Effect Of Capros Supplementation On Cardiovascular Disease Risk Factors In Humans

A non-randomized, longitudinal study to determine the effect of Capros supplementation on a
lipid profile, platelet aggregation and high-sensitivity C - reactive protein in 30
volunteers at risk for cardiovascular disease.

-Herbal Polyphenols/Antioxidants: Role in Cardiovascular Disease Prevention: Phenolic
compounds are dietary antioxidants found in plants that are shown to inhibit LDL oxidation,
inhibit platelet aggregation and adhesion, decrease total and LDL cholesterol, and induce
endothelium-dependent vaso-relaxation. [Lapointe, Vita, and Mendes]. Epidemiologic studies
suggest that higher polyphenol intake from fruits and vegetables is associated with decreased
risk for cardiovascular disease. Among the numerous plausible mechanisms by which polyphenols
may offer cardiovascular protection, improvement of the endothelial function and inhibition
of angiogenesis and cell migration and proliferation in blood vessels have been the focuses
of recent studies. Antioxidants in polyphenols, in addition to protecting LDL cholesterol
against oxidation, may act at a vascular cell level by limiting cellular production of
reactive oxygen species, and, thus, cell-mediated LDL oxidation. In traditional Indian
medicine, the gooseberry (Phyllanthus emblica) has been used for thousands of years as an
effective source of polyphenols and antioxidants. "P. emblica is considered beneficial
against various diseases namely cancer, diabetes, liver treatment, and various other
diseases."[Hiraganahalli]. Capros®, from Natreon, Inc., is a cascading antioxidant ingredient
derived from Phyllanthus emblica. It has been used in cosmetics and food-and-beverage
formulations in many countries, and, based on extensive scientific research, also shows
particular promise as a dietary supplement.

Inclusion Criteria:

- Patients 21-70 years of age

- BMI 25-35

Exclusion Criteria:

- BMI > 35 OR < 25

- Smokers

- Individuals who are deemed unable to understand the procedures, risks and benefits of
the study, i.e. Informed consent will be excluded

- Females who are pregnant as well as individuals who are therapeutically
immuno-compromised will also be excluded in order to minimize the risk to such
individuals (and fetus) and to decrease statistical variability and to minimize
potential of confounders.

- Candidates for inclusion into the study will not include individuals as defined in 45
CFR 46 Subparts B, C and D, nor from any other population which may be considered
vulnerable. Pregnant women are excluded to minimize the risk to such individuals (and
fetus) and to decrease statistical variability and to minimize potential of
confounders.