Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2025-12-24 @ 11:50 AM
NCT ID:
NCT01364961
Eligibility Criteria:
Inclusion Criteria:
* aged between 45 and 70 years
* HDL-C \<1.0 mmol/L (men)
* HDL-C \<1.3 mmol/L (women)
* serum total cholesterol \<8.0 mmol/L
* plasma glucose \<7.0 mmol/L
* BMI between 25 - 35 kg/m2
* non-smoking
* willingness to abstain from resveratrol rich products from two weeks prior to the study and the duration of the study:
* grapes and grape juice
* wine (red and white)
* all berries
* peanuts
* peanut butter
* soy (products)
* pomegranate
Exclusion Criteria:
* unstable body weight (weight gain or loss \>3 kg in the past 3 months)
* indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus
* use of medication or a medically-prescribed diet known to affect serum lipid or glucose metabolism
* Active cardiovascular disease (for instance congestive heart failure) or recent (\<6 months) event, such as acute myocardial infarction or cerebro-vascular accident
* not willing to stop the consumption of vitamin supplements, fish oil capsules or products rich in plant stanol or sterol esters 3 weeks before the start of the study
* men: consumption of \>21 glasses of alcohol-containing drinks per week women: consumption of \>14 glasses of alcohol-containing drinks per week
* abuse of drugs
* pregnant or breastfeeding women
* participation in another biomedical study within 1 month prior to the screening visit
* having donated blood (as blood donor) within 1 month prior to the screening visit or planning to do so during the study
* impossible or difficult to puncture as evidenced during the screening visits
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
70 Years
Study:
NCT01364961
Study Brief:
Protocol Section:
NCT01364961