|- candidate number||4105|
|- NTR Number||NTR1453|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||23-sep-2008|
|- Secondary IDs||08/237 AMC METC|
|- Public Title||Chocolate blood pressure lowering trial|
|- Scientific Title||Chocolate Intervention to Reduce Chronically Elevated Blood Pressure Trial|
|- hypothesis||Dark chocolate containing drinks lower blood pressure in prehypertensive and grade I hypertensive subjects with 2 or less additional cardiovascular risk factors and theobromine is an essential component of cocoa for obtaining a blood pressure lowering effect|
|- Healt Condition(s) or Problem(s) studied||Hypertension, Life style, Prehypertension, Intervention, Chocolate|
|- 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||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
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2008|
|- planned closingdate||1-apr-2009|
|- Target number of participants||42|
|- 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 washout periods.|
|- Primary outcome||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 outcome||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)
|- Timepoints||Aim: inclusion finalized by april 2008|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| B. Bogaard, van den|
|- CONTACT for SCIENTIFIC QUERIES|| B. Bogaard, van den|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC), Amsterdam, Unilever Research Vlaardingen, Unilever Health Institute|
|- Brief summary||Background: |
Persons with high-normal blood pressure or prehypertension and grade I hypertension have an increased risk for cardiovascular disease. According to current recommendations of the European Society of Hypertension (ESH) persons with high-normal blood pressure and grade I hypertension with a maximum of 2 additional risk factors and no evidence or history of cardiovascular disease are aimed at improving life style. Dark chocolate might be a possible non-pharmacological intervention to lower blood pressure in addition to life style advice.
To assess the effect of cocoa-containing drinks on blood pressure in untreated subjects with high normal blood pressure (prehypertension) or grade I hypertension as measured by 24-hours ambulatory blood pressure.
Randomized double-blind placebo-controlled cross-over trial.
42 healthy human volunteers, men and postmenopausal women, 40 - 70 yrs old, with high-normal blood pressure or grade I hypertension (blood pressure between 130-159 and/ or 85-99 mmHg) with a maximum of 2 risk factors according to the 2007 ESH guidelines and who have not received anti-hypertensive treatment the last 6 weeks.
Three weeks daily consumption of a cocoa drinks
Main study parameters/endpoints:
Difference in 24-hour ambulatory blood pressure for both cocoa treatments compared to the placebo treatment.
|- Main changes (audit trail)|
|- RECORD||23-sep-2008 - 10-jun-2010|