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 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT05427604
Eligibility Criteria:
Inclusion Criteria:
* Woman or man, aged of 18 to 65 years;
* Body mass index between 20 and 30 kg/m2;
* For women: use of effective contraception;
* Provision of signed and dated informed consent form;
* Stated willingness to comply with all study procedures and availability for the duration of the study.
Exclusion Criteria:
* Uncontrolled systolic blood pressure \> 160/100 mmHg;
* For premenopausal women: pregnant women or women planning to get pregnant within 3 months or lactating women;
* For menopausal women: less than 6 months of menopause;
* Type II diabetes (controlled or uncontrolled), Type I diabetes;
* Medical history or actual severe psychiatric, severe neurologic, severe hepatic, severe pancreatic, severe kidney, severe pulmonary, severe cardiovascular or severe gastrointestinal problem;
* Thyroid disorder;
* Cancer \< 3 years before the inclusion;
* Consumption of drug under prescription or over-the-counter drug or dietary supplement (including n-3 PUFA) within 1 month before the inclusion (excepted contraception);
* Consumption of fish or of omega-3 enriched eggs \> 2 times per week within 1 month before the inclusion;
* Subjects who are not able to understand and follow study procedures;
* Drug addiction problem (occasional or regular consumption);
* Women who drink more than 2 glasses of alcohol per day (\> 20 g of alcohol per day or \> 140 g/week) or men who drink more than 3 glasses of alcohol per day (\> 30 g of alcohol per day or more than 210 g/week);
* Subjects having given their blood within less than 3 months before inclusion;
* Subjects having participated to another clinical trial with an investigational product within less than 1 month before the inclusion.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05427604
Study Brief:
Protocol Section:
NCT05427604