Effects of Polyphenolic-rich Dark Chocolate/Cocoa and Almonds on Cardiovascular Disease Risk Factors (CAS)

The Pennsylvania State University (PENNSTATE)

Status: Completed

Conditions: Cardiovascular Disease

Treatments: Other: Healthy American Control Diet; Other: Almond Diet; Other: Dark Chocolate/Cocoa + Almond Diet; Other: Dark Chocolate/Cocoa Diet

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01882881

PKE 107

Details and patient eligibility

About

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, inflammatory status, blood pressure and arterial health. It is hypothesized that dark chocolate/cocoa and/or almonds will favorably affect lipids, lipoproteins, antioxidants, inflammatory status, blood pressure and arterial health compared to a healthy American control diet; however, the effects will be greater when dark chocolate/cocoa and almonds are consumed together versus consumption of each food individually.

Enrollment: 48 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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48 participants in 4 patient groups

Healthy American Control Diet

Active Comparator group

Treatment:

Other: Healthy American Control Diet

Dark Chocolate/Cocoa Diet

Experimental group

Treatment:

Other: Dark Chocolate/Cocoa Diet

Almond Diet

Experimental group

Treatment:

Other: Almond Diet

Dark Chocolate/Cocoa + Almond Diet

Experimental group

Treatment:

Other: Dark Chocolate/Cocoa + Almond Diet