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 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT04583657
Eligibility Criteria:
Inclusion Criteria:
* Woman or man, aged of 35 to 75 years
* Abdominal obesity : waist circumference for men \> 94cm and \> 80cm for women
* Practicing \< 2h of physical activity per week
Exclusion Criteria:
* Uncontrolled systolic blood pressure \> 160/100mmHg
* For premenopausal women: pregnant or lactating women
* For menopausal women: less than 6 months of menopause
* Perimenopausal women with symptoms
* Type II diabetes (fasted glycaemia ≥ 126mg/dl or HbA1c ≥ 6.5%), Type I diabetes
* Medical history or actual cardiovascular disease (myocardial infarction, angina, transient ischemic attack, lower limb arteriopathy)
* Familial history of premature cardiovascular incident (in male first degree relative \< 55 years and in female first degree relative \< 65 years; myocardial infarction, angina, transient ischemic attack, lower limb arteriopathy)
* Medical history or actual liver, pancreas, kidney, pulmonary or gastrointestinal problem
* Thyroid disorder
* Cancer \< 5 years before the screening visit
* Smokers or who have stopped smoking within 6 months before the screening visit
* Subject presenting allergy or food intolerance to eggs
* Subjects with psychiatric problems and/or using antipsychotics
* Drug addiction problem
* Recent change of body weight \> 5kg (\< 3 months before the screening visit)
* Within 3 months before the screening visit, change in the chronic (\> 7 days in a row) intake or dosage of drug(s) or product(s) modifying
* The glucose or lipid metabolism
* The blood pressure and heart rate
* Intestinal tolerance
* Hepatic, pancreas or kidney functions
* Satiety
* The inflammatory status
* Current or recent (\< 3 months before the screening visit) intake of dietary supplements rich in n-3 polyunsaturated fatty acid
* Vegan diet
* Consumption of fish \> 3 times per week
* Subjects who drink more than 3 glasses of alcohol per day (\> 30 g of alcohol per day)
* LDL \> 159 mg/dl or total cholesterol \> 239 mg/dl or triglyceride \> 200 mg/dl or HDL \< 40 mg/dl
* Docosahexaenoic acid in red blood cell phospholipids \> 8 %
* Subjects having participated to another clinical trial \< 1 month before the screening test visit
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT04583657
Study Brief:
Protocol Section:
NCT04583657