An interventional study of Healthy American Control Diet and Dark Chocolate/Cocoa Diet in Cardiovascular Disease, sponsored by Penn State University. Completed at 1 site in United States. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-08-21.
Sponsored by Penn State University · Not applicable, Interventional, and Prevention
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.
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This study's enrollment of 48 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
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Counted across the registry records on this site, refreshed daily.
105-194 mg/dL for males; 98-190 mg/dL for females.
Exclusion Criteria:
Other: Healthy American Control Diet
Other: Dark Chocolate/Cocoa Diet
Other: Almond Diet
Other: Dark Chocolate/Cocoa + Almond 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).
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).
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.
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.
Lipid/lipoprotein change (standard panel)
Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides
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
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.
Time frame: 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
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)
The ex vivo resistance of LDL to Cu2+-mediated oxidation will be determined.
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)
PON1 activity change (serum)
Time frame: 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)
Time frame: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Penn State University