Hypertension
Conditions
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).
Interventions
DIETARY_SUPPLEMENTdark chocolate 6 g/day
dark chocolate 6 g/day
DIETARY_SUPPLEMENTdark chocolate 25 g/day
dark chocolate 25 g/day
Sponsors
University of Leipzig
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in mean ambulatory arterial blood pressure | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| change in weight and BMI | 3 months |
| change in various lab parameters | 3 months |
Outcome results
None listed