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Completed

NCT Number: NCT02447783

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

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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Key information

Conditions

Healthy

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ragle Human Nutrition Research Center, Department of Nutrition at UC Davis

Davis, California, 95616, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control Capsules

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).

Mars Cocoa Extract Capsules

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).

Primary outcomes

  1. Change in blood pressure

    Time frame: Baseline (day 0) and 6,12 and 14 weeks after intervention

    Blood pressure will be measured using standard techniques.

Secondary outcomes

  1. Change in platelet function

    Time frame: 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.

  2. Change in 24 h ambulatory blood pressure

    Time frame: Baseline (day 0) and 12 weeks after intervention

    24 h ambulatory blood pressure will be measured using standard techniques.

  3. Change in metabolic parameters in blood

    Time frame: 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.

Other outcomes

  1. Change in plasma concentration of cocoa flavanol metabolites

    Time frame: Baseline (day 0) and 6, 12 and 14 weeks after intervention

    Cocoa flavanol metabolites in plasma include: structurally related (-)-epicatechin metabolites and 5-(3,4-dihydroxyphenyl)-4-valerolactone metabolites

  2. Change in plasma concentration of methylxanthines

    Time frame: Baseline (day 0) and 6, 12, and 14 weeks after intervention

    Methylxanthines determined in plasma include: caffeine, theobromine, paraxanthine and theophylline

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 19, 2015
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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