Chocolate Intervention to Reduce Chronically Elevated blood pressure trial* CIRCE trial

Conditions: high blood pressure
hypertension
10057166

Registration Number: NL-OMON32431

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 42

Inclusion Criteria

informed consent
age 40-70 years
men and postmenopausal women
blood pressure 130-159/85-99 mmHg
maximum of 2 risk factors according to ESH 2007 guidelines
BMI > 18 and < 30 g/m2
not on active anti-hypertensive treatment with at least six weeks since last use of antihypertensive medication
haematological and clinical chemical parameters within the normal reference range
willing to restrict daily intake of coffee below 4 cups and to refrain from dark chocolate and to refrain from supplements that contain polyphenols from the screening visit to the end of the study

Exclusion Criteria

previous cardiovascular event(s) (stroke, TIA, angina, myocardial infarction, heart failure)
total cholesterol > 8.0 mmol/L
diabetes mellitus, defined as fasting glucose > 7.0 mmol/L or use of glucose lowering drugs
reported alcohol consumption > 28 alcohol units/week
other diseases or oral medication affecting blood pressure
being an employee of the AMC
currently on a medically prescribed diet, or slimming diet
reported intense sporting activities > 10 h/w
being lactose intolerant

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Difference in 24-hour ambulatory blood pressure for both cocoa treatments<br /><br>compared to the placebo treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The difference between the placebo treatment arm and the cocoa treatment arms<br /><br>in:<br /><br>Augmentation index, central (aortic) blood pressure and pulse wave velocity as<br /><br>assessed by the Sphygmocor device.<br /><br>Systemic vascular resistance as assessed by Finapres.<br /><br>Endothelial function as assessed by Endopat2000<br /><br>Insulin sensitivity, lipid profile measured with standard laboratory<br /><br>techniques.<br /><br>Platelet aggregation and function.<br /><br>Mood and psychological well-being (via self-report questionnaires)</p><br>