Effects of Cocoa on Ambulatory Blood Pressure and Vascular Function in Patients With Stage I Hypertension
Completed · Not applicable
Conditions studied: Hypertension
In brief
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.
Key facts
- Study ID
- NCT01672840
- Run by
- Griffin Hospital
- People needed
- 120
- Starts
- 2012-07-01
- Expected to finish
- 2013-12-01
- Last updated by the study team
- 2020-03-26
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- men and women age 18-75 years
- stage 1 hypertension (i.e. 140-159/90-99 mmHg) without anti-hypertensive medication or with only one anti-hypertensive medicaion
- body mass index < 35 kg/m²
- willing to discontinue the use of chocolate/cocoa products at least 4 weeks prior to intervention.
You may not qualify if…
- anticipated inability to complete or comply with study protocol
- use of lipid-lowering or aspirin unless stable on medication for at least 1 month and willing to refrain from taking medication for 12 hours prior to endothelial function scanning
- severe hypertension (systolic blood pressure >160mmHg or diastolic blood pressure >100 mmHg), or use more than one anti-hypertensive medications
- allergic to cocoa products (chocolate or cocoa powder)
- regular use of vitamin C, vitamin E, fish oil, flax seed oil, omega-3 fatty acids, Coenzyme Q10, fiber supplements, garlic pills, arginine, red yeast rice, and/or any kind of antioxidant and unwilling to discontinue supplementation for at least 4 weeks prior to study initiation and for the study duration. Use of a multi-vitamin containing no more than two times the recommended daily allowance for vitamins C and E is permissible
- diagnosed eating disorder
- on any specific diet, weight control diet, and/or vegan diet
- substance abuse (chronic alcoholism and/or other chemical dependency)
- any unstable medical condition that would limit the ability of a subject to participate fully in the trial (e.g., cancer, AIDS, tuberculosis, psychotic disorder)
- current or impending pregnancy. In premenopausal women, pregnancy will be excluded by pregnancy test at the time of each study visit.
Where it is running
- Griffin Hospital — Derby, Connecticut, United States
- Boston University School of Medicine — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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