Status:
COMPLETED
Effects of Polyphenolic-rich Dark Chocolate/Cocoa and Almonds on Cardiovascular Disease Risk Factors
Lead Sponsor:
Penn State University
Collaborating Sponsors:
Almond Board of California
The Hershey Company
Conditions:
Cardiovascular Disease
Eligibility:
All Genders
30-70 years
Phase:
NA
Brief Summary
The purpose of this study is to investigate the individual and combined effects of dark chocolate/cocoa and almonds on lipids, lipoproteins, antioxidant defense, lipid peroxidation, phenolic acids, in...
Eligibility Criteria
Inclusion
- Overweight and obese (BMI ≥25, ≤40 kg/m2)
- Moderately elevated LDL-C between the 25-95th percentile from NHANES:
- 105-194 mg/dL for males; 98-190 mg/dL for females.
Exclusion
- Tobacco use
- Systolic blood pressure ≥159 mm Hg
- Diastolic blood pressure ≥ 99 mm Hg
- A history of myocardial infarction, stroke, diabetes mellitus, liver disease, kidney disease, and thyroid disease (unless controlled on meds)
- Blood pressure or cholesterol-lowering medication use
- Refusal to discontinue intake of putative cholesterol-lowering supplements (e.g. psyllium, fish oil, soy lecithin, niacin, fiber, flax, stanols/sterols)
- Vegetarianism or dietary practices that are inconsistent with the test diets
- Nut allergies
- Refusal to discontinue nutritional supplements, herbs, or vitamins
- History of inflammatory gastrointestinal disease
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01882881
Start Date
March 1 2012
End Date
August 1 2016
Last Update
August 21 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Penn State Clinical Research Center, Noll Lab
University Park, Pennsylvania, United States, 16802