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:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-26 @ 10:36 AM
NCT ID:
NCT02664428
Eligibility Criteria:
Inclusion Criteria:
* male and female;
* age between 30 and 65 years;
* with BMI (body mass index, BMI) of between 20 and 29.9 kg/m2,
* total plasma cholesterol in the range 180-240 mg/dl.
Exclusion Criteria:
Subjects will be excluded from participation in the study if they meet one of the following exclusion criteria:
* fasting glucose\> 140 mg/dl;
* triglycerides\> 500 mg/dl;
* uncontrolled hypertension (BP \>160/100 mm Hg under antihypertensive therapy); cardiovascular disease (myocardial infarction, percutaneous transluminal coronary angioplasty or coronary artery bypass grafting, unstable angina pectoris, stoke, peripheral arterial disease);
* hypo or hyperthyroidism;
* acute inflammatory diseases;
* serious gastrointestinal disease;
* hypo- or hyperthyroidism;
* acute inflammatory diseases;
* severe gastrointestinal diseases;
* heart, liver, renal or pulmonary failure or other life threatening disease with prognosis \<5 years;
* chronic use of systemic corticosteroids, anti-coagulants, anti-inflammatory, or lipid lowering and anti-diabetics drugs;
* treatment within the previous 6 weeks with any medication that is known to affect lipoprotein levels or fecal microbiota (specifically, antibiotics);
* food intolerances;
* alcohol intake \>5 drinks per day or use of narcotic substances;
* use of antioxidant vitamin or mineral supplements;
* special diet;
* pregnancy;
* smoking.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT02664428
Study Brief:
Protocol Section:
NCT02664428