphatidyl inositol, an analog or an active isomer of inositol or a combination thereof. It may include ethanolamine, or a derivative of ethanolamine including but not limited to phosphatidyl ethanolamine, an analog or an active isomer of ethanolamine or a combination thereof. Further, it may include a derivative, analog, isomer or some natural or synthetic variation of Vitamin A, huperizine, or GABA as warranted by specific requirements and functions of the above neuro-therapeutic formulation.

[0058] In another embodiment, the dietary supplement may comprise the abovementioned ingredients in the pure, substantially pure or synthetic form, as determined by any suitable method for determination of purity that is well accepted and established.

[0059] In yet another embodiment, the representative dietary supplement may comprise about 75 mg to about 4000 mg of cholesterol, about 50 mg to about 3000 mg of Fruit Punch Flavor, about 20 mg to about 5000 mg of Acidity Flavor Blocker, about 10 mg to about 5000 mg of coenzyme Q10 or CoQ10, about 10 mg to about 5000 mg of Acetyl L-Carnitine, about 10 mg to about 5000 mg of Rice Extract, about 20 mg to about 10000 mg of Vitamin C, about 15 mg to about 2000 mg of Lipoic Acid or alpha lipoic acid, about 10 mg to about 700 mg of sugar substitute, for instance, Stevia 90%, about 50 mcg to about 150 mcg of Huperizine, about 1 mg to about 500 mg of zinc picolinate, about 1 mg to about 1000 mg of pregnenolone, about 150 mg to about 2000 mg of gamma-aminobutyric acid (GABA), about 0.1 mg to about 200 mg of folic acid or its derivative, for instance, Quatrefolic, about 0.1 mg to about 200 mg of Vitamin B12 or methyl Vitamin B12, about 0.1 mg to about 200 mg of Pyrroloquinoline Quinone, about 1 mcg to about 500 mg of Vitamin D3, about 1 mcg to about 5 mg of Vitamin K2, about 2500 IU to 10,000 IU of Vitamin A, about 10 mg to about 5000 mg of curcumin, about 10 mg to about 700 mg of phosphatidyl serine, about 1 mg to about 1000 mg of phosphatidyl choline, about 0.5 mg to about 200 mg of phosphatidyl inositol, and about 1 mg to about 1000 mg of phosphatidylethanolamine.

[0060] The above preferred embodiments may or may not include DHEA (dehydroepiandrosterone), also commonly referred to as androstenolone, as an adjunct and addition to the previously described formulation as this substance, which is a steroid hormone naturally produced in the adrenal glands of the human body and is the most abundant hormone in the blood stream, it is nonetheless a prohibited substance under the World Anti-Doping Code of the World Anti-Doping Agency (WADA), which manages drug testing for Olympics and other sports. The inclusion of this ingredient is therefore unwarranted in products that would be consumed by competitive athletes. It is equally not recommended in pediatric or adolescent populations.

[0061] The above preferred embodiments may be further augmented through the inclusion of naturally occurring cannabinoids derived from the hemp plant (Cannabis sativa), namely cannabidiol (CBD), or one of over 100 active phytocannabinoids. CBD is a preferred, non-psychoactive compound that interacts with the endocannabinoid system, through cannabinoid receptors, to potentiate the alleviation of the symptoms of various debilitating conditions including several neurodegenerative diseases, seizure disorders, mood disorders, and muscular and inflammatory conditions and has been studied most predominantly. Specifically, CBD has gained orphan status in the United States for the treatment of Dravet's syndrome and has been approved for the treatment of Multiple Sclerosis in the United Kingdom and Sweden. Yet, as research broadens in light of further research into cannabinoids, other phytocannabinoids, or their natural or synthetic derivatives, may as well be incorporated into the above proposed formulation. Too, though, CBD is a prohibited substance under the World Anti-Doping Code of the World Anti-Doping Agency (WADA), and as such is precluded from use by competitive athletes and may be conspicuously absent from formulations geared toward consumption by athletes.

[0062] The above preferred embodiments may include an additional supplement of Curcumin. A review of the unparalleled suppression of all inflammatory cytokines by curcumin can be reviewed elsewhere. Curcumin may be included in the present invention for that purpose of inflammatory cytokine suppression with an added benefit as a potent free radical scavenger/antioxidant.

[0063] A representative formulation of the dietary supplement, shown in TABLE 9 and TABLE 10, depicts representative concentrations per packet representing a once daily dose for each of the ingredient combination examples of 2 variations of the present invention. Further TABLE 10 shows milligram strengths (per packet) and optimal ranges of each ingredient of another variation of the present invention. Although these are two examples of the ingredients in a representative, preferred formulation with the representative forms and representative dosages per serving, the present invention broadly encompasses other formulations that have variations in the types of ingredients, forms and dosages per serving. Namely, certain ingredients may be patently absent from formulations designed for and administered to competitive athletes (e.g. DHEA and Cannabis) and/or absent melatonin with an acknowledgement toward the high degree of sedation and its capacity to induce drowsiness.

[0064] In still yet another embodiment, the dietary supplement described herein is in a powder form that can be dissolved in water, juice or fruit sauce, where the powder may or may not be flavored. Moreover, the preparation of the formulations of the present invention is not limited to a specific manufacturing process.

[0065] In further yet another embodiment, the powder is administered by means including, but not limited to oral, buccal, sublingual, rectal, transdermal, intravenous, intramuscular, subcutaneous, or intraperitoneal. For instance, in the event that the patient is unable to swallow due to paralysis, the powder can simply be mixed with water and administered through the patient's nasogastric or gastric feeding tube (e.g. NG-tube and PEG, G-button/G-tube respectively).

[0066] In another embodiment, there is a method of treating an individual by administering this dietary supplement to the individual, where the dietary supplement provides neurological protection and regeneration by scavenging free radicals resulting from injuries whether gradual or sudden, increasing gene expression, protecting healthy cells from neurotoxins released from damaged neurons or glia by mechanisms including but not limited to blocking the release of neurotoxins, blocking the receptors for neurotoxins or a combination thereof, suppressing inflammatory responses resulting from the injury or process by decreasing the level of pro-inflammatory cytokines, enhancing cell to cell communication at the membrane lipid rafts, and promoting neurogenesis, promoting neurite outgrowth, or a combination thereof. In yet another embodiment, the inflammatory cytokines include but are not limited to IL-1, IL-1, IL-6, and TNF-alpha.

[0067] In still yet another embodiment, the dietary supplement protects the individual from detrimental effects of concussions, regenerates the neuronal network after such injury, or a combination thereof and/or protects the individual's myocardium after ischemic reperfusion. In further yet another embodiment, the individual benefitting from the administration of this dietary supplement may be one who is suffering from Alzheimer's, Dementia, Parkinson's disease, ALS, strokes (both hemorrhagic and ischemic), spinal cord injury, concussion, autism, multiple sclerosis, ADHD, neurodegenerative disease, Guillain-Barre syndrome, or traumatic brain injury.

[0068] It is to be understood that the dietary supplement of the present invention can also be prepared and administered with any pharmaceutically acceptable carrier or carriers. Moreover, a dietary supplement of the present invention can also be prepared in such a manner that the formulation comprises one or more pharmaceutically acceptable excipients. Examples of some of the various classes or types of excipients that may be used in preparation of the dietary supplement include, but are not limited to, flavoring agents, coloring agents, stabilizing agents, binders, disintegrants, and other well-accepted types of excipients that are safe and effective for human use and consumption. Because it is well understood that the number and type of specific excipients is too exhaustive and numerous to be listed here, it is to be understood that the inventors of the present invention have contemplated that the dietary supplement of the present invention may comprise any suitable combination of one or more pharmaceutically acceptable excipients, for instance, for preparation and manufacturing of the dietary supplement. Such representative excipients that may be used for preparation of the dietary supplement (for instance, for preparation of a suitable dosage form for administration of a dietary supplement) may include, but are not limited to, one or more of the pharmaceutically acceptable excipients disclosed in the Handbook of Pharmaceutical Excipients (sixth edition; edited by Rowe, Sheskey and Quinn), which is herein incorporated by reference.

[0069] The foregoing descriptions of the embodiments of the present invention have been presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the present invention to the precise forms disclosed. The exemplary embodiments were chosen and described in order to best explain the principles of the present invention and its practical application, to thereby enable others skilled in the art to best utilize the present invention.

TABLE-US-00012 TABLE 9 Per 30 60 90 120 Packet Packets Packets Packets Packets Grams Cholesterol 1.5 45 90 135 180 Fruit Punch Flavor 1.5 45 90 135 180 Acid Blocker 1 30 60 90 120 CoQ-10 1 30 60 90 120 Acetyl L-Carnitine 1 30 60 90 120 GABA 1 30 60 90 120 NuRice 0.75 22.5 45 67.5 90 Curcumin 0.6 18 36 54 72 Vitamin C 0.5 15 30 45 60 Apha Lipoic Acid 0.4 12 24 36 48 Stevia 0.175 5.25 10.5 15.75 21 DHEA 0.025 0.75 1.5 2.25 3 Zinc Piccolinate 0.02 0.6 1.2 1.8 2.4 Pregnenolone 0.02 0.6 1.2 1.8 2.4 Melatonin 0.006 0.18 0.36 0.54 0.72 Quatrefolic 0.006 0.18 0.36 0.54 0.72 Methyl B12 0.003 0.09 0.18 0.27 0.36 Phosphatidyl Serene 0.128 3.84 7.68 11.52 15.36 PQQ 0.02 0.6 1.2 1.8 2.4 Vitamin D3 1% 0.05 1.5 3 4.5 6 Vitamin K2 2500 ppm 0.04 1.2 2.4 3.6 4.8 Total Pack Weight 9.743

TABLE-US-00013 TABLE 10 NEUPANEX Per 30 60 90 120 Grams Cholesterol 1.5 45 90 135 180 Fruit Punch 1.5 45 90 135 180 Acid Blocker 1 30 60 90 120 CoQ-10 1 30 60 90 120 Acetyl L-Carnitine 1 30 60 90 120 GABA 1 30 60 90 120 NuRice 0.75 22.5 45 67.5 90 Curcumin 0.6 18 36 54 72 Vitamin C 0.5 15 30 45 60 Apha Lipoic Acid 0.4 12 24 36 48 Stevia 0.175 5.25 10.5 15.75 21 DHEA 0.025 0.75 1.5 2.25 3 Zinc Piccolinate 0.02 0.6 1.2 1.8 2.4 Pregnenolone 0.02 0.6 1.2 1.8 2.4 Melatonin 0.006 0.18 0.36 0.54 0.72 Quatrefolic 0.006 0.18 0.36 0.54 0.72 Methyl B12 0.003 0.09 0.18 0.27 0.36 Phosphatidyl 0.128 3.84 7.68 11.52 15.36 PQQ 0.02 0.6 1.2 1.8 2.4 Vitamin D3 1% 0.05 1.5 3 4.5 6 Vitamin K2 0.04 1.2 2.4 3.6 4.8 Total Pack Weight 9.743

TABLE-US-00014 TABLE 11 Per Packet Ingredient Concentration Range Cholesterol NF 15 g 75 mg-4000 mg Fruit Punch Flavor 15 g 50 mg-3000 mg Acidity Flavor Blocker 1 g 20 mg-5000 mg CoQ-10 1 g 10 mg-5000 mg Acetyl L-Carnitine 1 g 10 mg-5000 mg NuRice 750 mg 10 mg-5000 mg Vitamin C 500 mg 20 mg-10000 mg Apha Lipoic Acid 400 mg 15 mg-2000 mg Stevia 90% 175 mg 10 mg-700 mg Huperizine A 100 mcg 50 mcg-200 mcg Zinc Piccolinate 20 mg 1 mg-500 mg Pregnenolone 20 mg 1 mg-1000 mg GABA (gamma-aminobutyric 1000 mg 250 mg-1500 mg acid) Methyl Folate 6 mg .1 mg-200 mg Methyl B12 3 mg .1 mg-200 mg PQQ (Pyrroloquinoline 20 mg .1 mg-200 mg quinone) Vitamin D3 125 mcg 1 mcg-5 mg.sup. Vitamin K2 mk4 3 mcg 1 mcg-5 mg.sup. Vitamin A (palmitate) 5000 IU 2500 IU-10,000 IU Curcumin 600 mg 10 mg-5000 mg Phosphatidyl Serene Complex phosphatidylserine 100 mg 10 mg-700 mg phosphatidylcholine 25 mg 1 mg-1000 mg phosphatidylethanolamine 2.5 mg 1 mg-1000 mg phosphatidylinositol 1.5 mg .5 mg-200 mg