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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON32431
Enrollment
42
Registered
2008-09-26
Start date
2008-10-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

high blood pressure hypertension

Interventions

Three weeks daily consumption of a cocoa drink rich in flavanols and rich in theobromine, a cocoa drink rich in flavanols but low in theobromine and a placebo drink in random order.

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Difference in 24-hour ambulatory blood pressure for both cocoa treatments compared to the placebo treatment.

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)