A Superior Vegetarian and Organic Product for Cardiovascular Health

Transcription

1 A Superior Vegetarian and Organic Product for Cardiovascular Health Introduction: Cardiovascular disease (CVD) is the leading cause of death amongst men and women in the United States. About 600,000 people die of heart disease in the United States every year that is 1 in every 4 deaths. CVD is very broadbased but can be broken down into two major categories: coronary artery disease and cerebrovascular disease. 1 Coronary artery disease occurs as a result of impeded blood flow through the arteries that supply the heart muscle. This can lead to myocardial infarction (heart attack), congestive heart failure, arrhythmias, and ultimately, cardiac arrest. Cerebrovascular disease is a result of occlusion of an artery that supplies blood to the brain and this type of occlusion can lead to a stroke. Some individuals can recover from these critical conditions; however, many times cardiovascular disease can lead to severe impairment and death. 2 Major risk factors for cardiovascular disease include hypertension, dyslipidemia, obesity, smoking, and Type 2 Diabetes mellitus. 2 There are many supplements in the market for cardiovascular support including omega-3 fatty acids (fish oil and krill oil), coenzyme Q10 (CoQ10), resveratrol and niacin. Omega-3 fatty acids have shown to decrease triglycerides significantly in numerous clinical trials; however, they have shown to increase total cholesterol and LDL. There is controversy regarding whether or not omega-3 fatty acids decrease the risk of cardiovascular mortality. 3 CoQ10 primarily acts as an antioxidant in the heart and prevents LDL from oxidizing. Due to CoQ10 s role in oxidative stress, energy production and stabilization, it is useful in preventing damage to the heart during periods of stress. Resveratrol belongs to a group of plant compounds called polyphenols. These compounds are thought to have antioxidant properties. Animal studies suggest that resveratrol might help protect the body against certain diseases, such as heart disease and cancer. However, very few studies have been conducted in humans and benefits cannot be confirmed. 4 Niacin, also known as vitamin B3, is naturally involved in carbohydrate and fat metabolism. It also acts as a potent vasodilator causing blood vessels to increase in diameter. Studies have shown significant reductions in LDL and triglycerides and increases HDL. Recently, the AIM-HIGH trial examined the effects of extended release niacin or placebo in patients with established heart disease, low HDL levels, and elevated triglyceride levels. 5 However, this trial was stopped early because niacin was showing no additional benefits over placebo and there was a small, unexplained increase in ischemic stroke in the niacin group. 5 Thus, efficacy of niacin is now being questioned and use may diminish due to these study results. CAPROS : The Next Generation Product for Cardiovascular Health CAPROS is a proprietary, multi-patented, standardized aqueous extract of Amla

2 (Phyllanthus emblica), which is an edible fruit that grows in India. Also known as Indian gooseberry, Amla has been used in India for thousands of years to promote cardiovascular health. CAPROS is a super antioxidant with an ORAC value of 47,110 µmoles TE/gm. Several clinical studies have shown the beneficial effects of CAPROS on endothelial function, reduction of cardiovascular risk factors, improvement of biomarkers of oxidative stress and inflammation, and inhibition of platelet aggregation. In addition, a recent in vivo study in rats has shown that CAPROS mitigates the effects of myocardial ischemia after reperfusion injury. CAPROS is suitable for solid dosage formulations; however, it is ideal for beverage formulations due to its nearly neutral taste, good flavor profile, aqueous solubility, and long term stability in solution. Reduce Cardiovascular Risk Factors 6,7,8 Several double-blind, placebo-controlled, human clinical trials were conducted that confirmed the ability of CAPROS to improve certain cardiovascular risk factors, including HDL, LDL, total cholesterol, triglycerides. Subjects taking the recommended dosage of 500mg twice daily for 12 weeks experienced significant decrease in LDL of 21% compared to placebo. HDL increased 15-18% in the CAPROS group compared to placebo. Total cholesterol and triglycerides decreased 11% and 19% respectively. All results were statistically significant compared to placebo. Improve Endothelial Function 6,7,8 Risk factors for cardiovascular disease, such as hypertension, hypercholesterolemia, and diabetes alter the function of the endothelium due to oxidant stress. Nitric oxide is one of the most important vasodilating substances released by the endothelium. In the presence of cardiovascular risk factors such as those listed above, the endothelium undergoes functional and structural alterations, thus losing its protective role and becoming a proatherosclerotic structure. Therefore, endothelial dysfunction is one of the early prognostic markers of atherosclerosis and may eventually result in cardiovascular disease. Therapies aimed at reducing oxidative stress would benefit patients who have risk factors for cardiovascular disease. CAPROS, due to its super antioxidant properties would be ideal for reducing oxidative stress and improving endothelial function. In several double-blind, placebo controlled human clinical trials, treatment with CAPROS 500mg twice daily for 12 weeks significantly reduced the reflection index (RI), which is a measure of endothelial function, compared to placebo. Endothelial function was defined as a 6% change in RI on

3 salbutamol challenge. Therefore, CAPROS significantly improved endothelial function. Improve Endothelial Biomarkers 6,7,8 Nitric oxide, malondialdehye, glutathione levels, and hscrp, which are all biomarkers of oxidative stress and inflammation, were also measured in these studies. C-reactive protein (CRP) is a major inflammatory factor produced by the liver during acute infection or inflammation. Levels of this protein are increased in endothelial dysfunction and atherogenesis; thus, suggesting that it is a predictor of early atherosclerotic damage. Malondialdehyde (MDA) is the end product of the radical-initiated oxidative decomposition of polyunsaturated fatty acids; therefore, it is used as a biomarker of oxidative stress. Clinical data have indicated that MDA-type epitopes are important in cardiovascular disease; thus, these antigens are key candidates for use in characterizing immune responses that are relevant to atherosclerosis. Glutathione is a naturally occurring antioxidant in the body and is essential for immune function, controlling inflammation, and mental and physical function. However, when the body is under oxidative stress, glutathione stores are depleted. Treatment with CAPROS 500mg twice daily for 12 weeks significantly reduced levels of malondialdehyde and hscrp. Glutathione levels and nitric oxide levels were significantly increased compared to placebo, thus suggesting an improvement in antioxidant status. Inhibit Platelet Aggregation 9 Platelet dysfunction is an important risk factor which can contribute to enhanced atherosclerosis, especially in diabetic patients. Platelets play a central role in atherogenesis and thrombotic complications; thus, inhibition of platelet aggregation through various drugs are pivotal in reducing ischemic events in diabetic patients. There are several different classes of antiplatelet drugs; however, aspirin and clopidogrel are the drugs of choice for secondary prevention of ischemic events in patients, including diabetic patients presenting with atherosclerotic cardiovascular disease. Although these medications are proven to be efficacious, clinical data shows the recurrence of ischemic events due to the development of antiplatelet drug resistance. In addition, the risk of adverse effects such as life threatening bleeding can limit the use of these medications

4 in certain patients. CAPROS, which does not have the bleeding risks associated with aspirin and clopidogrel, has shown platelet inhibition activity. In one randomized open label crossover study with type II diabetic patients, multiple dose administration of CAPROS 500mg twice daily resulted in a 36% inhibition of platelet aggregation while a combination of CAPROS with aspirin and CAPROS with clopidogrel resulted in 56% and 53% inhibition of platelet aggregation respectively. There were no major bleeding incidents reported in the study. treated group suggesting that CAPROS has a cardioprotective effect. CAPROS Mitigates Effects of Ischemia 10 A study recently completed in rats at the University of Connecticut shows the protective effects of CAPROS treatment on myocardial ischemia reperfusion injury. In this particular study, the rats were fed either with water or CAPROS for 30 days. After 30 days, myocardial ischemia was induced in both groups by LAD ligation for 45 minutes. Rats in the CAPROS treated group showed less damage to their myocardial tissue compared to the group without CAPROS treatment. For example, ejection fraction was preserved in the CAPROS treated group whereas the rats in the control group experienced a significant decline in EF to ~40%. Fibrosis of the myocardial tissue was also significantly decreased in the CAPROS Conclusion Risk factors such as dyslipidemia, hypertension, smoking, and type 2 diabetes are associated with impaired endothelial function. The intact endothelium promotes vasodilation via release of nitric oxide, which has been recognized as a key determinant of vascular homeostasis and is known to have antithrombotic properties. Decreased production of nitric oxide due to endothelial dysfunction can result in pathological consequences. Many medications are used to treat cardiovascular disease, including antihypertensives, antiplatelet agents, and antihyperlipidemics. However, these medications have many adverse effects and drug-drug interactions. Thus, the use of herbal supplements has become increasingly popular

5 in recent years. Approximately 80% of the population of developing countries relies on traditional medicines for their primary healthcare needs. CAPROS, which is the extract of the edible fruits of Phyllanthus emblica, has been proven safe and efficacious with multiple clinical trials in reducing cardiovascular risk factors, improving endothelial function, improving biomarkers of oxidative stress and inflammation, and inhibiting platelet aggregation. CAPROS is a vegan, pesticide free, solvent free, organic product with an ORAC value of 47,000 µmoles TE/g, thus making it a super antioxidant. In addition, it has excellent stability in powder form making it suitable for solid dosage formulations and beverage formulations. Therefore, CAPROS is the superior choice as a dietary supplement with cardiovascular health promoting benefits. References: 1) Go AS, Mozaffrian D, Roger VL, et al. Heart Disease and Stroke Statistics Update: a report from the American Heart Association. Circulation. 2014;128. 2) World Heart Federation (5 October 2011). "World Heart Federation: Cardiovascular disease risk factors". Retrieved 23 September ) Rizos EC, Ntzani EE, et al. Association Between Omega-3 Fatty Acid Supplementation and Risk of Major Cardiovascular Disease Events A Systematic Review and Meta- Analysis. JAMA. 2012;308(10): ) Agarwal B, Baur JA (Jan 2011). Resveratrol and Life Extension. Annals of the New York Academy of Sciences 1215: ) Teo KK, Goldstein LB, Chaitman BR, et al. Extended-release Niacin therapy and risk of ischemic stroke in patients with cardiovascular disease: the Atherothrombosis Intervention in Metabolic Syndrome with low HDL/high Triglycerides: Impact on Global Health Outcome (AIM-HIGH) trial. Stroke Oct; 44(10): ) Pingali, UR et al. Study of Capros 500mg and Placebo in modifying cardiovascular risk with special reference to endothelial dysfunction in patients with Type 2 Diabetes mellitus (Yet to be published). 7) Pingali UR, Nishat F, Nizampatnam M. Effects of Phyllantus emblica extract on endothelial dysfunction and biomarkers of oxidative stress in patients with type 2 diabetes mellitus: a randomized, doubleblind, placebo controlled study. Diabetes, Metabolic Syndrome, and Obesity: Targets and Therapy Jul(6): ) Pingali UR et al. Study of Capros 500mg and Placebo on Endothelial Dysfunction in Metabolic Syndrome (Yet to be published). 9) Pingali UR, Nishat F, Nizampatnam M. Study of Pharmacodynamic Interaction of Phyllanthus emblica extract with clopidogrel and ecospirin in patients with type 2 diabetes mellitus. Phytomedicine. 2013, ymed ) Maulik N et al. Protective Effects of Capros on Myocardial Ischemia

6 Reperfusion Injury (Yet to be published). Proudly Presented by: Natreon, Inc. 2-D Janine Place New Brunswick, NJ Tel: (732) Web: