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

NCT01882881 | Completed

• 1 other identifier: PKE 107
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (4)

• Lipid/lipoprotein change (standard panel)

  Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides

  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

  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

  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

  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.

  0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)

Secondary Outcomes (7)

• 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)

• 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)

• Plasma flavonoid 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)

Other Outcomes (2)

• PON1 activity change (serum)

  0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)

• Ex vivo cholesterol efflux change (serum)

  0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)

Study Arms (4)

Healthy American Control Diet

ACTIVE COMPARATOR

Other: Healthy American Control Diet

Dark Chocolate/Cocoa Diet

EXPERIMENTAL

Other: Dark Chocolate/Cocoa Diet

Almond Diet

EXPERIMENTAL

Other: Almond Diet

Dark Chocolate/Cocoa + Almond Diet

EXPERIMENTAL

Other: Dark Chocolate/Cocoa + Almond Diet

Interventions

Healthy American Control Diet OTHER

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).

Healthy American Control Diet

Dark Chocolate/Cocoa Diet OTHER

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).

Dark Chocolate/Cocoa Diet

Almond Diet OTHER

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.

Almond Diet

Dark Chocolate/Cocoa + Almond Diet OTHER

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.

Dark Chocolate/Cocoa + Almond Diet

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Overweight and obese (BMI ≥25, ≤40 kg/m2)
• Moderately elevated LDL-C between the 25-95th percentile from NHANES:
• mg/dL for males; 98-190 mg/dL for females.

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead
• Almond Board of California: collaborator
• The Hershey Company: collaborator

Study Sites (1)

Penn State Clinical Research Center, Noll Lab

University Park, Pennsylvania, 16802, United States

Location

Related Publications (1)

• Lee Y, Berryman CE, West SG, Chen CO, Blumberg JB, Lapsley KG, Preston AG, Fleming JA, Kris-Etherton PM. Effects of Dark Chocolate and Almonds on Cardiovascular Risk Factors in Overweight and Obese Individuals: A Randomized Controlled-Feeding Trial. J Am Heart Assoc. 2017 Nov 29;6(12):e005162. doi: 10.1161/JAHA.116.005162.

  PMID: 29187388 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Chocolate

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Penny M. Kris-Etherton, PhD, RD

  Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2013
• First Posted: June 21, 2013
• Study Start: March 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

US (1)