NCT01672840

Effects of Cocoa on Ambulatory Blood Pressure and Vascular Function in Patients With Stage I Hypertension

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Griffin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The proposed study Dose And Response to Cocoa (DARC), will examine variation in dose of cocoa-containing product consumption over an 8-week period and assess effects on blood pressure, endothelial function and arterial stiffness. The randomized, controlled, modified Latin square parallel design will compare the effects of two doses of cocoa consumption on blood pressure, endothelial function and arterial stiffness in 120 adults with stage 1 hypertension.

Detailed description

Hypothesis #1 To verify the efficacy of an 8-week course of cocoa-containing product consumption on blood pressure in adults with stage 1 hypertension. Specifically, to demonstrate at least 3.5 mmHg improvement in 24-hour mean systolic blood pressure following 8 weeks of treatment with cocoa- containing products when compared to placebo. Our hypothesis is that cocoa-containing product consumption will result in clinically significant improvement of systolic blood pressure at the conclusion of an 8-week course of treatment. Hypothesis #2 To identify a dose-response relationship in which increasingly higher doses of cocoa powder in cocoa-containing products will demonstrate correspondingly greater beneficial effects on blood pressure over an 8-week period in individuals with stage 1 hypertension. Specifically, to investigate the effects of the variation of dose of cocoa powder in cocoa-containing products (i.e. 5 grams or 10 grams of cocoa powder) for 8 weeks on blood pressure. We hypothesize that increasingly higher doses of cocoa powder in cocoa-containing products will demonstrate correspondingly greater beneficial effects on blood pressure. Hypothesis #3 To assess the effects of different doses of cocoa-containing product consumption over an 8-week period on 24-hour diastolic blood pressure, endothelial function, arterial stiffness, serum lipids, theobromine, CRP, glucose, insulin, body weight, and waist circumference in adults with stage 1 hypertension. We hypothesize that consumption of cocoa-containing products will lower diastolic blood pressure; improve endothelial function of our participants; reduce arterial stiffness; improve serum lipids; theobromine; and will have no clinically meaningful effects on body weight and waist circumference, CRP, glucose, or insulin.

Conditions

• Hypertension

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	5g Cocoa Consumption	Daily consumption of 10g Extra Dark cholocate and a beverage containing 2.5g of cocoa powder for 8 weeks
DIETARY_SUPPLEMENT	10g Cocoa Consumption	Daily consumption of 20g Extra Dark cholocate and two beverage containing 2.5g of cocoa powder each for 8 weeks

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2012-08-27
• Last updated: 2020-03-26

Locations

2 sites across 1 country: United States