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

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 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.

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

Conditions
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Healthy

Intervention / Treatment
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* 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cocoa Flavanol intake escalation<br>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<br>* 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.<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 14, 28, 42 and 56 days after intervention | 
| 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 14, 28, 42 and 56 days 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 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 | 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 | Methylxanthines determined in plasma include: caffeine, theobromine, paraxanthine and theophylline | Baseline (day 0) and 14, 28, 42 and 56 days 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