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

Sponsor

University of California, Davis (Other)

Overall Status

Completed

CT.gov ID

NCT02447770

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

18.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: Mars Cocoa Extract Capsules	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in blood pressure [Baseline (day 0) and 14, 28, 42 and 56 days after intervention]
Blood pressure will be measured using standard techniques.
Change in platelet function [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.
Change in metabolic parameters in blood [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.

Secondary Outcome Measures

Change in plasma concentration of cocoa flavanol metabolites [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
Change in plasma concentration of methylxanthines [Baseline (day 0) and 14, 28, 42 and 56 days after intervention]
Methylxanthines determined in plasma include: caffeine, theobromine, paraxanthine and theophylline

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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