Effect of Different Dosages of Dark Chocolate on Arterial Blood Pressure in Cardiovascular High-risk Patients
Phase 4
Completed
- Conditions
- Hypertension
- Registration Number
- NCT00661986
- Lead Sponsor
- University of Leipzig
- Brief Summary
Low habitual intake of low-dose dark chocolate (6 g/day) has been shown to have a beneficial effect on arterial blood pressure in one previous study. The trial will assess if ingestion of a higher but still moderate dose (25 g/day) over 3 months will have a more pronounced effect. The population will consist of cardiovascular high-risk patients only (who will potentially benefit most from blood-pressure lowering).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
Inclusion Criteria
- age > 18 years
- mean ambulatory blood pressure 125-146 mmHg and/or 80-89 mmHg
- high cardiovascular risk profile (one or more of the following: CAD, PAD, carotid stenosis, diabetes)
- informed consent
Exclusion Criteria
- habituary intake of dark chocolate or cocoa products
- mean ambulatory blood pressure 147 mmHg or greater and/or 90 mmHg or greater
- pregnancy
- uncontrolled diabetes
- severe comorbidity
- change in blood pressure medication within last 6 weeks
- participation in another trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method change in mean ambulatory arterial blood pressure 3 months
- Secondary Outcome Measures
Name Time Method change in weight and BMI 3 months change in various lab parameters 3 months