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

NACompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

August 31, 2016

Study Completion Date

August 31, 2016

Conditions
Cardiovascular Disease
Interventions
OTHER

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).

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).

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.

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.

Trial Locations (1)

16802

Penn State Clinical Research Center, Noll Lab, University Park

All Listed Sponsors
collaborator

Almond Board of California

OTHER

collaborator

The Hershey Company

INDUSTRY

lead

Penn State University

OTHER

NCT01882881 - Effects of Polyphenolic-rich Dark Chocolate/Cocoa and Almonds on Cardiovascular Disease Risk Factors | Biotech Hunter | Biotech Hunter