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Completed

NCT Number: NCT01882881

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

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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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Clinical Research Center, Noll Lab

University Park, Pennsylvania, 16802, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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).

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.

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.

Primary outcomes

  1. 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)

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

  2. 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)

  3. 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)

  4. 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)

    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.

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

    The ex vivo resistance of LDL to Cu2+-mediated oxidation will be determined.

  6. 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)

  7. 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)

Other outcomes

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • Almond Board of California
  • The Hershey Company

Registry information

Acronym: CAS

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jun 21, 2013
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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