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

University of California (UC) Davis

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Control Capsules; Dietary Supplement: Mars Cocoa Extract Capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT02447783

311497-II (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 75 patients

Sex: All

Ages: 30 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

75 participants in 2 patient groups, including a placebo group

Control, Flavanol-free intervention

Placebo Comparator group

Description:

Intake of flavanol-free, macro- and micro-nutrient matched control capsules

Treatment:

Dietary Supplement: Control Capsules

CF intervention

Active Comparator group

Description:

Intake of capsules containing Mars Cocoa Extract Capsules manufactured by the Cocoapro® process and providing 500 mg of cocoa flavanols per capsule

Treatment:

Dietary Supplement: Mars Cocoa Extract Capsules