Healthy
Conditions
Keywords
Flavanols, Cocoa flavanols, Blood pressure, Platelet Function
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
Interventions
DIETARY_SUPPLEMENTControl 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).
DIETARY_SUPPLEMENTMars 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).
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood pressure | Baseline (day 0) and 6,12 and 14 weeks after intervention | Blood pressure will be measured using standard techniques. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in plasma concentration of cocoa flavanol metabolites | 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 |
| Change in plasma concentration of methylxanthines | Baseline (day 0) and 6, 12, and 14 weeks after intervention | Methylxanthines determined in plasma include: caffeine, theobromine, paraxanthine and theophylline |
Countries
United States
Outcome results
None listed