Overview

This trial is active, not recruiting.

Condition cardiovascular disease
Treatments healthy american control diet, dark chocolate/cocoa diet, almond diet, dark chocolate/cocoa + almond diet
Sponsor Penn State University
Collaborator Almond Board of California
Start date March 2012
End date August 2016
Trial size 48 participants
Trial identifier NCT01882881, PKE 107

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (investigator)
Primary purpose prevention
Arm
(Active Comparator)
healthy american control diet
The Control Diet will be comprised of the same foods as the test diets except for the isocaloric substitution of almonds and/or dark chocolate and cocoa for sources of saturated fat; an approximate 250 kcal substitution. In an effort to keep all the diets consistent (except for the specific foods to be tested), the Control Diet will be slightly higher in fiber (20-25g) and lower in cholesterol (~250 mg) than the typical consumption practices (15g and 278 mg, respectively).
(Experimental)
dark chocolate/cocoa diet
The Dark Chocolate/Cocoa Diet will include a daily hot cocoa beverage containing 11g of natural cocoa powder and 6 pieces of Hershey's Bliss Dark Chocolate (43g of dark chocolate). This amount of dark chocolate and cocoa will allow for the isocaloric substitution with 1.5oz almonds. The total diet will provide ~33% of calories from fat. The SFA (~12%) in the Dark Chocolate/Cocoa Diet will match that of the Control Diet and be slightly higher than the Almond Diet, however the saturated fat will be comprised largely of stearic acid from the dark chocolate; cholesterol will be ≤200 mg/day. The fiber in the Dark Chocolate/Cocoa Diet will be higher than both the Control and Almond Diets due to the fiber content of the dark chocolate (~9g).
(Experimental)
almond diet
The Almond Diet will include 1.5 oz of almonds daily and provide ~34% of calories from fat. The Almond Diet will be lower in SFA than the Control and Dark Chocolate/Cocoa Diets, containing ~ 8-9% calories from SFA. In addition, both almond containing diets will be slightly higher in MUFA and PUFA than the Control and Dark Chocolate/Cocoa Diets, as a result of the nutrient profile of the almonds. Cholesterol will be ≤200 mg/day; fiber will be increased compared to the Control Diet due to the inclusion of almonds.
(Experimental)
dark chocolate/cocoa + almond diet
This diet is designed to test the additive effects of combining consumption of dark chocolate and cocoa with almonds. The diet will include the same hot cocoa beverage (11g) and dark chocolate pieces (43g) plus 1.5 oz of almonds. Additional high saturated fat foods are removed from the Control Diet to account for both the dark chocolate and almonds. As a result, the total fat will be similar to the other three test diets at ~34-35% and the SFA will match that of the Almond Diet at ~8-9%. The fiber content of this diet will be highest (~35g); cholesterol will remain ≤200 mg/day.

Primary Outcomes

Measure
Lipid/lipoprotein change (standard panel)
time frame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
24-hour ambulatory blood pressure change
time frame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
Flow-mediated dilation change
time frame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
Lipoprotein class and subclass change
time frame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)

Secondary Outcomes

Measure
Serum C-reactive protein change
time frame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
Serum insulin change
time frame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
Serum glucose change
time frame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
Plasma flavonoid change
time frame: 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)
time frame: 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
time frame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
Plasma tocopherol change
time frame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)

Eligibility Criteria

Male or female participants from 30 years up to 70 years old.

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

Additional Information

Official title Effects of Polyphenolic-rich Dark Chocolate/Cocoa and Almonds on Cardiovascular Disease Risk Factors
Principal investigator Penny M. Kris-Etherton, PhD, RD
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Penn State University.