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

NCT ID: NCT01882881

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2016-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Healthy American Control Diet

Group Type: ACTIVE_COMPARATOR

Healthy American Control Diet

Intervention Type: 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).

Dark Chocolate/Cocoa Diet

Group Type: EXPERIMENTAL

Dark Chocolate/Cocoa Diet

Intervention Type: 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).

Almond Diet

Group Type: EXPERIMENTAL

Almond Diet

Intervention Type: 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.

Dark Chocolate/Cocoa + Almond Diet

Group Type: EXPERIMENTAL

Dark Chocolate/Cocoa + Almond Diet

Intervention Type: 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.

Interventions

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).

Intervention Type: OTHER

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).

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Almond Board of California

OTHER

Sponsor Role: collaborator

The Hershey Company

INDUSTRY

Sponsor Role: collaborator

Penn State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Penny M. Kris-Etherton, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Locations

Penn State Clinical Research Center, Noll Lab

University Park, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29187388 (View on PubMed)

Other Identifiers

PKE 107

Identifier Type: -

Identifier Source: org_study_id