Effect of Long Term Cocoa Flavanol Intake on Blood Pressure and Platelet Function in Healthy Adults, Part 1

May 26, 2017 updated by: University of California, Davis
Flavanols are plant-derived compounds commonly present in the human diet. Examples of flavanol-containing foods and beverages are apples, chocolate, tea, wine, berries, pomegranate and nuts. The consumption of flavanol-containing foods and beverages has been associated with improvements in cardiovascular health. In this study, the investigators hope to learn more about the effects of the consumption of increasing amounts of cocoa flavanols on blood pressure, platelet function and other metabolic parameters in healthy humans. This study was followed by a second study that aimed at investigating the effects of long term consumptions of cocoa flavanols on blood pressure, platelet function and other metabolic parameters in healthy humans.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Davis, California, United States, 95616
        • Ragle Human Nutrition Research Center, Department of Nutrition at UC Davis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 30-55 years old
  • A normal blood chemistry and liver function
  • BMI < 30 kg/m2
  • previously consumed cocoa and peanut products, with no adverse reactions

Exclusion Criteria:

  • A history of cardiovascular disease, stroke, hypertension, renal, hepatic, or thyroid disease, GI tract disorders, previous GI surgery, metabolic syndrome, diabetes, taking cholesterol-lowering medication, hormone replacement therapy, antioxidant supplements, on aspirin therapy or taking anticoagulants, or on a medically prescribed diet.
  • Allergies to nuts, cocoa and chocolate products
  • Vegetarian, Vegan, food faddists, individuals using non-traditional diets, on a weight loss diet or using herbal dietary supplements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cocoa Flavanol intake escalation
Ingestion of increasing number of capsules containing Mars Cocoa Extract manufactured by the Cocoapro® process (500 mg of cocoa flavanols/capsule) during 6 weeks followed by a 2 week of washout (no capsule intake)
Dietary supplement: Mars Cocoa Extract Capsules
Capsules containing Mars Cocoa Extract manufactured by the Cocoapro® process, providing 500 mg of cocoa flavanols per capsule: 1000 mg of cocoa flavanols consumed daily during week 1 and 2, 1500 mg of cocoa flavanols consumed daily during week 3 and 4, and 2000 mg of cocoa flavanols consumed daily during week 5 and 6, and no capsule consumed (washout) during week 7 and 8.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in blood pressure
Time Frame: Baseline (day 0) and 14, 28, 42 and 56 days after intervention
Blood pressure will be measured using standard techniques.
Baseline (day 0) and 14, 28, 42 and 56 days after intervention
Change in platelet function
Time Frame: Baseline and 14, 28, 42 and 56 days after intervention
Platelet function will be determined using the PFA-100® analyzer (Dade Behring International, Miami, FL) with collagen-epinephrine (CEPI)- and collagen-ADP (CADP) stimulation.
Baseline and 14, 28, 42 and 56 days after intervention
Change in metabolic parameters in blood
Time Frame: Baseline (day 0) and 14, 28, 42 and 56 days after intervention
Metabolic parameters determined in blood included: comprehensive metabolic panel, liver panel and cell blood counting.
Baseline (day 0) and 14, 28, 42 and 56 days after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in plasma concentration of cocoa flavanol metabolites
Time Frame: Baseline (day 0) and 14, 28, 42 and 56 days after intervention
Cocoa flavanol metabolites in plasma include: structurally related (-)-epicatechin metabolites and 5-(3,4-dihydroxyphenyl)-4-valerolactone metabolites
Baseline (day 0) and 14, 28, 42 and 56 days after intervention
Change in plasma concentration of methylxanthines
Time Frame: Baseline (day 0) and 14, 28, 42 and 56 days after intervention
Methylxanthines determined in plasma include: caffeine, theobromine, paraxanthine and theophylline
Baseline (day 0) and 14, 28, 42 and 56 days after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

May 15, 2015

First Submitted That Met QC Criteria

May 18, 2015

First Posted (Estimate)

May 19, 2015

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 26, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 311497
  • 311497-I (Other Identifier: UC Davis)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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