Effect Of Capros Supplementation On Cardiovascular Disease Risk Factors In Humans

Not Applicable

Completed

Conditions: Hyperlipidemia

Interventions: Dietary Supplement: Capros dietary supplement

Registration Number: NCT01858376

Lead Sponsor: Chandan K Sen

Brief Summary: The hypothesis of this study is that the natural supplement Capros will decrease LDL levels, platelet aggregation, and serum concentrations of high sensitivity C-reactive protein in humans at risk for cardiovascular disease.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 24

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Capros dietary supplement	Capros dietary supplement	Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Lipid Profile	Baseline and 14 weeks	Blood lipid panel including HDL, LDL, total cholesterol. Looking at Baseline to 12 weeks on supplement with a two week washout period

Secondary Outcome Measures

Name	Time	Method
C-reactive Protein	Baseline and 14 weeks	C-reactive protein in blood as measured in a standard hospital laboratory. 12 weeks on supplementation data presented.
Changes From Baseline in Platelet Aggregometry	Baseline and 14 weeks	Adenosine Diphosphate (ADP), Arachidonic acid (AA), and Collagen (unsure about the specific type of collagen) agonists will be measured using optical platelet aggregometry. Looking at Baseline to 12 weeks on supplement with a two week washout period
Changes in High-Sensitivity C-reactive Protein	Baseline and 14 weeks	High-Sensitivity C-reactive Protein analysis in blood. Looking at Baseline to 12 weeks on supplement with a two week washout period