N/A
N=24
Effect Of Capros Supplementation On Cardiovascular Disease Risk Factors In Humans
Hyperlipidemia
Bottom Line
View on ClinicalTrials.gov: NCT01858376 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcome: Primary: Change From Baseline in Lipid Profile — 4.20; 3.37; -0.06 mg/dl
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Capros dietary supplement (Dietary_supplement)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Chandan K Sen
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Lipid Profile |
4.20; 3.37; -0.06 | — |
| SECONDARY Changes in High-Sensitivity C-reactive Protein |
0.07 | — |
| SECONDARY C-reactive Protein |
1.61 | — |
| SECONDARY Changes From Baseline in Platelet Aggregometry |
3.34; -9.56; 15.76 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01858376). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.