WO2016126667A1

WO2016126667A1 - Palladium-based complex dietary supplement composition and method

Info

Publication number: WO2016126667A1
Application number: PCT/US2016/016106
Authority: WO
Inventors: Bobbi Jo MCAULIFFE
Original assignee: Mcauliffe Bobbi Jo
Priority date: 2015-02-02
Filing date: 2016-02-02
Publication date: 2016-08-11

Abstract

A dietary supplement for daily oral ingestion by adult human beings, said dietary supplement including a palladium-lipoic acid compound. In some embodiments, the dietary supplement also includes glucosamine sulfate. In some embodiments, the dietary supplement also includes sasparilla extract. In some embodiments, the dietary supplement also includes glycerin, potassium sorbate, and/or sodium benzoate. In many embodiments, the dietary supplement includes a water base, and the dietary supplement is ingested as a liquid medication or supplement.

Description

38264.10 1

TITLE OF INVENTION PALLADIUM-BASED COMPLEX DIETARY SUPPLEMENT COMPOSITION AND METHOD

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This Application claims the benefit of U.S. Provisional Patent Application No.

62/110,906, filed February 2, 2015, the entire content of which is incorporated herein by reference.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR

DEVELOPMENT

[0002] Not Applicable

BACKGROUND OF THE INVENTION

1. Field of Invention

[0003] The present invention relates to a daily-use dietary supplement for adults.

2. Description of the Related Art

[0004] Lipoic acid (also known as 6,8-dithio octanoic acid, thioctic acid, or alpha- lipoic acid, and hereinafter simply "lipoic acid") is a nutrient that the human body produces in discrete quantities. Lipoic acid can also be obtained from a number of sources, such as liver and some types of yeast. Used as a nutritional supplement, lipoic acid can significantly increase the human body's utilization of blood sugar in Type II diabetics; additionally, lipoic acid may increase the metabolic clearance rate of glucose by 50% in some diabetics. In some cases, lipoic acid has been used as a substitute for insulin in the treatment of Type II diabetes.

[0005] Under certain conditions palladium forms complexes with organic compounds to form a number of organo-metallic pharmaceutical compounds. U.S. Patent Number 5,463,093, issued in 1995 to Garnett, discloses a number of palladium complexes and pharmaceutical compositions including lipoic acid. That reference also discloses a process 38264.10 2 for preparing such complexes, as well as a method of treatment of tumors and a method of treatment of psoriasis comprising administering the described pharmaceutical compositions. U.S. Patent Number 5,679,697, issued in 1997, also to Garnett, includes similar disclosure.

[0006] Ramachandran et al. examined a dietary supplement, POLY-MVA, containing a palladium-lipoic acid complex for its efficacy as a radioprotector in mice exposed to whole- body γ-radiation. Oral administration of POLY-MVA enhanced endogenous spleen colony formation in animals exposed to a sublethal dose of 6 Gy γ-radiation. Alkaline comet assay revealed that the nuclear DNA comet parameters such as percent DNA in tail, tail length, tail moment, and olive tail moment, of the bone marrow cells and spleen cells, were found increased following whole-body γ-irradiation. The radiation-induced DNA damage in these cells was reduced when POLY-MVA was administered to animals exposed to a lethal dose of 8 Gy whole-body γ-radiation. The administration of POLY-MVA significantly reduced the γ- radiati on-induced mortality and also aided recovery from the radiation-induced loss of body weight in mice surviving after 8 Gy γ-radiation exposure. These results suggest the potential use of POLY-MVA as a radioprotector in cases of planned radiation exposures. Lakshmy Ramachandran, Chirakkal V. Krishnan, Cherupally Krishnan Krishnan Nair, Cancer Biotherapy & Radiopharmaceuticals, August 2010, 25(4): 395-399. doi: 10.1089/ cbr.2009.0744.

[0007] Menon et al. evaluated POLY MVA for its potential to enhance the repair of radiation-induced DNA damage. Treatment of human peripheral blood leukocytes with POLY MVA immediately after radiation exposure enhanced the repair of cellular DNA as revealed by comet assay. Post-irradiation administration of POLY MVA to mice resulted in faster cellular DNA repair, as revealed from the increased Cellular Repair Index (CRI) of blood leukocytes and bone marrow cells. Exposure of mice to 2 Gy whole-body gamma radiation resulted in the formation of strand breaks of cellular DNA of bone marrow cells, and the unrepaired strand breaks eventually lead to the formation of micronuclei in the reticulocytes. Administration of POLY MVA under post-irradiation conditions showed a decrease in the number of micronucleated reticulocytes. Thus, the studies under ex vivo and in vivo conditions revealed that the enhancement of DNA repair could be one of the mechanisms underlying radioprotection by POLY MVA. Aditya Menon, Cherupally 38264.10 3

Krishnan Krishnan Nair, International Journal of Low Radiation, November 2011, 8(1): 42- 54. doi:0.1504/ IJLR.2011.040648.

BRIEF SUMMARY OF THE INVENTION

[0008] The present invention includes, in some embodiments, a dietary supplement for daily oral ingestion by adult human beings, said dietary supplement including a palladium-lipoic acid compound. In some embodiments, the dietary supplement also includes glucosamine sulfate. In some embodiments, the dietary supplement also includes sasparilla extract. In some embodiments, the dietary supplement also includes glycerin, potassium sorbate, and/or sodium benzoate. In many embodiments, the dietary supplement includes a water base, and the dietary supplement is ingested as a liquid medication or supplement.

[0009] In some embodiments of the present general inventive concept, a dietary supplement composition comprises: lipoic acid or a derivative thereof; palladium, at least some of said palladium forming a complex with at least some of said lipoic acid; and a material selected from the group consisting of glucosamine sulfate and sapsarilla extract. In some embodiments, said dietary supplement composition includes glucosamine sulfate and sapsarilla extract. In some embodiments, said dietary supplement composition further includes coenzyme QIO. In some embodiments, said dietary supplement composition further includes Vitamin B12. In some embodiments, said dietary supplement composition further includes Vitamin D3. In some embodiments, said dietary supplement composition further includes glycerin, potassium sorbate, or sodium benzoate. In some embodiments, one dose of said dietary supplement composition comprises between 4 and 6 milliliters of liquid.

[0010] Some embodiments of the present general inventive concept comprise a method for supplementing the diet of an adult human being, said method including administering to the human being a supplement composition comprising lipoic acid or a derivative thereof, palladium, glucosamine sulfate, and sasparilla extract. In some embodiments, said supplement composition further includes coenzyme QIO. In some embodiments, said supplement composition further includes Vitamin B12. In some embodiments, said supplement composition further includes Vitamin D3. 38264.10 4

DETAILED DESCRIPTION OF THE INVENTION

[0011] The present invention includes, in some embodiments, a dietary supplement composition for daily oral ingestion by adult human beings, said dietary supplement compositionincluding a palladium-lipoic acid compound. In some embodiments, the dietary supplement composition also includes glucosamine sulfate. In some embodiments, the dietary supplement composition also includes sasparilla extract. In some embodiments, the dietary supplement composition also includes glycerin, potassium sorbate, and/or sodium benzoate. In many embodiments, the dietary supplement composition includes a water solvent or carrier, and the dietary supplement composition is ingested as a liquid medication or supplement.

[0012] Cancer cells are anaerobic— i.e., they require an absence of free oxygen to survive. On the other hand, normal cells are aerobic; that is, they need oxygen in order to live and grow. Lipoic acid is a strong anti-oxidant; it is a crucial facilitator of many enzymes and is essential for aerobic respiration. When lipoic acid is bound together with palladium, the metallo-organic complex becomes water-soluble and fat-soluble, allowing the complex to move throughout the body, even across the blood-brain barrier.

[0013] A healthy human cell in an oxygen-rich environment generates an appropriately strong electrical current in the cell that stimulates the mitochondria. This results in the high production of energy during cellular respiration, when the chemical bonds of energy-rich molecules are converted into energy usable for life processes. Amongst these important functions is apoptosis, which relates to the cell's own demise. Apoptosis is the process by which cells in a multi-cellular organism deliberately relinquish life as a means to benefit the entire organism. It includes a series of biochemical reactions that bring about the cellular death and safely discard the remains of the dead cell. This capacity to facilitate an cell death and replacement is a programmed cellular function that is essential for the healthy development, growth and continued life of a complex lifeform. However, the anaerobic respiration of a cancer cell does not have the capacity to generate more than a low cellular electrical current. This results in a low production of energy during respiration. Compared to aerobic respiration, anaerobic respiration only produces about 5% as much ATP. Without sufficient amounts of energy, cellular activities are greatly diminished. One of the activities 38264.10 5 that the cancer cell is no longer capable of carrying out is apoptosis. That is, the cell is no longer able to kill itself. Without programmed cell death, the replication of cancer cells is carried out without control— producing tumors.

[0014] Palladium and lipoic acid are combined to form a water-soluble and fat- soluble palladium-lipoic acid compound. The palladium-lipoic acid compound provides the basis of the dietary supplement composition. In some embodiments, the dietary supplement composition also includes glucosamine sulfate and sapsarilla extract. In some embodiments, the combination of palladium-lipoic acid compound, glucosamine sulfate, and sapsarilla extract amounts to approximately 120 milligrams.

[0015] Sarsaparilla is essentially a blood purifier that acts mainly in the colon. It controls the balance of colonic flora and binds toxins produced by resident yeasts and bacteria. Most of the bitter principles in the root are not absorbed appreciably into the blood and instead are activated only in alkaline solutions like the environment of the colon. This prevents them from interfering with the processes of digestion and absorption in the upper digestive tract. In the lower bowel, they react with the alkaline media and bind to a variety of toxins, including allergens. Many allergic reactions to colonic flora metabolites are manifested as inflammations, accounting for the popular history of sarsaparilla in the treatment of rheumatism, arthritis, inflammatory bowel conditions, and skin inflammations including psoriasis. Sarsaparilla, like yucca, binds to these toxins and causes them to be eliminated from the bowel. Sarsaparilla has also shown some antibiotic activity. Sarsaparilla root contains bitter compounds that increase the production of urine and promote sweating. These compounds also relieve inflammation and muscle spasms. Further, sarsaparilla is an herbal source of chromium, cobalt, iron and selenium. It has been used to treat rheumatism, gout, fevers, inflammatory skin conditions, prostatitis and impotence.

[0016] In some embodiments, a dietary supplement composition according to the present general inventive concept includes coenzyme Q 10 (hereinafter "CoQl O"). CoQ lO is an oil-soluble, vitamin-like substance present in most eukaryotic cells and present especially in the mitochondria. CoQlO is a component of the electron transport chain and participates in aerobic cellular respiration. In some embodiments, the dietary supplement composition includes approximately 400 micrograms of CoQlO. 38264.10 6

[0017] In some embodiments, a dietary supplement composition according to the present general inventive concept includes Vitamin B12. Vitamin B12, also called cobalamin, is a water-soluble vitamin with a key role in the normal functioning of the brain and nervous system, and for the formation of blood. It is normally involved in the metabolism of every cell of the human body, affecting DNA synthesis and regulation, also fatty acid synthesis, and energy production. In some embodiments, the dietary supplement composition includes approximately 3,000 International Units of Vitamin B12.

[0018] In some embodiments, a dietary supplement composition according to the present general inventive concept includes Vitamin D3. Vitamin D3, or cholecalciferol, is used in the regulation of metabolism. In some embodiments, the dietary supplement composition includes approximately 5,000 International Units of Vitamin D3.

[0019] The dietary supplement compositions of the present general inventive concept may be provided in liquid or powder form, with powders suitable for mixing with water or other liquids being preferred. The dietary supplement compositions in powder or granular form may be provided in accordance with customary processing techniques, for example as spray dried powders, or the like.

[0020] Thus, in some embodiments of the present general inventive concept, a dietary supplement composition comprises: lipoic acid or a derivative thereof; palladium, at least some of said palladium forming a complex with at least some of said lipoic acid; and a material selected from the group consisting of glucosamine sulfate and sapsarilla extract. In some embodiments, said dietary supplement composition includes glucosamine sulfate and sapsarilla extract. In some embodiments, said dietary supplement composition further includes CoQIO, Vitamin B12, and/or Vitamin D3. In some embodiments, said dietary supplement composition further includes glycerin, potassium sorbate, or sodium benzoate. In some embodiments, one dose of said dietary supplement composition comprises between 4 and 6 milliliters of liquid, or approximately 1 teaspoon.

[0021] In some embodiments of the present general inventive concept, a method for supplementing the diet of an adult human being comprises administering to the human being a supplement composition comprising lipoic acid or a derivative thereof, palladium, glucosamine sulfate, and sasparilla extract. In some embodiments, said supplement 38264.10 7 composition further includes coenzyme Q10. In some embodiments, said supplement composition further includes Vitamin B12. In some embodiments, said supplement composition further includes Vitamin D3.

[0022] While the present invention has been illustrated by description of several embodiments and while the illustrative embodiments have been described in considerable detail, it is not the intention of the applicant to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art. The invention in its broader aspects is therefore not limited to the specific details, representative apparatus and methods, and illustrative examples shown and described. Accordingly, departures may be made from such details without departing from the spirit or scope of applicant's general inventive concept.

Claims

38264.10 8 CLAIMS What is claimed is:

1. A dietary supplement composition, comprising:

lipoic acid or a derivative thereof;

palladium, at least some of said palladium forming a complex with at least some of said lipoic acid; and

a material selected from the group consisting of glucosamine sulfate and sapsarilla extract.

2. The dietary supplement composition of claim 1 wherein said dietary supplement composition further includes coenzyme Q10.

3. The dietary supplement composition of claim 1 wherein said dietary supplement composition includes glucosamine sulfate and sapsarilla extract.

4. The dietary supplement composition of claim 1 wherein said dietary supplement composition further includes Vitamin B12.

5. The dietary supplement composition of claim 1 wherein said dietary supplement composition further includes Vitamin D3.

6. The dietary supplement composition of claim 1 wherein said dietary supplement composition further includes glycerin, potassium sorbate, or sodium benzoate.

7. The dietary supplement composition of claim 1 wherein one dose of said dietary supplement composition comprises between 4 and 6 milliliters of liquid.

8. A method for supplementing the diet of an adult human being, comprising administering to the human being a supplement composition comprising lipoic acid or a derivative thereof, palladium, glucosamine sulfate, and sasparilla extract.

9. The method of claim 8 wherein said supplement composition further includes coenzyme Q10.

38264.10 9

10. The method of claim 8 wherein said supplement composition further includes Vitamin B 12.

11. The method of claim 8 wherein said supplement composition further includes Vitamin D3.