AU2021106872A4 - Compositions and methods for maintaining/improving liver and kidney health - Google Patents

Abstract

The present invention relates to compositions comprising a combination of one or more B vitamins, phosphatidylserine and lipoic acid and the use of such compositions in maintaining or improving liver and/or kidney function and in treating impaired liver and/or kidney function. The compositions include, but are not limited to, dietary supplements e.g., nutritional supplements, and may also slow the age-related decline in liver and/or kidney function.

Description

Compositions and method for maintaining/improving liver and kidney health

Field of the Invention

[0001] The present invention relates to compositions comprising a combination of one or more B vitamins and a phospholipid and/or a lipoic acid and/or methods of using the same combination for maintaining/improving health, including maintaining/improving kidney and liver function. The compositions include, but are not limited to, dietary supplements e.g., nutritional supplements, and may also slow the age-related decline in liver and/or kidney function.

Background of the Invention

[0002] Any discussion of the prior art throughout the specification should in no way be considered as an admission that such prior art is widely known or forms part of common general knowledge in the field.

[0003] A decline in the function of various organ systems is often considered a natural part of ageing or a consequence of environmental, lifestyle or genetic factors. Indeed, it is common for adults that are otherwise healthy to experience episodes of ill-health that may be primarily attributed to one organ system.

[0004] However, given the increase in life expectancy of people, coupled with increasing demands on health and assisted living infrastructure by the elderly, there is a desire to maintain a high degree health and mobility of the ageing population.

[0005] Therapeutic and preventative treatments for maintaining liver and kidney function are particularly important, since the occurrence of diseases and disorders associated with these organs become more prevalent with age. Accordingly, the prevalence and incidence of liver and kidney disease is expected to increase dramatically over the coming decades as the world's population continues to age.

[0006] Thus, not only is there a current large economic and social burden from the population of humans with liver and/or kidney disease, these burdens are also expected to increase dramatically.

[0007] The aetiologies of disease and disorders that affect liver and/or kidney function are complex, multifaceted, and not fully understood. However, there are links between the levels of various markers and enzymes in the blood that can be indicative of fluctuations in liver and/or kidney function.

[0008] Improving liver and/or kidney function or slowing the decline of liver and/or kidney function in healthy adults and elderly people, or ageing individuals is desirable for increasing quality of life and perhaps to delay the onset of kidney and liver diseases in later life. Use of nutritional supplements or compositions that may be taken as dietary supplements would also represent attractive cost-effective alternatives.

[0009] There remains a need for safe, cheap and effective therapies, e.g., effective nutritional supplements or dietary supplementation to maintain or improve liver and/or kidney function or slow the decline of liver and/or kidney function in healthy and/or elderly individuals.

[0010] It is an objective of the present invention to overcome or ameliorate at least one of the disadvantages of the prior art treatments, or to provide a useful alternative.

Summary of the Invention

[0011] In a first aspect, the present invention provides a method for maintaining/improving liver function and/or slowing age-related decline in liver function of an adult subject comprising administering a composition comprising:

(i) one or more B vitamins, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof; and

(ii) phosphatidylserine, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof; and

(iii) lipoic acid, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof,

in amounts and for a time sufficient to maintain/improve liver function and/or slow the age related decline in liver function of said adult subject.

[0012] In a second aspect, the present invention provides a use of an effective amount of a combination of:

(i) one or more B vitamins, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof; and

(ii) phosphatidylserine, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof; and

(iii) lipoic acid, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof,

in the manufacture of a medicament, dietary/nutritional supplement, or nutraceutical for maintaining/improving liver function and/or slowing age-related decline in liver function of an adult subject.

[0013] In a third aspect, the present invention provides a method for maintaining/improving kidney function and/or slowing age-related decline in kidney function of an adult subject comprising administering a composition comprising:

(i) one or more B vitamins, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof; and

(ii) phosphatidylserine, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof; and

(iii) lipoic acid, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof,

in amounts and for a time sufficient to maintain/improve kidney function and/or slow the age related decline in kidney function of said adult subject.

[0014] In a fourth aspect, the present invention provides a use of an effective amount of a combination of:

(i) one or more B vitamins, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof; and

(ii) phosphatidylserine, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof; and

(iii) lipoic acid, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof,

in the manufacture of a medicament, dietary/nutritional supplement, or nutraceutical for maintaining/improving kidney function and/or slowing age-related decline in kidney function of an adult subject.

[0015] A number of different adult subjects are contemplated for any aspect and/or example described herein. The adult subjects may be healthy adults, or adults that have a history or liver and/or kidney disease, or adults that have a predisposition (either through genetics, environment or lifestyle, such as excessive alcohol, drug or herbal supplement consumption) for liver and/or kidney disease, or adults that are suspected of having liver and/or kidney disease, or adults that have temporary issues with liver and/or kidney function. For example, subject(s) may be tested for biochemical, genetic, or other risk factors and/or markers that indicate that the subject(s) has a pre-disposition and/or at risk of developing to liver or kidney disease or other similar ailments.

[0016] The healthy adult may have no physical or clinical signs or manifestations of liver and/or kidney disease. The healthy adult may have fluctuations in liver and/or kidney function, but these fluctuations may fall within a normal or acceptable range, as determined by a clinician.

[0017] The age of the adult subjects may vary. Adult subjects may include biological adults, e.g., subjects that have completed puberty and may include any subjects over the age of about 10 e.g., about 10 to 95 years. Typically, an adult subject is considered to be a subject over the age of 18, e.g., 18 to 95 years. For example, adult subjects may be between the ages of about 18 to 90 years, or about 20 to 90 years, or about 25 to 90 years, or about to 90 years, or about 35 to 90 years, or about 40 to 90 years, or about 45 to 90 years, or about 50 to 90 years, or about 55 to 90 years, or about 60 to 90 years, or about 65 to 90 years, or about 70 to 90 years, or about 75 to 90 years, or about 80 to 90 years, or about 85 to 90 years, or about 18 to 85 years, or about 18 to 80 years, or about 18 to 75 years, or about 18 to 70 years, or about 18 to 65 years, or about 18 to 60 years, or about 18 to 55 years, or about 18 to 50 years, or about 18 to 45 years, or about 18 to 40 years, or about 18 to 30 years, about 18 to 25 years, or about 25 to 30 years, or about 30 to 35 years, or about to 40 years or about 40 to 45 years, or about 45 to 50 years, or about 50 to 55 years, or about 55 to 60 years, or about 60 to 65 years, or about 65 to 70 years, or about 70 to 75 years, or about 75 to 80 years, or about 80 to 85 years, or about 85 to 90 years, or about 90 to 95 years, or about 30 to 40 years, or about 40 to 50 years, or about 50 to 60 years, or about 60 to 70 years, or about 70 to 80 years, or about 80 to 90 years. In another example, the adult subjects may be elderly subjects between the ages of about 50 to 65 years, or about 60 to 75 years, or about 70 to 85 years, or about 80 to 95 years.

[0018] The adult subject may be an aging subject. Ageing subjects includes any one or more of the described adult subjects that increase in age. Preferably, ageing subjects includes those adult subjects that are above the age of about 30 or more. Ageing subjects also includes elderly subjects. Preferably, the subjects are healthy adult subjects.

[0019] The adult subject may have a liver with impaired function. It would be understood that the functions of the liver include, but are not limited to, the production of proteins, clotting factors, enzymes and hormones, the storage vitamins and minerals, the digestion of food, and the metabolism and expulsion of toxic substances from the body. In embodiments of the invention, the compositions treat impaired liver function in healthy adults, or improve liver function in healthy adults.

[0020] Symptoms of impaired liver function may include yellowish skin and eyes, abdominal pain and swelling, swelling in the legs and ankles, irritated skin, dark urine or stools, fatigue, weakness, loss of appetite, nausea, tendency to bruise, unexplained weight gain or loss, and diarrhea. In embodiments of the invention, the subject demonstrates one of more of these symptoms sporadically, acutely and/or chronically to varying degrees. In other embodiments of the invention, the subject has impaired liver function but does not demonstrate any of these symptoms.

[0021] Impaired liver function may be demonstrated by liver function test results. Liver function may be measured by a range of means. These means include, but are not limited to, quantitative assessments of blood levels of total protein, albumin, bilirubin, alkaline phosphatase, aspartate aminotransferase (AST), alkaline phosphatase (ALP), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), lactate dehydrogenase (LD), alpha-feto protein and autoimmune antibodies such as ANA, SMA, anti-LKM-1. Liver function may also be assessed via a prothrombin time (PT) test, which measures clotting function. Diseases and disorders associated with impaired liver function may also be detected by imaging or biopsy.

[0022] In general, normal results for some of the aforementioned liver function tests would fall within the following ranges: 64 - 83 g/L total protein; 32-48 g/L albumin; 2-20 umol/L bilirubin; 30-150 U/L ALP; 10-35 U/L GGT; 10-50 U/L AST; and 0-30 U/L ALT.

[0023] The adult subject of any aspect and/or example described herein may also include patients that have one or more diseases or disorders associated with impaired liver function, or be predisposed to one or more diseases or disorders associated with impaired liver function selected from the group consisting of Hepatitis (A, B, C or D), cirrhosis, Alagille syndrome, alcohol-related liver disease, Alpha-1 antitrypsin deficiency, autoimmune hepatitis, benign liver tumours, biliary atresia, galactosemia, Gilbert syndrome, hemochromatosis, hepatic encephalopathy, intrahepatic cholestasis of pregnancy (ICP), lysosomal acid lipase deficiency (LAL-D), liver cysts, liver cancer, bile duct cancer, non alcoholic fatty liver disease, primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), Reye syndrome, Type I glycogen storage disease, bile duct obstructions, and Wilson disease.

[0024] The adult subject may have at least one kidney that is impaired. It would be understood that the functions of the kidney include, but are not limited to, the filtration of blood to remove waste products that form during metabolism and cellular activity, regulation of pH levels and important chemicals such as salts, minerals, proteins and glucose in the body and blood, and recirculating necessary chemicals back to the blood. In embodiments of the invention, the compositions treat impaired kidney function in healthy adults, or improves kidney function in healthy adults.

[0025] Symptoms of impaired kidney function may include swelling or puffiness around the body including eyes, face, wrist, stomach, thighs or ankles, foamy, bloody or dark urine, decreased amount of urine or problems urinating, pain in the kidney area, tiredness, loss of appetite, sleeping problems, shortness of breath, muscle cramps, inability to concentrate, headaches and high blood pressure. In embodiments of the invention, the subject demonstrates one of more of these symptoms sporadically, acutely and/or chronically to varying degrees. In other embodiments of the invention, the subject has impaired kidney function but does not demonstrate any of these symptoms.

[0026] Impaired kidney function may be demonstrated by impaired kidney function test results. Kidney function may be measured by a range of means. These means include, but are not limited to, quantitative assessments of blood and/or urine levels of sodium, potassium, chloride, bicarbonate, phosphorus, calcium, albumin, urea/blood urea nitrogen (BUN), creatinine and glucose. Kidney function may also be assessed via an estimated Glomerular Filtration Rate (eGFR) test, which measures the amount of blood filtered by the kidneys per minute, and an Anion gap test, which evaluates the difference between measured and unmeasured electrolytes/ions in the fluid portion of the blood. Diseases and disorders associated with impaired kidney function may also be detected by imaging or biopsy.

[0027] In general, normal results for some of the aforementioned kidney function tests would fall within the following ranges: 135-145 mmol/L Sodium; 3.5-5.2 mmol/L Potassium; 3.2-7.7 mmol/L urea; 45-90 umol/L creatinine; eGFR of 80-120 mL/min/1.73m 2

[0028] The adult subject of any aspect and/or example described herein may also include patients that have one or more diseases or disorders associated with impaired kidney function, or be predisposed to one or more diseases or disorders associated with impaired kidney function selected from the group consisting of high blood pressure, diabetes, cardiovascular disease, obesity, elevated cholesterol, kidney disease, acute kidney injury, glomerulonephritis, polycystic kidney disease, reflux nephropathy, kidney cancer, bladder cancer and diabetic nephropathy.

[0029] Liver and kidney function are measurable using the above-mentioned tests over any time-frame e.g., hours, days, weeks, months or years. Liver and/or kidney function which has not changed or has increased over one or more described time-frames, is considered to be maintained or improved in the adult subject, e.g., in any subject described herein. Liver and/or kidney function may also decline with increasing age in an adult subject. In this example, liver and/or kidney function is measured over longer time-frames, e.g., months or years in ageing subjects as described herein. The liver and/or kidney function is measured at two or more time points in an ageing subject. For example, the decline in liver and/or kidney function in an ageing subject may be measured between several months or several years to establish a rate of decline. The rate of decline may be compared to a standard known in the art taking into consideration the age of the subject. The rate of decline may also be compared to liver and/or kidney function that is then measured again in the same subject, after the subject has aged for a further period of months or years. Age-related decline is considered slowed if the rate of decline that is less compared to the standard or compared to a second measurement is less.

[0030] It will be apparent to the skilled artisan that since liver and/or kidney function function may be measured, a time sufficient to maintain/improve liver and/or kidney function and/or slow the age-related decline in liver and/or kidney function the adult subject may be determined as required. For example the time may be 1 month, or 2 months, or 3 months, or 4 months, or 5 months, or 6 months, or 7 months, or 8 months, or 9 months or 10 months, or 11 months, or 12 months. In another example, the time may be 1 to 2 years, or 2 to 4 years, or 4 to 6 years, or 6 to 8 years or 8 to 10 years, or greater than 10 year. It will also be apparent that the time of administration may be continued for the life of the adult subject.

[0031] Liver and/or kidney function may be measured using any test or assay known in the art for such purposes The levels and/or activities of a parameter described herein may be measured at a time-frame as described according to any aspect, embodiment and/or example herein. It will be apparent to a person skilled in the art whether or not a there is a significant change in the level and/or activity of any one or more parameters described according to any aspect, embodiment and/or example herein.

[0032] In certain examples, the present disclosure provides a method of treating impaired liver function in a subject the method comprising administering to the subject a therapeutically effective amount of a composition comprising: one or more B vitamins, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof; phosphatidylserine, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof; and lipoic acid, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof.

[0033] In certain examples, the present disclosure provides a method of treating impaired kidney function in a subject the method comprising administering to the subject a therapeutically effective amount of a composition comprising: one or more B vitamins, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof; phosphatidylserine, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof; and lipoic acid, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof.

[0034] The B vitamins of any aspect and/or example described herein may comprise any one or more of B vitamins includingB 1, B 2, B 3, B5 , B6, B 7, B, B 12 . In one example, one or more B vitamins are combined with phosphatidylserine. In another example, one or more B vitamins are combined with lipoic acid. In another example, one or more B vitamins are combined with phosphatidylserine and lipoic acid. Preferably, the B vitamins comprise any one or more of vitamins B6 ,B9 and/or B 12 . In one example, vitamin B 6 is included in any aspect of the invention. In another example, vitamin B 9 is included in any aspect of the invention. In another example vitamin B 12 is included in any aspect of the invention. In another example, vitamins B 6, and Be are included in any aspect of the invention. In another example, vitamins B 6, Be and B 12 are included in any aspect of the invention.

[0035] Any alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, of the B-Vitamins that are known to the skilled artisan are also contemplated. Alternative forms include vitamers. As used herein, the alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, includes known biologically active forms and/or have measurable activity as described in any known assay used in the art to measure the function of B vitamins.

[0036] For example, any one or more vitamin B6 may include, but is not limited to pyridoxine, pyridoxal, pyridoxamine, pyridoxine 5'-phosphate, pyridoxal 5'-phosphate, and pyridoxamine 5'-phosphate, or other alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof.

[0037] For example, any one or more of vitamin B 9 , may include, but is not limited to folate, folic acid (folate, vitamin M, vitamin B9, vitamin Bc (or folacin), pteroylglutamic acid), or dihydrofolate, tetrahydrofolate, 5-methyltetrahydrofolate (L-methylfolate) or other alternative form(s), derivative(s), or salt(s) thereof (such as the calcium salt of L-5 methyltetrahydrofolate) or other alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof.

[0038] For example, any one or more form of vitamin 1 2B (C 3 8H8 CoN 14 0 14 P) may include, but is not limited to cyanocobalamin, methylcobalamin, hydroxocobalamin, adnenosylcobalamin, or other alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof.

[0039] Any one or more of the B vitamins, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof used in the preparation of any aspect and/or example of the invention may be anhydrous, or non-anhydrous.

[0040] The B vitamins, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof described herein may be obtained from commercially available sources and/or prepared or derived e.g., from foodstuffs according to methods known in the art. For example, B vitamins, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof may be derived from unprocessed foods such as, meat, turkey and tuna, liver and meat products, kombucha, whole grains, potatoes, bananas, lentils, chili peppers, tempeh, beans, nutritional yeast, brewer's yeast, and molasses. The B vitamins, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof may also be chemically synthesized. It will also be apparent to the skilled artisan that any extract or foodstuff rich in B vitamins, or alternative form(s), derivative(s), or salt(s) thereof, may also be used.

[0041] The phosphatidylserine (Ptd-L-Ser or PS) of any aspect and/or example described herein may be used in pure or purified form from commercially available sources and/or chemically synthesized and/or prepared from PS rich sources, e.g., bovine brain and/or soy bean or combinations thereof, or it may also be provided in the form of an extract or foodstuff rich PS. Any alternative form(s), derivative(s), or salt(s) thereof, of PS that are known to the skilled artisan are also contemplated. As used herein, the alternative form(s), derivative(s), salt(s) thereof, or combinations thereof, includes known biologically active forms and/or have measurable activity as described in any known assay used in the art to measure the function and/or activity of PS. Without limitation, an example of an alternative form of PS includes conjugated phoshpatidylserine-omega-3 compound.

[0042] Due to the occurrence of Bovine spongiform encephalopathy (BSE) commonly known as mad-cow disease, alternative sources of PS are preferable, e.g., soy derived PS. However, it will also be apparent to the skilled artisan that bovine derived PS may also be used, should such bovine derived PS be found risk-free from BSE pathogen and/or safe for human consumption.

[0043] The lipoic acid (5-(1,2-dithiolan-3-yl)valeric acid), includes a-lipoic acid (ALA), thioctic acid or 6,8-Dithioctanoic acid. The lipoic acid of any aspect and/or example described herein may include one or a mixture of both enantiomers (R)-(+)-lipoic acid (RLA) or (S)-(-)-lipoic acid (SLA) at various concentrations including a racemic mixture (R/S)-lipoic acid (R/S-LA). Any one or more of these forms of lipoic acid may be used in pure or purified form from commercially available sources and/or chemically synthesized and/or prepared from ALA rich sources e.g., kidney, heart, liver, spinach, broccoli, and yeast extract or combinations thereof, or lipoic acid may also be provided in the form of an extract or foodstuff rich in lipoic acid. Commercially available forms include, but are not limited to, dihydrolipoic acid and salts thereof. Any alternative form(s), derivative(s), or salt(s) thereof, of lipoic acid that are known to the skilled artisan are also contemplated. As used herein, the alternative form(s), derivative(s), salt(s) thereof, or combinations thereof, includes known biologically active forms and/or have measurable activity as described in any known assay used in the art to measure the function and/or activity of lipoic acid. Examples of biologically active forms of lipoic acid include lipoate.

[0044] Use of the (R)-(+)-lipoic acid (RLA) enantiomer and/or salts thereof in any aspect and/or example described herein is preferred.

[0045] The composition of the invention or the combination of B-vitamins and PS and/or lipoic acid according to any aspect and/or example described herein may be administered by any suitable route. The B-vitamins according to any aspect and/or example described herein may be administered separately, simultaneously or sequentially, in any order with the PS and/or lipoic acid according to any aspect and/or example described herein. The preferred route of administration is oral. The composition of the invention or the combination of B vitamins and PS and/or lipoic acid according to any aspect and/or example described herein may be administered as a supplement in daily meals or beverages. Administration may also include in a pharmaceutical unit dosage form such as pills, tablets, caplets, tabsules or capsules, for better control of dosing and subject compliance. The composition of the invention or the combination of B-vitamins and PS and/or lipoic acid or the unit dosage form according to any aspect and/or example described herein may be administered once, or twice or three times or 4 times a day. Preferably, administration is 1 or 2 times daily. Preferably, administration is twice daily.

[0046] For example, an effective amount of the combination or an administration dosage according to the invention may include about 1 pg to about 200 mg of each B vitamin, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In one example, the effective amount or the administration dosage includes about 100 pg to about 5 mg of vitamin B, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In another example, the effective amount or the administration dosage includes about 200 pg to about mg of vitamin B, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In another example, the effective amount or the administration dosage includes about 400 pg to about 5 mg of vitamin B 9 , or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In another example, the effective amount or the administration dosage includes about 800 pg to about 5 mg of vitaminB 9 , or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In another example, the effective amount or the administration dosage includes about 1.6 mg to about 5 mg of vitamin B 9 , or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In another example, the effective amount or the administration dosage includes about 3.2 mg to about 5 mg of vitamin B 9 , or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. For example, the effective amount or the administration dosage includes about 100 pg, or about 150 pg, or about 200 pg, orabout250 pg, orabout300 pg, orabout350 pg, orabout400 pg, orabout450 pg, or about500 pg, orabout550 pg, orabout600 pg, orabout650 pg, orabout700 pg, orabout 750 pg,orabout800 pg, orabout850 pg, orabout900 pg, orabout950 pg,orabout1.0 mg, or about 1.1 mg, or about 1.3 mg, or about 1.4 mg, or about 1.5 mg, or about 1.6 mg, or about 1.7 mg, or about 1.8 mg, or about 1.9 mg, or about 2.0 mg, or about 2.2 mg, or about 2.4 mg, or about 2.8 mg, or about 3.0 mg, or about 3.2 mg, or about 3.4 mg, or about 3.8 mg, or about 4.0 mg, or about 4.2 mg, or about 4.4 mg, or about 4.8 mg, or about 5.0 mg of vitamin B 9 , or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. Preferably, the effective amount or the administration dosage includes about 200 pg of vitamin B, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. Administration may be once, or twice or three times or 4 times a day. Preferably, administration is twice daily. The effective amount as described herein may be in the form of a single unit dosage. The effective amount, or the single unit dosage may be administered once, twice or three times or 4 times a day. Preferably, the effective amount, or the single unit dosage is administered twice daily.

[0047] In another example, an effective amount of the combination or an administration dosage according to the invention includes about 1.2 pg to about 1.5 mg of vitamin B 1 2 , or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In another example, the effective amount or the administration dosage includes about 10 pg to about 1.5 mg of vitamin B 1 2 , or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In another example, the effective amount or the administration dosage includes about 25 pg to about 1.5 mg of vitamin B 12 , or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In another example, the effective amount or the administration dosage includes about 50 pg to about 1.5 mg of vitamin B 12 , or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In another example, the effective amount or the administration dosage includes about 100 pg to about 1.5 mg of vitamin B 12 , or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In another example, the effective amount or the administration dosage includes about 200 pg to about 1.5 mg of vitamin B 1 2 , or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In another example, the effective amount or the administration dosage includes about 400 pg to about 1.5 mg of vitamin B 12 ,

or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In another example, the effective amount or the administration dosage includes about 800 pg to about 1.5 mg of vitamin B 12 , or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. For example, the effective amount or the administration dosage includes about 1.2 pg, or about 1.5 pg, or about 2.0 pg, or about 2.5 pg, or about 3.0 pg, or about 3.5 pg, or about 4.0 pg, or about 4.5 pg, or about 5.0 pg, or about 5.5 pg, or about 6.0 pg, or about 6.5 pg, or about 7.0 pg, or about 7.5 pg, or about 8.0 pg, or about 8.5 pg , or about 9.0 pg , or about 9.5 pg, or about 0.1 mg, or about 0.2 mg, or about 0.3 mg, or about 0.4 mg, or about 0.5 mg, or about 0.6 mg, or about 0.7 mg, or about 0.8 mg, or about 0.9 mg, or about 1.0 mg, or about 1.1 mg, or about 1.2 mg, or about 1.3 mg, or about 1.4 mg, or about 1.5 mg of vitamin B 12, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. Preferably, the effective amount or the administration dosage includes about 250 pg of vitamin B12 , or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. Administration may be once, or twice or three times or 4 times a day. Preferably, administration is twice daily. The effective amount as described herein may be in the form of a single unit dosage. The effective amount, or the single unit dosage may be administered once, twice or three times or 4 times a day. Preferably, the effective amount, or the single unit dosage is administered twice daily.

[0048] In another example, an effective amount of the combination or an administration dosage according to the invention includes about 0.75 mg to about 200 mg of vitamin B6 , or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In another example, the effective amount or the administration dosage includes about 1.5 mg to about 200 mg of vitamin B 6, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In another example, the effective amount or the administration dosage includes about 3 mg to about 200 mg of vitamin B6 , or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In another example, the effective amount or the administration dosage includes about 6 mg to about 200 mg of vitamin B6 , Or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In another example, the effective amount or the administration dosage includes about 12 mg to about 200 mg of vitamin B6 , or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In another example, the effective amount or the administration dosage includes about 25 mg to about 200 mg of vitamin B6 , or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In another example, the effective amount or the administration dosage includes about 50 mg to about 200 mg of vitamin B6 , or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In another example, the effective amount or the administration dosage includes about 100 mg to about 200 mg of vitamin B 6, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. For example, the effective amount or the administration dosage includes about 0.75 mg, or about 1 mg, or about 5 mg, or about 10 mg, or about 11 mg, or about 12 mg, or about 13 mg, or about 14 mg, or about 15 mg, or about 16 mg, or about 17 mg, or about 18 mg, or about 19 mg, or about 20 mg, or about 25 mg, or about 30 mg, or about 35 mg, or about 40 mg, or about 45 mg, or about 50 mg, or about 55 mg, or about 60 mg, or about 65 mg, or about 70 mg, or about 75 mg, or about 80 mg, or about 85 mg, or about 90 mg, or about 95 mg, or about 100 mg, or about 120 mg, or about 140 mg, or about 160 mg, or about 180 mg, or about 200 mg of vitamin B6 , or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. Preferably, the effective amount or the administration dosage includes about 12.5 mg of vitamin B6 , or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. Administration may be once, or twice or three times or 4 times a day. Preferably, administration is twice daily. The effective amount as described herein may be in the form of a single unit dosage. The effective amount, or the single unit dosage may be administered once, twice or three times or 4 times a day. Preferably, the effective amount, or the single unit dosage is administered twice daily.

[0049] For example, an effective amount of the combination or an administration dosage according to the invention may include about 1 mg to about 1000 mg of phosphatidylserine, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In another example, the effective amount or the administration dosage includes about 5 mg to about 1000 mg of phosphatidylserine, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In another example, the effective amount or the administration dosage includes about 10 mg to about 1000 mg of phosphatidylserine, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In another example, the effective amount or the administration dosage includes about 20 mg to about 1000 mg of phosphatidylserine, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In another example, the effective amount or the administration dosage includes about 50 mg to about 1000 mg of phosphatidylserine, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In another example, the effective amount or the administration dosage includes about 100 mg to about 1000 mg of phosphatidylserine, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In another example, the effective amount or the administration dosage includes about 200 mg to about 1000 mg of phosphatidylserine, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In another example, the effective amount or the administration dosage includes about 400 mg to about 1000 mg of phosphatidylserine, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In another example, the effective amount or the administration dosage includes about 800 mg to about 1000 mg of phosphatidylserine, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. For example, the effective amount or the administration dosage includes about 1 mg, or about 2 mg, or about 3 mg, or about 4 mg, or about 5 mg, or about 6 mg, or about 7 mg, or about 8 mg, or about 9 mg, or about 10 mg, or about 11 mg, or about 12 mg, or about 13 mg, or about 14 mg, or about 15 mg, or about 16 mg, or about 17 mg, or about 18 mg, or about 19 mg, or about 20 mg, or about 21 mg, or about 22 mg, or about 23 mg, or about 24 mg, or about 25 mg, or about 26 mg, or about 27 mg, or about 28 mg, or about 29 mg, or about 30 mg, or about 35 mg, or about 40 mg, or about 50 mg, or about 60 mg, or about 70 mg, or about 80 mg, or about 90 mg, or about 100 mg, or about 150 mg, or about 200 mg, or about 250 mg, or about 300 mg, or about 350 mg, or about 400 mg, or about 450 mg, or about 500 mg, or about 550 mg, or about 600 mg, or about 650 mg, or about 700 mg, or about 750 mg, or about 800 mg, or about 850 mg, or about 900 mg, or about 950 mg, or about 1000 mg of phosphatidylserine, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. Preferably, the effective amount or the administration dosage includes about 25 mg of phosphatidylserine, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. Preferably, the effective amount or the administration dosage includes about 50 mg of phosphatidylserine, such as soy derived phosphatidylserine, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. Administration may be once, or twice or three times or 4 times a day. Preferably, administration is twice daily. The effective amount as described herein may be in the form of a single unit dosage. The effective amount, or the single unit dosage may be administered once, twice or three times or 4 times a day. Preferably, the effective amount, or the single unit dosage is administered twice daily.

[0050] For example, an effective amount of the combination or an administration dosage according to the invention may include about 50 mg to about 1200 mg of lipoic acid, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In another example, the effective amount or the administration dosage includes about 100 mg to about 1200 mg of lipoic acid or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In another example, the effective amount or the administration dosage includes about 150 mg to about 1200 mg of lipoic acid or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In another example, the effective amount or the administration dosage includes about 200 mg to about 1200 mg of lipoic acid or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In another example, the effective amount or the administration dosage includes about 400 mg to about 1200 mg of lipoic acid or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In another example, the effective amount or the administration dosage includes about 600 mg to about 1200 mg of lipoic acid or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In another example, the effective amount or the administration dosage includes about 800 mg to about 1200 mg of lipoic acid or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In another example, the effective amount or the administration dosage includes about 1000 mg to about 1200 mg of lipoic acid or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. For example, the effective amount or the administration dosage includes about 50 mg, or about 60 mg, or about 70 mg, or about 80 mg, or about 90 mg, or about 100 mg, or about 125 mg, or about 150 mg, or about 175 mg, or about 200 mg, or about 225 mg, or about 250 mg, or about 275 mg, or about 300 mg, or about 325 mg, or about 350 mg, or about 375 mg about 400 mg, or about 425 mg, or about 450 mg, or about 475 mg, or about 500 mg, or about 525 mg, or about 550 mg, or about 575 mg, or about 600 mg, or about 625 mg or about 650 mg, or about 675 mg, or about 700 mg, or about 725 mg, or about 750 mg, or about 775 mg, about 800 mg, or about 825 mg, or about 850 mg, or about 875 mg, or about 900 mg, or about 925 mg, or about 950 mg, or about 975 mg, or about 1000 mg of lipoic, or about 1100 mg, or about 1200 mg alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. Preferably, the effective amount or the administration dosage includes about 150 mg of lipoic acid, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. Administration may be once, or twice or three times or 4 times a day. Preferably, administration is twice daily. The effective amount as described herein may be in the form of a single unit dosage. The effective amount, or the single unit dosage may be administered once, twice or three times or 4 times a day. Preferably, the effective amount, or the single unit dosage is administered twice daily.

[0051] In another example, an effective amount of the combination or an administration dosage according to the invention may include the ratio of about 1:1.9:11.5 respectively of B vitamins alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof to phosphatidylserine, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof to lipoic acid, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In this example, theB-vitamins are in a ratio of about 1: 1 to 2.0: 20 to 65 respectively of vitamin B9 to vitamin B12 to vitamin B6. For example, the B-vitamins are in a ratio of about 1: 1.25: 62.5 respectively of vitamin B9 to vitamin B12 to vitamin B6.

[0052] In another example, an effective amount of the combination or an administration dosage according to the invention may include the ratio of about 1:1.0 to 2.0 :10 to 20 respectively of B-vitamins alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof to phosphatidylserine, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof to lipoic acid, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof described in any aspect and/or example of the invention. In this example, the B-vitamins are in a ratio of about 1: 1 to 2.0: 20 to 65 respectively of vitamin B9 to vitamin B12 to vitamin B6. For example, the B-vitamins are in a ratio of about 1: 1.25: 62.5 respectively of vitamin B9 to vitamin B12 to vitamin B6.

[0053] The composition of the invention or the combination of B-vitamins and PS and/or lipoic acid, or the unit dose according to any aspect and/or example described herein may be administered by a variety of routes including oral, rectal, transdermal, subcutaneous, intravenous, intramuscular, intrathecal, intraperitoneal, intranasal and buccal. Depending on the intended route of delivery, the compounds are preferably formulated as either oral, injectable or topical compositions. For example, oral formulation may be a conventional tablet or capsule form. In another example, the composition of the invention or the combination of B-vitamins and PS and/or lipoic acid according to any aspect and/or example described herein may be formulated e.g., as a pharmaceutical, nutraceutical, nutritional supplement and/or dietary supplement. Optionally, the formulation comprises one or more pharmaceutically acceptable carriers or excipients suitable for each formulation. It will be apparent to the person skilled in the art as to which excipients may be used for each formulation.

[0054] Unless the context clearly requires otherwise, throughout the description and the claims, the words 'comprise', 'comprising', and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is to say, in the sense of "including, but not limited to".

[0055] The term "about" is understood to refer to a range of +/- 10%, preferably +/- 5% or +/- 1% or, more preferably, +/- 0.1%.

[0056] Throughout this specification, unless specifically stated otherwise or the context requires otherwise, reference to a single step, composition of matter, group of steps or group of compositions of matter shall be taken to encompass one and a plurality (i.e. one or more) of those steps, compositions of matter, groups of steps or group of compositions of matter.

[0057] Each aspect of the invention described herein is to be applied mutatis mutandis to each and every aspect unless specifically stated otherwise.

[0058] Those skilled in the art will appreciate that the invention described herein is susceptible to variations and modifications other than those specifically described. It is to be understood that the invention includes all such variations and modifications. The invention also includes all of the steps, features, compositions and compounds referred to or indicated in this specification, individually or collectively, and any and all combinations or any two or more of said steps or features.

[0059] The present invention is not to be limited in scope by the specific embodiments described herein, which are intended for the purpose of exemplification only. Functionally equivalent products, compositions and methods are clearly within the scope of the invention, as described herein.

EXAMPLE

[0060] A research program aimed at a cohort of 60-75 year olds, measuring liver and kidney function after intervention with a daily micronutrient formulation (12.5 mg Vitamin B6, 200 pg Folic acid (Vitamin B9), 150 mg r,s-alpha Lipoic acid, 250 pg Vitamin B12 and 50 mg soy derived phosphatidylserine), was developed.

[0061] The following analyses were conducted for liver function and kidney function, providing an assessment of whether administration of a composition of the invention (in this instance, referred to as the Blackmores micronutrient formulation or "Blackmores") improved these variables relative to placebo.

[0062] Each section includes a table presenting the descriptive statistics for both the Blackmores micronutrient combination group and the placebo group at baseline. Furthermore, to analyse whether there is a significant mean difference between groups, a series of independent samples t-tests were also included. Comparisons of mean difference were calculated on difference scores (df), the descriptive statistics for which are also be presented.

Liver Function:

[0063] Several variables were measured at baseline and 3 month test times to provide an overall view of liver functioning. Table 1 presents the descriptive statistics and range of these variables, while Table 2 presents the descriptive statistics and independent groups t-tests results for difference scores as aforementioned, for both the Blackmores micronutrient combination and placebo groups. The results show a significant or trending reduction in several liver enzyme tests, suggesting improved liver health.

Table I Descriptive statistics for all measures of liver function at baseline for both treatment groups Variable Treatment N Minimum Maximum M SD Group Total Protein Blackmores 48 61.00 79.00 70.27 3.73 Placebo 48 63.00 83.00 69.69 3.67 Albumin Blackmores 48 34.00 45.00 40.25 2.65 Placebo 48 35.00 46.00 40.42 2.45 Alkaline Blackmores 48 38.00 117.00 79.60 2.73 Phosphotase Placebo 48 45.00 116.00 74.15 14.15 Gamma Blackmores 48 8.00 45.00 19.98 9.31 Glutamyltransferase Placebo 48 5.00 78.00 16.92 10.73 Asparate Blackmores 48 10.00 42.00 23.02 6.10 Aminotransferase Placebo 48 15.00 37.00 22.52 4.10

Alanine Blackmores 48 11.00 37.00 21.42 6.98 Aminotransferase Placebo 48 12.00 34.00 20.44 5.63

Table 2 Mean difference scores and independent samples t-tests for all liver function variables across groups Variable Treatment N M SD t df p Lower Upper group CI CI Total Protein Blackmores 34 -.06 3.50 .34 66 .737 -1.83 1.30 Placebo 34 .21 2.94 Albumin Blackmores 34 -.24 2.91 .51 66 .610 -1.58 .94 Placebo 34 .09 2.25 Alkaline Blackmores 34 -2.53 7.22 .58 66 .565 -4.58 2.52 Phosphatase Placebo 34 -1.50 7.46 Gamma Blackmores 34 -1.18 5.93 1.50 66 .140 -4.12 .59 Glutamyltransferase Placebo 34 .59 3.50 Asparate Blackmores 34 .15 4.45 2.73 66 .008 -5.40 -.83 Aminotransferase Placebo 34 3.26 4.97 Alanine Blackmores 34 -.74 6.09 4.67 66 .000 -9.99 -4.01 Aminotransferase Placebo 34 6.26 6.28

Kidney Function:

[0064] Table 3 presents the descriptive statistics for both treatment groups at baseline and Table 4 presents the descriptive statistics of the mean difference between the kidney function measures taken at the baseline and 3 month test times across groups, alongside, the associated independent samples t-tests assessing whether the difference between treatment groups' mean difference scores are statistically significant.

[0065] The results show a significant reduction in urea, indicating improved kidney function.

Table 3 Descriptive statistics for all measures of kidney function at baseline for both treatment groups Variable Treatment Group N Minimum Maximum M SD Potassium Blackmores 48 3.70 5.10 4.45 .32 Placebo 48 3.90 5.30 4.49 .28

Chloride Blackmores 48 100.00 110.00 105.52 2.22 Placebo 48 101.00 109.00 105.44 1.87 Bicarbonate Blackmores 48 28.00 33.00 30.10 1.52 Placebo 48 26.00 33.00 30.19 1.44 Urea Blackmores 48 3.30 9.00 6.15 1.22 Placebo 48 3.70 8.90 6.03 1.34 Creatinine Blackmores 48 50.00 115.00 76.04 14.72 Placebo 48 53.00 109.00 73.54 14.02 Glomreular Blackmores 46 54.00 90.00 77.84 10.06 Filtration Rate Placebo 46 59.00 90.00 79.87 9.07 Urate Blackmores 48 .13 .44 .30 .07 Placebo 48 19.00 .43 .31 .06 Calcium Blackmores 48 2.00 3.00 2.35 .07 Placebo 48 2.00 3.00 2.37 .09 Corr._Ca Blackmores 48 2.19 2.56 2.34 .07 Placebo 47 1.12 2.52 2.33 .19

Table 4 Mean difference scores and independent samples t-tests for all kidney function variables across groups Variable Treatment group N M SD t df p Lower Upper CI CI Potassium Blackmores 34 .05 .33 .60 66 .552 -.17 .22 Placebo 34 .00 .36 Chloride Blackmores 34 -.47 1.97 .37 66 .712 -1.13 .77 Placebo 34 -.29 1.95 Bicarbonate Blackmores 34 .15 1.96 .42 66 .679 -1.20 .78 Placebo 34 .35 2.13 Urea Blackmores 34 -.28 1.16 1.64 66 .106 -1.00 .10 Placebo 34 .17 1.11 Creatinine Blackmores 34 1.09 8.09 .94 66 .351 -4.96 1.79 Placebo 34 2.66 5.63 Glomerular Blackmores 32 .56 7.49 .86 63 .393 -1.98 4.99 Filtration Rate Placebo 33 -.94 6.56 Urate Blackmores 34 -.01 .04 .60 66 .549 -.02 .01 Placebo 34 -.00 .03 Calcium Blackmores 33 -.00 .08 .30 65 .768 -.04 .05 Placebo 34 -.01 .10 Corr. Ca Blackmores 33 .03 .18 1.23 65 .221 -.03 .11 Placebo 34 -.02 .09

Claims (5)

CLAIMS:

1. A method for maintaining/improving liver function and/or slowing age-related decline in liver function of an adult subject comprising administering a composition comprising:

(i) one or more B vitamins, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof; and

(ii) phosphatidylserine, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof; and

(iii) lipoic acid, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof,

in amounts and for a time sufficient to maintain/improve liver function and/or slow the age related decline in liver function of said adult subject.

2. Use of an effective amount of a combination of:

(i) one or more B vitamins, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof; and

(ii) phosphatidylserine, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof; and

(iii) lipoic acid, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof,

in the manufacture of a medicament, dietary/nutritional supplement, or nutraceutical for maintaining/improving liver function and/or slowing age-related decline in liver function of an adult subject.

3. A method for maintaining/improving kidney function and/or slowing age-related decline in kidney function of an adult subject comprising administering a composition comprising:

(i) one or more B vitamins, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof; and

(ii) phosphatidylserine, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof; and

(iii) lipoic acid, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof,

in amounts and for a time sufficient to maintain/improve kidney function and/or slow the age related decline in kidney function of said adult subject.

4. Use of an effective amount of a combination of:

(i) one or more B vitamins, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof; and

(ii) phosphatidylserine, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof; and

(iii) lipoic acid, or alternative form(s), derivative(s), or salt(s) thereof, or combinations thereof, and/or source(s) thereof,

in the manufacture of a medicament, dietary/nutritional supplement, or nutraceutical for maintaining/improving kidney function and/or slowing age-related decline in kidney function of an adult subject.

5. The method of claim 1 or claim 3, or the use of claim 2 or claim 4, wherein the adult subject is above the age of 30.