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

Not Applicable

Completed

• Conditions: Cardiovascular Disease

• Registration Number: NCT01882881
• Lead Sponsor: Penn State University

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, 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2013-04-12
• Study First Submitted QC: 2013-06-18
• Study First Posted: 2013-06-21
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-16
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Lipoprotein class and subclass change	0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)	The VAP© Test provides a direct measure of the following lipid and lipoprotein classes and subclasses: LDL, Lp(a), IDL, LDL1, LDL2, LDL3, LDL4, HDL, HDL2, HDL3, VLDL, VLDL1+2, VLDL3, TC, TG, Non-HDL, Remnant Lipoproteins, ApoB100, and ApoA1.
Flow-mediated dilation change	0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
Lipid/lipoprotein change (standard panel)	0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)	Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides
24-hour ambulatory blood pressure change	0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)

Secondary Outcome Measures

Name	Time	Method
Plasma flavonoid change	0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
Serum C-reactive protein change	0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
LDL oxidation potential change (plasma)	0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)	The ex vivo resistance of LDL to Cu2+-mediated oxidation will be determined.
Serum insulin change	0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
Serum glucose change	0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
Urinary F2α-isoprostane change	0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
Plasma tocopherol change	0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)

Trial Locations

Locations (1)

Penn State Clinical Research Center, Noll Lab; 🇺🇸 University Park, Pennsylvania, United States