BACKGROUND OF THE INVENTION

Aging is the progressive biological change in an organism that leads to an increased risk of debility, disease, and death. With aging, some physiological functions of organs are deleterious changes and resemble those occurring in disease conditions such as hypertension, hyperlipidemia, chronic coronary disease, cardiovascular disease, cancer and diabetes. Those diseases can be correlated with several aging-associated conditions. As the result of significant improvements in hygiene, education, medicine, healthy diet, lifestyle, and health care, the proportion of aged people is steadily increasing. Healthspan extension is a key objective, which is the achievement of optimal longevity with good health and quality of life. Anti-aging studies are gaining wide attention for their focus change from simply prolonging lifespan to increasing health span, which emphasizes quality of life.

There are many aging management goals with proposed interventions such as reduction of internal toxicity and polluted environmental influences, inclusion of appropriate exercise and stress mediation, and hormonal therapies, as well as dietary interventions such as adherence to nutrition maximization, glycation control, calorie restriction mimetic and anti-aging nutrient supplements. Other approaches in anti-aging pharmacology are the use of medications and drugs for treating various pathological conditions related to aging. Among them are metformin, statins, beta-blockers, thiazolidinediones, newer generation β-adrenergic receptor inhibitors, renin-angiotensin-aldosterone system inhibitors, as well as anti-inflammatory medications that appear to be the most promising drug candidates. One problem is that these substances are not used currently for treating age-related pathological conditions in the absence of clinical manifestations of illness, though they could, theoretically, become agents for preventing or treating other syndromes or conditions commonly associated with aging. Many of these substances were developed for the treatment of acute medical conditions and consist of engineered molecules and specially synthesized compounds that are not known in nature. For this reason, many of these compounds require extensive testing and regulatory approval processes that are focused on identifying safety and efficacy for the treatment of one particular condition. Because many of the conditions associated with aging are chronic, long-term degenerative conditions, these compounds are difficult or impossible to test in this context.

In addition, there are numerous anti-aging therapy approaches including the investigation of genomic instability, epigenetic deregulation, loss of proteostasis, mitochondrial dysfunction, cellular senescence, exhaustion of stem cells, inflammation, telomere shortening, autophagy, impaired stress resistance and deregulated nutrient signaling, methylation and other forms of epigenetic chemical modification to nucleotides, DNA replication and gene expression improvement at the cell level. These novel therapeutic strategies are being developed and the most promising among them are stem cell and gene therapy. However, due to insufficient knowledge regarding the potential side effects and safety of these technologies, general public and medical professionals are still concerned about their safety and effectiveness for longtime use. Moreover, because many of these phenomena have not been accurately correlated to clinical conditions associated with aging, identifying particular modifications at the level of the genome has not been accurately correlated with the observable manifestations of aging.

Medicinal herbs have been widely applied in different disease stages for prevention and intervention stages. Medicinal herb supplements have shown their multi-target properties and allow them to be potential anti-aging interventions in the prevention and treatment of aging-associated disorders. Therefore, the use of more traditional medicinal/pharmacological interventions can be considered as a reasonable alternative and a holistic approach in anti-aging research[1,2,3]. Moreover, many of these compounds have a long history of use by humans to treat a variety of chronic conditions and have well-established safety profiles in long-term use.

Herbal medicine has a long history of application in anti-age and anti-disease treatment. It is believed that many of the medicinal herbs have anti-aging properties. Dietary and natural food supplements are widely used by individuals for potential health benefits such as reduction in total cholesterol or low-density lipoprotein cholesterol (LDL-C), and reducing risk of cardiovascular disease. Knowing that it is essential to maintain high levels of antioxidants, hormonal precursors, and other agents, which decrease with age, supplementing and replenishing these agents is a main factor in the development of anti-aging products. Studies have shown that some medicinal herbs are effective in the intervention or prevention of aging-associated disorders, and can be assigned the term “nutraceutical”. Nutraceuticals can refer to a particular supplement or individual chemicals which are present in common foods, herbs or plants. A large number of nutraceuticals are beneficial phytonutrients. Phytonutrients are plant-based compounds that are generally considered to have a beneficial effect on health. Many nutraceuticals have been accepted to be beneficial because of their presumed safety and potential nutritional and therapeutic effects for anti-aging[1,2,3].

A large body of scientific evidence shows that nutritional supplementation can increase fat metabolism. There are several lipolytic supplements available on the market. Those natural ingredients, such as caffeine, green tea extract, L-carnitine,Garcinia cambogia(hydroxycitric acid), capsaicin,ginseng, taurine, silk peptides and octacosanol, all of which have shown scientific evidence of enhancing fat metabolism associated with improving endurance performance[4].

Controlled clinical trials show that Low Glycemic Index (GI) diets can lower cholesterol, improve blood sugar control, and insulin sensitivity in diabetics, and control body weight. A dietary supplement derived from the common white kidney bean (Phaseolus vulgaris) has been shown to inhibit alpha-amylase, the complex carbohydrate digesting enzyme. White kidney bean extract can effectively reduce the Glycemic Index (GI) of existing foods without modifying their ingredient profile. With the appropriate dose and formulation, the GI of white bread was significantly decreased by the addition of white bean extract in powder form. The inhibition of alpha-amylase may result in the lowering of the effective Glycemic Index (GI) of certain foods[5, 10].

The effects of catechins and epigallocatechin gallate (EGCG) on energy, lipid metabolism and cardiovascular disease have been examined in humans. The trials/research show that green tea extract high in catechins can reduce body fat and cardiovascular risks in humans. The results show that a greater decrease in systolic blood pressure (SBP), Low-density lipoprotein (LDL) cholesterol and decreases in body weight, body mass index, body fat ratio, body fat mass, waist circumference, hip circumference, visceral fat area, and subcutaneous fat area, were found in the catechin group compared with the control group. No adverse effect was found[6].

Chlorogenic acid (CGA) is the major hydroxycinnamic acid derivative present in green coffee beans. Human and animal studies have shown that chlorogenic acid and green coffee bean extracts (45-55% chlorogenic acid) enhance energy metabolism and expenditure, decrease blood lipid levels, improve glucose tolerance, and support weight management without cardiovascular effects. CGAs-enriched green coffee extracts have been postulated to decrease glucose absorption in the intestines, and modulate the activities of hepatic and pancreatic lipases actions, which could lead to an inhibition of fat accumulation and stimulation of lipid metabolism. CGA could modulate blood pressure possibly by promoting the effects of nitric oxide and by reducing blood homocysteine levels. CGAs have been demonstrated to have antioxidant activity by their ability to scavenge free radicals in vitro and increase the antioxidant capacity of plasma in vivo. The evidence from published RCTs suggests that CGA from green coffee bean intake causes statistically significant reductions in systolic and diastolic blood pressures[7,8,9].

The administration of GymnemaSylvestreleaf extracts have been found to show reduction in elevated serum triglyceride (TG), total cholesterol (TC), very low-density lipoprotein (VLDL) and low-density lipoprotein (LDL) cholesterol in dose dependent manner. The efficiency of this agent was almost similar to that of a standard lipid lowering agent clifibrate[11]. In addition to hypolipidemic activity, extract of G.Sylvestreleaves showed good antimicrobial activity againstBacillus pumilis, B. subtilis, Pseudomonas aeruginosaandStaphylococcus aureus[12]. Anti-Inflammatory activity and free radical scavenging activity was found from extract of G.Sylvestreleaves. The inhibitory effects of DPPH radicals and LDL oxidation were found with aqueous extract of G.sylvestre[13].

An epidemiological study (637 elderly >60 years of age) evaluated the associations of metabolic disorders and anthropometric and biochemical biomarkers of lipid, glucose and oxidative metabolism and the habitual ingestion of guaraná (Paullinia cupana, Mart. Var. sorbilis) by an elderly population. The case-controlled study found that those who habitually drank guarana (GI, n=421) exhibited lower waist circumference and lower cholesterol (total and LDL-c) levels. Additionally, a significant association was found between lower levels of advanced oxidative protein product (AOPP) and habitual guaraná consumption. A low prevalence of various metabolic disorders was associated with guaraná ingestion. The prevalence of hypertension, obesity and metabolic syndrome in the GI group was lower than the prevalence found in the control group. The results constitute the epidemiological study to suggest a potentially protective effect of habitual guaraná ingestion against metabolic in elderly subjects. The studies on phytochemicals, including Guarana (Paullinia cupana) seeds extract and vitamin B1 and vitamin B3, showed benefits to enhance metabolism, antioxidant activities and energy, and showed no adverse influence on protein, lipid and carbohydrate profiles[14,15,16].

The researchers suggest that diet-induced hypercholesterolemic atherosclerosis is associated with an increase in oxidative stress. Dandelion root and leaf could protect against oxidative stress-linked atherosclerosis and decrease the atherogenic index. The results show that dandelion reduced the extent of atherosclerosis by reducing oxidative stress and serum TC, TG, LDL-C and raising serum HDL-C. Dandelion is beneficial in preventing hypercholesterolemic atherosclerosis and reducing risk factors for coronary artery disease[17,18].

The combinations of herbal ingredients to enhance thermogenesis are reported. The addition of the flavonoids naringin and hesperidin enhance the non-stimulant thermogenic effect of p-synephrine. The combination of carotenoids and isoflavones with other thermogenic agents, caffeine with p-synephrine, offers great potential to enhance and facilitate energy metabolism, suggesting an enhanced thermogenic effect.

The immune system is the human body's defense mechanism that can distinguish itself from foreign pathogens to protect the host from invasion and infection. Mushrooms have a long history as a health food that has been used in medicine for treatment of the immune system. The ability of mushrooms to modulate immune functions and inhibit tumor growth is mainly contributed to their extracts or bioactive compounds, including polysaccharides, glycopeptide/protein complexes (polysaccharide-peptide/protein complexes), cordycepic acid, proteoglycans, proteins and triterpenoids. Mushroom polysaccharides in particular (1→3)-β-D-glucans and their peptide/protein derivatives are most extensively studied for their immunomodulatory and antitumor activities. Scientific studies have demonstrated that the 1,3 form of Beta Glucan, polysaccharides found in mushrooms possesses remarkable abilities to support both innate and adaptive immunity, including the enhancement of T-Cell and natural killer cell (NK) activity. The immune system consists of the innate and adaptive immunity. Because mushrooms and their bioactive compounds are related to their effects on immune effector cells, they can have immune responses both in the innate and adaptive immunity. The immune effector cells include hematopoietic stem cells, lymphocytes, macrophages, dendritic cells (DCs), NK cells, and T cells. The underlying mechanism mainly involves the interaction of membrane receptors in the immune cells with the mushroom polysaccharides, especially β-D-glucans that triggers a cascade of signaling pathways and cytokine release to activate the human immune cells[19,20,21,22,23].

Vitamins, minerals, and a range of other nutrients can deliver significant anti-aging benefits. Some of the most potent benefits of anti-aging therapies include efforts to minimize the risk of age-related diseases, maintain healthy blood pressure and reduce the risk of heart disease, improve health at a cellular level, combat oxidative stress, neutralize free radicals that cause oxidative damage and lead to cellular deterioration, support the immune system, and aid energy production. Vitamins that help with anti-aging include vitamins A, C, D, E, K, B3, B5, B6, B9, etc. Minerals that help with anti-aging include Ca, Mg, K, Se, Cr, Ze, Fe, etc[24].

Oxidative stress is involved in the pathophysiology of a number of inherited metabolic disorders. It plays an important role in various diseases that show a high worldwide prevalence, such as cancer, rheumatoid arthritis, asthma, diabetes, cardiovascular and neurodegenerative diseases, including atherosclerosis, Alzheimer's disease, and other age-related degenerative disorders. However, the clinical use of classical antioxidants in these diseases has been poorly evaluated and so far only minimal benefit has been demonstrated. The antioxidative and antimicrobial properties of many plant extracts are of great interest as natural additives. There is a growing tendency to replace synthetic antioxidants with natural antioxidative and antimicrobial agents of plant extracts.

Although there are many phytoconstituents that could combat health problems that are widely prevalent such as diabetes and obesity, a few of these phytoconstituents could simultaneously help as anti-aging therapies. In addition, a lot of thermogenic agents (such as high concentrations of ephedrine and caffeine) are applied, which can act through stimulation of the central nervous system, but may have adverse cardiovascular effects. Therefore there is increasing interest, and a great demand for, a new combination of herbal ingredients, vitamins and minerals, including natural antioxidants, natural anti-inflammatories, natural immunity stimulators and non-stimulatory thermogenic agents, that have safe health benefits such as cardiovascular protective, neuro and brain protective, hepatic protective, and gastrointestinal protective effects.

SUMMARY OF THE INVENTION

The present invention is methods and compositions to improve overall health and specifically to promote the reduction of biochemical mechanisms underlying the aging process. The compositions are formulated from the ingredients, and specific forms, derivatives, and relative quantities and/or concentrations to have a wide range of potential health benefits based in part on the us of these specific formulations of together with other compounds, such as specifically identified and other species phytochemicals that provide a non-pharmacological, non-invasive approach and non-stimulant nutraceuticals for treatment or prevention of some chronic diseases and anti-aging and may be currently administered over time without concerns of toxicity, long-term safety, cumulative side effects that may be associated with other pharmaceutical compounds.

The term “nutraceutical” was created from a combination of the words “nutrition” and “pharmaceutical” in 1989 by Stephen DeFelice, Md. A nutraceutical is any substance that may be considered a food, or part of a food, that provides medical or health benefits, including the prevention and/or treatment of a disease. Such products may range from isolated nutrients, dietary supplements and diets to genetically engineered “designer” foods, herbal products and processed foods. The nutraceutical in this present invention is based on herbal extracts and substances that were approved to contain effective phytochemicals and phytochemical activities. The compositions in the present invention also contain other dietary supplements such as vitamins, minerals, coenzymes, and amino acids having a synergistic effect with the phytochemical constituents to provide a therapeutically effective dosage of a composition having antiaging properties.

The compositions and methods of present invention areis designed to satisfy the anti-aging related needs of the growing aging population and purposes to improve a person's health and increase their healthspan by enhancing brain and cardiovascular system protection, maintain the normal function of the liver and gastrointestinal system, enhancing metabolism of energy, lipid, and carbohydrates, regulating mitochondrial oxidative metabolism, and preventing and decreasing obesity and chronic oxidative stress and diseases.

This design is best presented in theFIG. 1, “Some aging challenge problems and strategies on anti-aging”.

The present invention is based on therapeutic targets for anti-aging treatment with a combination of the following approaches:(1) Natural antioxidant and anti-microbial supplement treatment to reduce free radical-induced damage, and chronic inflammatory diseases/disorders.(2) Natural immunity supplement treatment to increase body defense systems.(3) Natural phytochemicals in a well selected combination to provide multiple functions to maintain health with beneficial effects and safety

More specifically, the present invention provides both a novel nutraceutical “Composition A” and a novel “Composition B.” Both Composition A and Composition B contain a selection of effective phytochemicals and other beneficial compounds that provide safe pharmacological actions and health benefits and may be administered either alone, sequentially or in combination as described below. The ingredients and compositions may optimize biological and pharmacological effects of the following select ingredients and may be practically used as a natural and safe food additive to replace the synthetic antibiotics and chemicals, and thereby reduce the high medicinal cost and incidence of side effects. The recitation of a specific identified set of compositions grouped within either of the defined Composition A or Composition B is open-ended and is not meant to preclude the addition of additional compositions within the scope of either of Composition A or Composition B, including combinations thereof within either set and substitutions for synonyms, analogues, or derivatives thereof as described herein except as specifically defined and claimed herein.

More specifically, substances and/or their derivatives which may be used in the Composition A include, but are not limited to: White Kidney Bean Extract Powder, Green Tea Extract Powder, Green Coffee Bean Extract Powder,Garcinia CambogiaExtract Powder, GymnemaSylvestreExtract Powder, L-Carnitine, Guarana Extract Powder, Ginger Root Powder, Dandelion Root Powder,CapsicumCayenne Powder, Licorice Root Powder, Ascorbic Acid, d-Calcium Pantothenate Powder, Pyridoxine HCl Powder, Potassium Chloride, Magnesium Carbonate, and Chromium Yeast Powder, analogues thereof and compositions thereof and not to the exclusion of other compounds.

Substances and/or their derivatives which may be used in the Composition B include, but are not limited to: Grape Seed Extract Powder,GinsengExtract Powder, Garlic Extract Powder, Rosehips Extract Powder, Green tea Extract (Decaf) Powder,AstragalusExtract Powder, Cat's Claw Extract Powder, Beta Glucan Yeast Powder, Reishi Extract Powder, Shitake Extract Powder, Maitake Extract Powder, Agricus blazei Extract Powder, Turkey Tail Extract Powder,CordycepsExtract Powder, and CoQ10, analogues thereof and compositions thereof and not to the exclusion of other compounds.

