Effects of Cocoa on Ambulatory Blood Pressure and Vascular Function in Patients With Stage I Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

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.
    

Intervention name(s): 5g Cocoa Consumption; 10g Cocoa Consumption
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Daily consumption of 10g Extra Dark cholocate and a beverage containing 2.5g of cocoa powder for 8 weeks; Daily consumption of 20g Extra Dark cholocate and two beverage containing 2.5g of cocoa powder each for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Stage 1 Hypertension; cocoa consumption; Blood pressure; Endothelial function; arterial stiffness