Effects of Cocoa on Ambulatory Blood Pressure and Vascular Function in Patients With Stage I Hypertension
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 2/7/2015 |
| Start Date: | July 2012 |
| End Date: | July 2014 |
| Contact: | Rockiy G. Ayettey, MPH |
| Email: | Rockiy.Ayettey@yalegriffinprc.org |
| Phone: | 203-732-1265 |
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.
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.
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
We found this trial at
2
sites
72 East Concord Street
Boston, Massachusetts 02118
Boston, Massachusetts 02118
(617) 638-5300
Boston University School of Medicine A leader in medical education and research, Boston University School...
Click here to add this to my saved trials
Click here to add this to my saved trials