Trial record 19 of 7753 for:    Open Studies | "Cardiovascular Diseases"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Penn State University
Sponsor:
Collaborators:
Almond Board of California
The Hershey Company
Information provided by (Responsible Party):
Penny Kris-Etherton, Penn State University
ClinicalTrials.gov Identifier:
NCT01882881
First received: April 12, 2013
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Cardiovascular Disease
Other: Healthy American Control Diet
Other: Dark Chocolate/Cocoa Diet
Other: Almond Diet
Other: Dark Chocolate/Cocoa + Almond Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Effects of Polyphenolic-rich Dark Chocolate/Cocoa and Almonds on Cardiovascular Disease Risk Factors

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides

  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
    The ex vivo resistance of LDL to Cu2+-mediated oxidation will be determined.

  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Healthy American Control Diet 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).
Experimental: Dark Chocolate/Cocoa Diet 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).
Experimental: Almond Diet 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.
Experimental: Dark Chocolate/Cocoa + Almond Diet 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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Overweight and obese (BMI ≥26, ≤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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01882881

Contacts
Contact: Claire E. Berryman, BS 1-866-778-3438 psudiet@psu.edu

Locations
United States, Pennsylvania
Penn State Clinical Research Center, Noll Lab Recruiting
University Park, Pennsylvania, United States, 16802
Contact: Claire E. Berryman, BS    866-778-3438    psudiet@gmail.com   
Sub-Investigator: Claire E. Berryman, BS         
Sub-Investigator: Jennifer A. Fleming, MS, RD         
Principal Investigator: Penny M. Kris-Etherton, PhD, RD         
Sponsors and Collaborators
Penn State University
Almond Board of California
The Hershey Company
Investigators
Principal Investigator: Penny M. Kris-Etherton, PhD, RD Penn State University
  More Information

No publications provided

Responsible Party: Penny Kris-Etherton, Distinguished Professor of Nutrition, Penn State University
ClinicalTrials.gov Identifier: NCT01882881     History of Changes
Other Study ID Numbers: PKE 107
Study First Received: April 12, 2013
Last Updated: June 23, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 26, 2014