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 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT02243969
Eligibility Criteria:
Inclusion Criteria:
* Quetelet-index between 25-35 kg/m2
* High-normal blood pressure defined as systolic blood pressure between 130-139 mmHg and/or diastolic blood pressure between 85-89 mmHg. Or stage I hypertension defined as systolic blood pressure between 140-159 mmHg and/or diastolic blood pressure between 90-99 mmHg.
* Mean serum total cholesterol/HDL cholesterol ratio \< 8
* Mean serum triacylglycerol \< 4.5 mmol/L
* Mean plasma glucose \< 7.0 mmol/L
Exclusion Criteria:
* Unstable body weight (weight gain or loss \>2 kg in the past 3 months)
* Use of antihypertensive or anticoagulant medication
* Indication for treatment with medication according to the Standard for cardiovascular risk management of the Dutch general practitioners community (NHG)
* Usage of non-steroidal anti-inflammatory drugs (such as aspirin, ibuprofen, naproxen) and not able or willing to stop taking them from at least 4 weeks prior to the study
* Use of medication or a diet known to affect serum lipid or glucose metabolism
* Women with expected changes in the use of oral contraceptives or estrogen replacement therapy during the study period
* Women lactating, pregnant or intend to become pregnant during study
* Active cardiovascular disease like congestive heart failure or recent (\<6 months) event (acute myocardial infarction, cerebro vascular accident)
* Severe medical conditions that might interfere with the study such as diabetes mellitus, epilepsy, asthma, chronic obstructive pulmonary disease, inflammatory bowel diseases and rheumatoid arthritis
* Smoking or recently quit smoking (\<1 years)
* Abuse of drugs
* More than 21 alcohol consumptions per week for men and 14 consumptions for women
* Reported intense sporting activities \> 10 h/w
* Not possible or difficult to venipuncture as evidenced during the screening visits
* Use of an investigational product within the previous 30 days
* 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
* Not willing to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study and during the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT02243969
Study Brief:
Protocol Section:
NCT02243969