Status:
COMPLETED
Effects of Dark Chocolate on Insulin Sensitivity in People With High Blood Pressure
Lead Sponsor:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Hypertension
Eligibility:
All Genders
21-65 years
Phase:
PHASE1
Brief Summary
This study will examine whether dark chocolate affects the way patients with hypertension (high blood pressure) respond to insulin, a hormone secreted by the pancreas that regulates blood glucose (sug...
Detailed Description
Dark chocolate and other cocoa products contain antioxidants including the polyphenol epicatechin that have beneficial effects on vascular function. Oral consumption of dark chocolate lowers blood pre...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Hypertensive subjects between the ages of 21 - 65 years in good general health except for mild to moderate hypertension (blood pressure between 140/95 and 170/110 off medication), on no medication or nutritional supplements except for antihypertensive agents, anti-cholesterol drugs or birth control agents. Subjects will be taken off all antihypertensive OTC supplements and anti-cholesterol drugs for one week prior to study and for the duration of the study. Women on birth control will remain on their regime. During the time subjects receive no antihypertensive therapy, their blood pressure will be monitored at least daily (either at home, in the clinic, or at another convenient facility). If a subject's blood pressure exceeds 170/110 on three determinations over a period of at least 15 minutes, the subject will be withdrawn from the study and appropriate antihypertensive therapy resumed. In addition, if the subject's blood pressure exceeds 160/100 during measurements on three consecutive days, the subject will be withdrawn from the study and appropriate antihypertensive therapy resumed.
- EXCLUSION CRITERIA
- Subjects will be excluded if they have diabetes, pregnancy, liver disease, pulmonary disease, renal insufficiency, coronary heart disease, heart failure, peripheral vascular disease, coagulopathy, actively smoked tobacco within last two years, in treatment for any form of cancer, positive tests for HIV, hepatitis B or C, or take systemic corticosteroids. These conditions are all known to adversely influence insulin sensitivity.
- Subjects will be excluded if they have a history of malignant hypertension, aortic aneurysm or stroke.
- Subjects with known hypersensitivity to octafluoropropane or with known cardiac shunts will also be excluded from participating because of potential adverse effects from microbubble contrast agent.
- Subjects will be excluded if they are unable to give informed consent for all procedures.
- Children are excluded from this study because children are not typically hypertensive.
Exclusion
Key Trial Info
Start Date :
December 10 2004
Trial Type :
INTERVENTIONAL
End Date :
April 16 2009
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00099476
Start Date
December 10 2004
End Date
April 16 2009
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892