Status:
COMPLETED
Effects of Cocoa Intake on Blood Pressure in Elderly Individuals With Mild Hypertension
Lead Sponsor:
University of Cologne
Conditions:
Hypertension
Eligibility:
All Genders
55-75 years
Phase:
PHASE1
Brief Summary
Regular intake of cocoa-containing foods is linked to a considerably lower cardiovascular and all-cause mortality in observational studies. Short-term intervention studies indicate that high doses of ...
Eligibility Criteria
Inclusion
- Subjects between the ages of 55 - 75 years in good general health with high normal blood pressure (between 130/80 and 140/90 mmHg) or mild hypertension (blood pressure between 140/90 and 160/100 mmHg)on no medication or nutritional supplements
- Non-manual workers with a household income \> 20,000 €/year
- Normal plasma lipids (total plasma cholesterol \< 6.18 mmol/L
- LDL \< 4.11 mmol/L
- HDL \> 0.9 mmol/L
- Triacylglycerols \< 1.8 mmol/L) and normal plasma glucose (fasting plasma glucose 4.2-6.4 mmol/L).
- If a subject's blood pressure exceeds 170/100 mmHg on a single visit, the subject will be withdrawn from the study and referred to appropriate antihypertensive therapy.
Exclusion
- Subjects are excluded if they have:
- 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.
- Subjects are excluded if they have:
- A body-mass index of more than 27.5 or less than 18.5 kg/m2
- Actively smoked tobacco within the last five years
- Regularly use medications
- Used any medication within the last two weeks before entry
- Use vitamin, mineral or polyphenol supplements or functional food.
- Subjects will be excluded if they are unable to give informed consent for all procedures; or subjects who are not capable or willing to appear for controlling visits.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00421499
Start Date
January 1 2005
End Date
May 1 2005
Last Update
January 12 2007
Active Locations (1)
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1
Department of Pharmacology, University of Cologne
Cologne, Germany, 50931