Status:
COMPLETED
Effect Of Capros Supplementation On Cardiovascular Disease Risk Factors In Humans
Lead Sponsor:
Chandan K Sen
Collaborating Sponsors:
Natreon, Inc.
Conditions:
Hyperlipidemia
Eligibility:
All Genders
21-70 years
Phase:
NA
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...
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 c...
Eligibility Criteria
Inclusion
- Patients 21-70 years of age
- BMI 25-35
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01858376
Start Date
March 1 2013
End Date
January 1 2015
Last Update
July 27 2018
Active Locations (1)
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1
The Ohio State University
Columbus, Ohio, United States, 43210