Status:
COMPLETED
Acute Hemodynamic Effects of Cocoa Polyphenols in Subjects With Hypertension and Optimal Blood Pressure
Lead Sponsor:
University of Cologne
Conditions:
Hypertension
Eligibility:
All Genders
50-75 years
Phase:
PHASE1
Brief Summary
Intake of cocoa-containing foods has been found to lower blood pressure (BP) in several clinical trials. It is supposed that the cocoa polyphenols represent the active principle, lowering BP by increa...
Eligibility Criteria
Inclusion
- Unpaid volunteers of both sex between 50 and 75 years of age in good general health.
- Diagnosis of stage 1 essential hypertension (BP between 140/90 and 160/100 mmHg) or optimal BP below 120/80) and stable BP values.
- No antihypertensive medications or nutritional supplements.
- Non-manual workers or pensioners of higher socioeconomic status (household income of more than 20,000 €/year)
- Leisure physical activity of less than 7 METs per week
- Normal levels of plasma lipids and plasma glucose.
Exclusion
- Cardiovascular diseases (other than hypertension).
- Diabetes mellitus.
- Hyper-/dyslipidemia.
- Gastrointestinal diseases
- Hepatic and renal disorders
- Pulmonary diseases.
- Coagulopathy.
- Cancer.
- Psychiatric disorders.
- Alcohol or drug dependence.
- Seizure disorders.
- History of organ transplantation.
- Surgery within the last 12 months.
- Positive tests for HIV, hepatitis B or C.
- Body-mass index of more than 27.5 or less than 18.5 kg/m2
- Active smokers of tobacco within the last five years.
- Regular users of medications.
- Use of any medication within the last two weeks before entry.
- Users of vitamin, mineral or polyphenol supplements or other bioactive food supplements.
- Regular consumers of chocolate or other cocoa products of more than 1 serving per week.
- Subjects will be excluded if they are unable to give informed consent for all procedures. Subjects who are not capable or willing to attend to all interventions will be withdrawn.
- Subjects will be withdrawn if the allocation concealment is disclosed.
- Subjects will be withdrawn if any adverse events requiring further monitoring or medical treatment occur.
- A systolic BP \>170 mmHg or \<100 mmHg or a diastolic BP \>110 mmHg or \<50 mmHg at a single determination will result in immediate withdrawal of the participant from the study and the appropriate treatment will be resumed.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00654862
Start Date
October 1 2007
Last Update
February 18 2009
Active Locations (1)
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1
Department of Pharmacology, University of Cologne
Cologne, Germany, D-50931