Skip to content

Chocolate blood pressure lowering trial

Chocolate Intervention to Reduce Chronically Elevated Blood Pressure Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24612
Enrollment
42
Registered
2008-09-23
Start date
2008-11-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Hypertension Prehypertension Lifestyle intervention

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. In between 2 weeks

Sponsors

Academic Medical Center University of Amsterdam The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Written informed consent 2. Age 40-70 years 3. Men and postmenopausal women 4. Blood pressure 130-159/85-99 mmHg 5. Maximum of 2 risk factors according to ESH 2007 guidelines 6. BMI > 18 and < 30 g/m2 7. Not on active anti-hypertensive treatment with at least six weeks since last use of antihypertensive medication 8.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 determined by examination at information meetings

Exclusion criteria

Exclusion criteria: 1. Previous cardiovascular event(s) (stroke, TIA, angina, myocardial infarction, heart failure) 2. Total cholesterol > 8.0 mmol/L 3. Diabetes mellitus, defined as fasting glucose > 7.0 mmol/L or use of glucose lowering drugs 4. Reported alcohol consumption > 28 alcohol units/week 5. Other diseases or oral medication affecting blood pressure 6. Currently on a medically prescribed diet, or slimming diet 7. Reported intense sporting activities > 10 h/w 8. Being lactose intolerant

Design outcomes

Primary

MeasureTime frame
The difference in blood pressure between the placebo treatment arm and the cocoa treatment arms as assessed by 24-hour ambulatory blood pressure measurement.

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. * Insulin sensitivity, lipid profile measured with standard laboratory techniques. * Platelet aggregation and function. * Mood and psychological well-being (via self-report questionnaires)

Contacts

Public ContactB. Bogaard, van den

Academic Medical Center Department of Vascular Medicine (room F4-255) P.O. Box 22660

B.vandenBogaard@amc.uva.nl /b.vandenbogaard@amc.nl+31 (0)20 5668675

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)