Effect of Long Term Cocoa Flavanol Intake on Blood Pressure and Platelet Function in Healthy Adults, Part 2

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-12-31

Brief Summary

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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 long term consumptions of cocoa flavanols on blood pressure, platelet function and other metabolic parameters in healthy humans. This study is a continuation of a previous study investigating the consumptions of increasing amounts of cocoa flavanols on blood pressure, platelet function and other metabolic parameters in healthy humans

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control, Flavanol-free intervention

Intake of flavanol-free, macro- and micro-nutrient matched control capsules

Group Type PLACEBO_COMPARATOR

Control Capsules

Intervention Type DIETARY_SUPPLEMENT

Cocoa-based, flavanol-free, control-matched capsules consumed for 12 weeks (Week 1: 2 capsules/day; Week 2: 3 capsules/day; Week 3-12: 4 capsules/day; Week 12-14: no capsule intake).

CF intervention

Intake of capsules containing Mars Cocoa Extract Capsules manufactured by the Cocoapro® process and providing 500 mg of cocoa flavanols per capsule

Group Type ACTIVE_COMPARATOR

Mars Cocoa Extract Capsules

Intervention Type DIETARY_SUPPLEMENT

Capsules containing Mars Cocoa Extract manufactured by the Cocoapro® process and containing 500 mg of cocoa flavanols per capsule consumed for 12 weeks (Week 1: 2 capsules/day; Week 2: 3 capsules/day; Week 3-12: 4 capsules/day; Week 12-14: no capsule intake).

Interventions

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Control Capsules

Cocoa-based, flavanol-free, control-matched capsules consumed for 12 weeks (Week 1: 2 capsules/day; Week 2: 3 capsules/day; Week 3-12: 4 capsules/day; Week 12-14: no capsule intake).

Intervention Type DIETARY_SUPPLEMENT

Mars Cocoa Extract Capsules

Capsules containing Mars Cocoa Extract manufactured by the Cocoapro® process and containing 500 mg of cocoa flavanols per capsule consumed for 12 weeks (Week 1: 2 capsules/day; Week 2: 3 capsules/day; Week 3-12: 4 capsules/day; Week 12-14: no capsule intake).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes