DIETARY SUPPLEMENT COMPOSITIONS FOR TREATING NEUROLOGICAL DISORDERS, AND METHODS OF TREATING NEUROLOGICAL DISORDERS USING SAME
20200390138 ยท 2020-12-17
Inventors
Cpc classification
A23V2002/00
HUMAN NECESSITIES
A61P43/00
HUMAN NECESSITIES
A61K9/0053
HUMAN NECESSITIES
A61K2300/00
HUMAN NECESSITIES
A61K2300/00
HUMAN NECESSITIES
A61K36/45
HUMAN NECESSITIES
A23L33/105
HUMAN NECESSITIES
A61K45/06
HUMAN NECESSITIES
A61K31/357
HUMAN NECESSITIES
A61K31/122
HUMAN NECESSITIES
A23V2200/322
HUMAN NECESSITIES
A61P25/28
HUMAN NECESSITIES
A61K31/352
HUMAN NECESSITIES
A61K31/122
HUMAN NECESSITIES
A61K36/45
HUMAN NECESSITIES
A61K31/714
HUMAN NECESSITIES
International classification
A23L33/105
HUMAN NECESSITIES
A61K31/122
HUMAN NECESSITIES
A61K31/714
HUMAN NECESSITIES
A61K45/06
HUMAN NECESSITIES
A61K9/00
HUMAN NECESSITIES
A61P25/28
HUMAN NECESSITIES
Abstract
A dietary supplement composition, which may be used for treating neurological and developmental disorders in human subjects, includes trans-resveratrol, ginkgo biloba, Coenzyme Q10, and natural flavonoids blend, in which a content of the trans-resveratrol is about 250 mg; a content of the ginkgo biloba is about 120 mg; a content of the Coenzyme Q10 is about 100 mg; and a content of the natural flavonoids blend is about 256 mg. The natural flavonoids blend may include quercetin, fisetin derived from strawberries; and anthocyanidin and anthocyanin derived from European blueberry extracts. The dietary supplement composition according another aspect includes at least three of trans-resveratrol, ginkgo biloba, Coenzyme Q10, and natural flavonoids blend. The dietary supplement compositions further includes zinc gluconate, cyanocbalamin and taurine. Such dietary supplement compositions are effective and efficient for treating subjects having neurological disorders including autism spectrum disorders, and Alzheimer's disease.
Claims
1. A dietary supplement composition comprising trans-resveratrol; ginkgo biloba; Coenzyme Q10; and natural flavonoids blend.
2. A dietary supplement composition according to claim 1, wherein a content of said trans-resveratrol is about 250 mg; a content of said ginkgo biloba is about 120 mg; a content of said Coenzyme Q10 is about 100 mg; and a content of said natural flavonoids blend is about 256 mg.
3. A dietary supplement composition according to claim 1, further comprising zinc gluconate, cyanocbalamin and taurine.
4. A dietary supplement composition according to claim 3, wherein a content of zinc gluconate is about 10 mg; a content of cyanocbalamin is about 0.25 mg and a content of taurine is about 500 mg.
5. A dietary supplement composition according to claim 1, wherein said natural flavonoids blend includes quercetin, fisetin derived from strawberries; and anthocyanidin and anthocyanin derived from European blueberry extracts.
6. A dietary supplement composition according to claim 1, wherein said composition is provided in a formulation selected from the group consisting of a capsule, a powder, a tablet, a liquid, an emulsion, a beverage and a functional food.
7. A dietary supplement composition comprising at least three of: trans-resveratrol; ginkgo biloba; Coenzyme Q10; and natural flavonoids blend.
8. A dietary supplement composition according to claim 7, wherein when present: a content of said trans-resveratrol is about 250 mg; a content of said ginkgo biloba is about 120 mg; a content of said Coenzyme Q10 is about 100 mg; and a content of said natural flavonoids blend is about 256 mg.
9. A dietary supplement composition according to claim 7, further comprising zinc gluconate, cyanocbalamin and taurine.
10. A dietary supplement composition according to claim 9, wherein a content of zinc gluconate is about 10 mg; a content of cyanocbalamin is about 0.25 mg and a content of taurine is about 500 mg.
11. A dietary supplement composition according to claim 7, wherein said composition is provided in a formulation selected from the group consisting of a capsule, a powder, a tablet, a liquid, an emulsion, a beverage and a functional food.
12. A method of treating a neurological disorder in a subject, said method comprising: selecting a subject in need of treatment of the neurological disorder, and administering a dietary supplement composition to said subject; said dietary supplement composition comprising trans-resveratrol, ginkgo biloba, Coenzyme Q10, and natural flavonoids blend.
13. A method of treating a neurological disorder in a subject according to claim 12, wherein said neurological disorder is an autism spectrum disorder.
14. A method of treating a neurological disorder in a subject according to claim 12, wherein said neurological disorder is an Alzhemer's disease.
15. A method of treating a neurological disorder in a subject according to claim 12, wherein in said dietary supplement composition, a content of said trans-resveratrol is about 250 mg; a content of said ginkgo biloba is about 120 mg; a content of said Coenzyme Q10 is about 100 mg; and a content of said natural flavonoids blend is about 256 mg.
16. A method of treating a neurological disorder in a subject according to claim 12, wherein said dietary supplement composition further comprises zinc gluconate, cyanocbalamin and taurine.
17. A method of treating a neurological disorder in a subject according to claim 12, wherein said natural flavonoids blend includes quercetin, fisetin derived from strawberries; and anthocyanidin and anthocyanin derived from European blueberry extracts.
18. A method of treating a neurological disorder in a subject according to claim 12, wherein said dietary supplement composition is provided in a formulation selected from the group consisting of a capsule, a powder, a tablet, a liquid, an emulsion, a beverage and a functional food.
19. A method of treating a neurological disorder in a subject according to claim 18, wherein said administering a dietary supplement composition includes said subject ingesting said dietary supplement composition once a day.
Description
DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS OF THE INVENTION
[0034] Various aspects of the dietary supplement compositions for repairing, restoring and/or rejuvenating the damaged and impaired neurons in neurological disorders, e.g., for subjects of ASD and Alzheimer's disease are discussed below.
A. Four Concepts and Aspects to Repair Damaged or Impaired Neurons
[0035] Repair of damaged neurons with autism was considered based on four concepts and aspects: (1) regeneration and remodeling, (2) improving cognitive function and memory, (3) providing energy, and (4) providing antioxidants against cell damages.
1. Regeneration and Remodeling
[0036] There are various dietary supplement ingredients for regeneration and remodeling of neurons.
1-1. Polyphenol
[0037] One of the polyphenols that may used in dietary supplement of the present invention is Trans-resveratrol (3,5,4-trihydroxy-trans-stilbene). It is generally used as a dietary supplement. Trans-resveratrol has been used for extension of life-span of humans. It is a stilbenoid, a type of natural polyphenol found in several plants, and produced in response to injury or infections. One may get resveratrol by consuming of grapes and red wine. The resveratrol in red wine comes from the skin of grapes used to make wine.
[0038] Another polyphenol which may be used in dietary supplement of the present invention is Pterostilbene, which is an analogue of trans-resveratrol. It is a stilbenoid chemically related to resveratrol, and it serves a defensive phytoalexin role in plants.
[0039] Phlorizin (phloretin-2--D-glucopyranoside) found from apple fruits, is a phytochemical that belongs to the class of polyphenols. Phlorizin is a glucoside of phloretin mainly found in the leaves of apple trees. Both of phlorizin and phloretin have bioactivity.
1-2. Vitamin and Amino Acids
[0040] Cyanocbalamin is a type of vitamin B12 helpful for the purpose of regeneration of neurons. Also, amino acids, L-taurine, acetyl-L-carnitine and L-tryptophan are candidates for the purpose of regeneration of neurons.
1-3. Fatty Acid and Membrane Stabilizer
[0041] DHA (docosahexaenoic acid), a fatty acids is a component of omega-3 fats. These fats are generally found in fish oils and seafood, with small amounts of DHA found in algae. DHA is a building block of tissue in the brain and helps with forming neural transmitters such as phosphatidylserine which is important for brain function. Children require DHA for growth and development of their bodies. The brain, central nervous system (CNS) and retina rely heavily on the adequate supply of DHA during growth.
[0042] Phosphatidylserine (PS) an essential component of healthy cell membranes, is critical to brain metabolism and function, and supports brain-cell-to-brain-cell connections. It is well recognized that 2-dimethylaminoethanol (DMAE) stabilizes cell membranes. Cell membrane degradation has been proposed as one of the prime mechanisms of dysfunction of cells. DMAE may be used in the compositions of the present invention.
1-4. Minerals
[0043] Mineral ions play important role in the bioprocess for regeneration and remodeling. Zinc ion is used in many reactions. Zinc gluconate is an efficient form of the supplement.
1-5. Peptide-Type Growth Factors
[0044] Nerve growth factor (NGF) is a neurotrophic factor and neuropeptide primarily involved in the regulation of growth, maintenance, proliferation, regeneration of neurons. Although, NGF and other peptide types of neuron growth factors may not be considered as dietary supplements, NGF and other peptide types of neuron growth factors may be considered for this purpose in the present invention.
2. Improving Cognitive Function and Memory
[0045] 2-1. Dietary Supplements from Traditional Medicines
[0046] Ginkgo biloba, which is derived from ginkgo tree, is native to China. Most of ginkgo trees in China are over 1000 years old. It is one of oldest survived plant species. Ginkgo biloba has been effectively used by ancient Chinese in treating neurological disorders. It is believed that it may improve cognitive function and memories.
[0047] Ashwagandha, a traditional Indian ginseng, has beneficial effects on mood and helps the body to adapt to stress to promote well-being. It promotes the healthy growth of axons and dendrites, nerve cell components. Ashwagandha also inhibits an enzyme that breaks down acetylcholine, which helps to maintain cognition and memory.
2-2. Phospholipid
[0048] Phosphatidylcholine (PC) is a class of phospholipids that incorporate choline as a headgroup. Phosphatidylcholine exists naturally in the body in all cells. It was found in eggs, soybeans, mustard, sunflower, and other foods. The term phosphatidylcholine is sometimes used interchangeably with lecithin. Egg yolk lecithin and soybean lecithin are helpful for improving cognitive function and memories.
2-3. Amino Acids
[0049] Amino acids, specifically, L-phenylalanine and L-arginine are helpful for improving memory in humans. L-tryptophan is an amino acid that is important for the production of serotonin. The conditionally essential amino acid L-tyrosine is a precursor of catecholamine neurotransmitters, including dopamine. L-Theanine is helpful for increasing serotonin and dopamine. Both of serotonin and dopamine are important molecules promoting well-being and beneficial memories.
2-4. Vitamin B9 and Methylation
[0050] Methylation processes are important and essential for all cells in human body. Folic acid is a vitamin type of methyl group donor. Folic acid is vitamin B9 that is often generally added to processed foods and used in dietary supplements.
[0051] S-adenosyl-L-methionine (SAMe) is an universal methyl group donor in the cell. In some countries, SAMe is prescription drug, which is used for anti-depression. In United States and Europe, SAMe is a dietary supplement, SAMe is useful for the purpose of this invention. SAMe helps regulate mood and well-being.
2-5. Additional Ingredients
[0052] Uridine-5-monophosphate (UMP) supports healthy brain function. UMP has been shown to promote healthy levels of neurotransmitters acetylcholine and dopamine, which supports well-being and memory.
3. Providing Energy
3-1. Molecule in the Chain of Electron Transport
[0053] Coenzyme Q10 (CoQ10) also known as ubiquinone, ubidecarenone, or coenzyme Q, is a coenzyme that is ubiquitous in animals and most bacteria, and it is necessary for the production of energy.
[0054] Nicotinamide adenine dinucleotide (NAD) is a cofactor found in all living cells. NAD, and its precursors such as niacin (NA), nicotinamide (NAM), nicotinamide riboside (NR), nicotinamide mononucleotide (NMN), are all useful for the purpose of increasing energy.
3-2. Energy
[0055] Adenosine triphosphate (ATP) is the direct energy for driving and functioning of many processes of brain. It is generally used as the dietary supplement.
3-3. Molecule making ATP
[0056] D-Ribose is a molecule that makes ATP.
[0057] 3-4 Stimulating ATP production using traditional medicine
[0058] In Tibet, Rhodiola is a traditional medicine, which is used for the purpose of increasing mental performance, brain function. Rhodiola is also used as a dietary supplement. Rhodiola stimulates ATP production.
4. Antioxidants Against Cell Damages
4-1. Flavonoids
[0059] The general structure of flavonoids has 15-carbon skeleton, which consists of two phenyl rings and a heterocyclic ring. This unique structure enables flavonoids to exhibit antioxidant bioactivity.
[0060] Flavonoids such as quercetin, fisetin (from strawberry), anthocyanidin and anthocyanin (European blueberry extracts), are useful for the purpose to protect damaged cells with autism.
4-2. Carotenoid
[0061] Astaxanthin, a xanthophyll carotenoid, present in microalgae, fungi, complex plants, seafood, flamingos and quail. It is a powerful antioxidant prevents and/or minimizes damage to cells.
4-3. Amino Acids
[0062] Amino acids, such as N-acetyl-L-cysteine and glutathione (GSH) protect neurons. GSH, a tripeptide formed from three amino acids, is an antioxidant in plants, animals, fungi, and some bacteria and archaea.
B. Dietary Supplement Compositions Formulations
[0063] Formula I of the dietary supplement composition of the present invention consists of following molecules selected from above pool of four aspects described above. In other words, the dietary supplement composition according to Formula I includes trans-resveratrol; ginkgo biloba; Coenzyme Q10; and natural flavonoids blend. Detailed amounts of each compound are provided in Example 1 herein.
Part 1. Trans-Resveratrol
[0064] In the present formulation, trans-resveratrol may function as regeneration and remodeling. About 20 years ago, the inventor of the present invention found that trans-resveratrol could help the stem cells transforming into neuron cells. In addition, trans-resveratrol is one of the most relevant and extensively studied polyphenol. Accordingly, in the dietary supplement composition of the present invention, trans-resveratrol was chosen from the pool of molecules in the aspect Regeneration remodeling. Chemical structure of trans-resveratrol is illustrated in the following Illustration 1.
##STR00001##
[0065] Trans-resveratrol is a dietary supplement, and has been used for a long time, which proved that it is safe for human consumption. It is natural and isolated from Japanese knotweed.
[0066] However, one or more of polyphenols. such as Pterostilbene, Phlorizin, phloretin etc., may be used in combination with Trans-resveratrol or separately.
Part 2. Ginkgo Biloba
[0067] Ginkgo biloba is the extract from the dried leaves of ginkgo tree. More specifically, the registry CAS number for ginkgo biloba is 90045-36-6 designated by the Chemical Abstracts Service (CAS). Ginkgo biloba was chosen by the present inventor as one component of the combination for the treatment of autism from the pool of possible materials mostly for the aspect of improving cognitive function and memory.
[0068] However, one or more other components for improving cognitive function and memory aspects discussed above, such as Ashwagandha, Phosphatidylcholine (PC), amino acids including L-phenylalanine and L-arginine, vitamin B9 and methylation, S-adenosyl-L-methionine (SAMe), Uridine-5-monophosphate (UMP) may be used in combination with Ginkgo biloba or separately.
Part 3. CoQ10
[0069] CoQ10, a known dietary supplement, has been used to improve cardiologic function. In the present invention, CoQ10 was chosen by the present inventor as one component of the combination for the treatment of autism from the pool of molecules for achieving the aspect providing energy. The representative chemical structure of CoQ10 used in the formulation of the present dietary supplement composition is illustrated below in Illustration 2.
##STR00002##
[0070] However, one or more energy providing aspects discussed above, such as NAD, NA, NAM, NR, NMN, ATP, D-Ribose, Rhodiola may be used in combination with CoQ10 or separately.
Part 4. Flavonoids Blend
[0071] A blend of flavonoids quercetin, fisetin (from strawberry), anthocyanidin and anthocyanin (European blueberry extracts), were chosen as a part of the combination for the treatment of autism in this patent in the aspect Antioxidants against cell damages. Anthocyanin is anthocyanidin-glucoside. The chemical structures of quercetin, fisetin, and anthocyanidin are illustrated in Illustration 3, Illustration 4 and Illustration 5, respectively.
##STR00003##
where,
R.SUP.3.=OH
[0072] R.sup.5=OH or OCH.sub.3
R.SUP.6.=H or OH
[0073] R.sup.7=OH or OCH.sub.3
R.sup.3H or OH or OCH.sub.3
R.SUP.4.=OH
[0074] R.sup.5=H or OH or OCH.sub.3.
Modifications of Dietary Supplement Composition Formulations
[0075] Formulas II through V are modifications derived from Formula I. The details of each compound is shown by Example 5.
[0076] Formula VI: Formula VI includes Formula I with addition of followings: Zinc gluconate (for example, see Illustration 6), cyanocbalamin (vitamin B12) (for example, see Illustration 7) and taurine (for example, see Illustration 8), which additional components were chosen from the pool of molecules in the aspect Regeneration remodeling.
##STR00004##
C. Treatments Using Dietary Supplement Compositions
[0077] Before the beginning of the treatment, all children or patients with autism were diagnosed through examination by psychologists or neurologists. Parents provided data about behaviors of their children before and after the treatment, based the following categories: hyperactivity, toys destruction, playing with friends, communication with parents, verbal communication skills, aggression and learning skills. The screening methods were designed by the psychologist specifically for the purposes of this present invention.
1. The First Treatment of a Patient.
[0078] A male patient with autism aged 25 in New Jersey was treated with Formula I from June in 2016 (Example 2). The patient was administered Formula I once a day. The daily dosage included about 250mg trans-resveratrol, about 120 mg ginkgo biloba, about 100 mg CoQ10 and about 256 mg natural flavonoids blend providing 170 mg strawberry flavonoids (quercetin, fisetin) and about 86 mg European blueberry flavonoids(anthocyanidin, anthocyanin).
[0079] Social interest was improved in 17th week (118 days from treatment). Verbal communication skill has been dramatically improved at 19th week (133 days from treatment); he spoke a complete sentence. Previously he could only speak one word by one word. His memory has been significantly improved in 20th week (136 days from treatment). His mother told him the names of 3 items which were located at different places in a room. Then his mother walked him to other room, and asked him to get that 3 items. He did it correctly. He could only get 1 item before treatment.
[0080] Autism patients, usually have no fears of real dangers such as self-harm or death. The sentiment feeling was improved in 23th week (165 days from treatment): he cried when he heard a closed family friend passed away. Previously he never showed sadness on sad things.
[0081] One of the hard events in the life for the family with autism kids is the aggression to their parents. This patient beat on his mother several times yearly before the treatment when he got mad. After treatment in 25th week (177 days from treatment), the patient was able to completely control himself/his emotions when he got mad, and was non-violent toward his mother. His mother has never suffered from his aggression again. He is stable up to date.
[0082] Improved long term memories: Previously the patient got lost several times without parent's attention. His parents went to a shopping mall with him in 26th week (179 days from treatment), he played far away from parents when his parents were shopping, and he could return to his parents without getting lost. The learning skill has been improved in 26th week (181 days from treatment). His mother surprisingly found the patient was reading a church book in the car when his father was driving home from church. Previously he was never interested in reading a book.
[0083] The dosage was increased twice from 27th weeks, there is no side effects observed during two months.
2. A Small Trial for Treatment of Patients Aged 17-26 using Formula I.
[0084] Based on above successful test of the 25 year old male patient, a small trial of treatment was performed. A group of 37 patients with autism aged 17-26 received the treatment of Formula I (Example 3). Among them one patient dropped out of the trial during the process.
[0085] The improving rates of autism by Formula I in the study were surprisingly good, i.e., 80-94% (Table 1). To the knowledge of the present inventor, there is not any patent or publications showed an improvement efficacy rate as high as the present invention.
TABLE-US-00001 TABLE 1 Effect of Formula I on psychological functions and behaviors in patients with autism aged 17-26. Weeks after Treatment Improvement (%) Hyperactivity 17 83 Toys destruction 17 89 Playing with friends 17 83 Communication with parents 20 91 Verbal communication 20 88 Aggression 26 94 Learning skills 26 91 Sleep disorders 26 86
[0086] There is another group of 8 patients with autism aged 17-26 treated with placebo of multivitamins. Of those that took the placebo, there was generally no improvement in any of the discussed characteristics, as only one of the eight patients reported that the communication skills improved.
3. A Small Trial for Treatment of Children Aged 8-16.
[0087] A group of 30 children with autism aged 8-16 were treated with Formula I, except that the dosage was half of the dosage amount of the above trail involving 37 patients (Example 4). There were 3 children who dropped out of this trial during the treatment.
[0088] Another group of 7 children with autism aged 8-16 treated with placebo multivitamins.
[0089] As shown in Table 2, the improvement rates were 91-96% for those who took the Formula I. The behaviors of children with autism were improved quicker than adult patients.
TABLE-US-00002 TABLE 2 Effect of treatment on psychological functions and behaviors in children with autism aged 8-16. Weeks after Treatment Improvement (%) Hyperactivity 10 92 Toys destruction 10 88 Playing with friends 10 96 Communication with parents 12 85 Verbal communication 12 85 Aggression 15 96 Learning skills 15 88 Sleep disorders 15 81
[0090] There is another group of 7 children with autism aged 8-16 treated with placebo of multivitamins. No improvements were observed in any of these children.
4. The Treatment of Children Aged 8-16 with Different Formulations.
[0091] Children with autism aged 8-16 were divided into five groups, ten children in each group (Example 6). Children were treated with different formulations (Example 5).
[0092] The efficacies is 50-60% without trans-resveratrol (Formula II), 50-80% efficacies without ginkgo biloba (Formula III), 50-70% efficacies without CoQ10 (Formula IV), and 60-70% efficacies without flavonoids blend (Formula V), indicating all components are useful and necessary for obtaining high efficacies (Table 3).
[0093] Interestingly, Formula VI, Formula I adding with about 7.5mg zinc gluconate, about 0.25mg cyanocbalamin (vitamin B12) and about 250 mg taurine showed significant improvements 90-100% (Table 3). It was a small trial with 10 children, with almost 100% efficacy.
[0094] Of them, Zinc is a nutrient helping immune system and metabolism function. Zinc also is an activator of cells.
[0095] Taurine is a sulphur-containing amino acid, found in our bodies and the most animals. Taurine is often added to soda and energy drinks.
TABLE-US-00003 TABLE 3 Effect of treatment on psychological functions and behaviors in children with autism aged 8-16 by different formulations. Improvement(%) Verbal communication Aggression Learning skills Formula I 85 96 88 II 60 50 50 III 50 70 80 IV 70 50 50 V 60 60 70 VI 100 100 90
[0096] There was another group of 7 children with autism aged 8-16 treated with placebo of multivitamins. No improvements were observed in any of these patients.
5. The Treatment of Other Neurologic Diseases.
[0097] Six men aged 80-85 with Alzheimer's disease were treated with Formula I. The Formula I was administered once per day. The daily dosage included about 250mg trans-resveratrol, about 120mg ginkgo biloba, about 100mg CoQ10 and about 256mg natural flavonoids blend providing about 170 mg strawberry flavonoids (quercetin, fisetin) and about 86mg European blueberry flavonoids (anthocyanidin, anthocyanin).
[0098] Three of them were improved after 6 months treatments. A man fell off the bed several times a year before treatment. He hasn't fallen off again from the bed after 6 months treatment. Two of the men in this group showed improved memories. The other three men in this group have not shown any remarkable improvements.
[0099] At the same time, a control group of 4 men aged 80-85 with Alzheimer's disease were supplied with placebo multivitamins, and the men in this group showed no improvement in behaviors.
D. EXAMPLES
D-1. Example 1: Formula I
[0100] The dietary supplement composition according Formula I includes:
(1) about 250 mg of trans-resveratrol,
(2) about 120 mg of ginkgo biloba, (3) about 100 mg of CoQ10, and (4) about 256mg of natural flavonoids blend including quercetin, fisetin (Strawberry), anthocyanidin and anthocyanin (European blueberry extracts).
[0101] In other words, dietary supplement composition according to Formula I includes the trans-resveratrol in the amount of about 34 to 35 mass %; the ginkgo biloba in the amount of about 16 to 17 mass %; the Coenzyme Q10 in the amount of about 13 to 14 mass %; and the natural flavonoids blend in the amount of about 35 to 36 mass %. A full dosage form includes a total of about 726 mg of active ingredients including 250 mg of the trans-resveratrol, 120 mg of the ginkgo biloba, 100 mg of CoQ10, and 256 mg of the natural flavonoids blend.
[0102] It will be understood that, in view of a full dosage form of about 726 mg of active ingredients, a half dosage form includes about 363 mg of the active ingredients; and a double dosage form includes about 1452 mg of the active ingredients. A subject may be administered with a full, half or double dosage form, or a suitable dosage form based on subject's physical characteristics such as a height, a body weight, presence of other ailments, and severity of the developmental, neurological disorder.
D-2 Example 2: Treatment of an Autistic Patient with Formula I
[0103] A male patient with autism aged 25 in New Jersey, was treated by Formula I once a day with a meal. Parents provided data about his behavior before and after the treatment each week during the first 6 months, and followed every 6 months. The daily dosage amount was increased twice beginning the 27th week. In other words, the once per day dosage for 27th week thorough 35th week was increased to double the amount the daily dosage until the 27th week.
[0104] The dosage was increased double the amounts at 27th week, and the treatment was ended at 35th week. Daily dosage from 27th to 35th week was about 500 mg trans-resveratrol, about 240 mg ginkgo biloba, about 200 mg CoQ10 and about 512 mg natural flavonoids blend providing about 340 mg strawberry flavonoids (quercetin, fisetin) and about 172 mg European blueberry flavonoids(anthocyanidin, anthocyanin).
D-3. Example 3: A Small Trial for Treatment of Patients Aged 17-26 using Formula I
[0105] A group of 37 patients with autism aged 17-26 were treated with Formula I once a day with a meal. Another group of 8 patients with autism aged 17-26 were treated with placebo of multivitamins.
D-4. Example 4: A Small Trial for Treatment of Kids with Autism Aged 8-16
[0106] A group of 26 kids with autism aged 8-16 were treated with Formula I. The dosage was the half of Example 1 dosage. Another group of 7 kids with autism aged 8-16 were treated with placebo multivitamins.
D-5. Example 5: Variations of Formulations
[0107] Formula II: It is Formula I without trans-resveratrol. In other words, Formula II is a dietary supplement composition which includes ginkgo biloba, Coenzyme Q10, and natural flavonoids blend, in which a content of the ginkgo biloba is about 120 mg; a content of the Coenzyme Q10 is about 100 mg; and a content of the natural flavonoids blend is about 256 mg. It may additionally include about 10 mg of zinc gluconate, about 0.25 mg of cyanocbalamin (vitamin B12) and about 500 mg of taurine.
[0108] Formula III: It is Formula I without ginkgo biloba. In other words, Formula III is a dietary supplement composition which includes trans-resveratrol, Coenzyme Q10, and natural flavonoids blend, in which a content of the trans-resveratrol is about 250 mg; a content of the Coenzyme Q10 is about 100 mg; and a content of the natural flavonoids blend is about 256 mg. It may additionally include about 10 mg of zinc gluconate, about 0.25 mg of cyanocbalamin (vitamin B12) and about 500 mg of taurine.
[0109] Formula IV: It is Formula I without CoQ10. In other words, Formula IV is a dietary supplement composition which includes trans-resveratrol, ginkgo biloba, and natural flavonoids blend, in which a content of the trans-resveratrol is about 250 mg, a content of the ginkgo biloba is about 120 mg; and a content of the natural flavonoids blend is about 256 mg. It may additionally include about 10 mg of zinc gluconate, about 0.25 mg of cyanocbalamin (vitamin B12) and about 500 mg of taurine.
[0110] Formula V: It is Formula I without flavonoids blend. In other words, Formula V is a dietary supplement composition which includes trans-resveratrol, Coenzyme Q10 and ginkgo biloba, in which a content of the trans-resveratrol is about 250 mg, a content of the Coenzyme Q10 is about 100 mg; and a content of the ginkgo biloba is about 120 mg. It may additionally include about 10 mg of zinc gluconate, about 0.25 mg of cyanocbalamin (vitamin B12) and about 500 mg of taurine.
[0111] Formula VI: It is Formula I with addition of 10 mg zinc gluconate, 0.25 mg cyanocbalamin (vitamin B12) and 500 mg taurine.
D-6. Example 6: The Treatment of Children Aged 8-16 using Different Formulations.
[0112] Fifty children with autism were divided to five groups, and treated with Formula II, III, IV, V and VI. The dosages were the half shown at Example 5. Another group of 7 kids with autism aged 8-16 were treated with placebo multivitamins.
D-7. Example 7: The Treatment of Other Neurologic Diseases
[0113] Six men aged 80-85 with Alzheimer's disease were treated with Formula I. Three of six men were shown improvement after 6 months treatments. For example, one of the men who used to fall off the bed several times a year before treatment, hasn't fallen off again from the bed after 6 months treatment. Further, two of the men in this group had improved memories after the treatment. The other three men in this group have not shown remarkable improvements. Another group of 4 men aged 80-85 with Alzheimer's disease were supplied with placebo multivitamins, who showed no improvement in their behaviors.
[0114] Although the present invention has been described herein with respect to a number of specific illustrative embodiments, the foregoing description is intended to illustrate, rather than to limit the invention. Those skilled in the art will realize that many modifications of the illustrative embodiment could be made which would be operable. All such modifications, which are within the scope of the claims, are intended to be within the scope and spirit of the present invention.