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

Study Overview
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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

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Control Capsules
* Dietary Supplement: Mars Cocoa Extract Capsules


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control, Flavanol-free intervention<br>Intake of flavanol-free, macro- and micro-nutrient matched control capsules | Dietary Supplement: Control Capsules<br>* 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).<br>|
| Active Comparator: CF intervention<br>Intake of capsules containing Mars Cocoa Extract Capsules manufactured by the Cocoapro® process and providing 500 mg of cocoa flavanols per capsule | Dietary Supplement: Mars Cocoa Extract Capsules<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood pressure | Blood pressure will be measured using standard techniques. | Baseline (day 0) and 6,12 and 14 weeks after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in platelet function | 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 6, 12 and 14 weeks after intervention | 
| Change in 24 h ambulatory blood pressure | 24 h ambulatory blood pressure will be measured using standard techniques. | Baseline (day 0) and 12 weeks after intervention | 
| Change in metabolic parameters in blood | Metabolic parameters determined in blood included: comprehensive metabolic panel, liver panel and cell blood counting. | Baseline (day 0) and 6, 12 and 14 weeks after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flavanols, Cocoa flavanols, Blood pressure, Platelet Function