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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Control Capsules; Dietary Supplement: Mars Cocoa Extract Capsules

• Registration Number: NCT02447783
• Lead Sponsor: University of California, Davis

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 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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2015-05-15
• Study First Submitted QC: 2015-05-18
• Study First Posted: 2015-05-19
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-24
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control, Flavanol-free intervention	Control Capsules	Intake of flavanol-free, macro- and micro-nutrient matched control capsules
CF intervention	Mars Cocoa Extract Capsules	Intake of capsules containing Mars Cocoa Extract Capsules manufactured by the Cocoapro® process and providing 500 mg of cocoa flavanols per capsule

Primary Outcome Measures

Name	Time	Method
Change in blood pressure	Baseline (day 0) and 6,12 and 14 weeks after intervention	Blood pressure will be measured using standard techniques.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ragle Human Nutrition Research Center, Department of Nutrition at UC Davis; 🇺🇸 Davis, California, United States