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:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT05098093
Eligibility Criteria:
Inclusion Criteria:
* Male adults
* Age between 18 and 35 years (limits included);
* Non-smoking individuals (nor tobacco, nor electronic cigarette nor cannabis, former smokers can be included if they stopped smoking at least 2 years ago);
* Body Mass Index ≥ 19 and \< 30 kg/m2.
* Considered healthy based on their medical history, clinical examination and biological examination;
* Subjects capable of and willing to comply with the protocol and to give their written informed consent.
* Subjects affiliated with a social security scheme.
Non-inclusion Criteria:
Subjects complying with at least one of the following criteria will not be eligible:
* Known metabolic abnormality or clinically significant medical condition, such as:
* Cardiovascular disease (other than hypertension),
* Neurological disease,
* Psychatric disease,
* Immunological disease,
* Endocrine disease (including diabetes or thyroid diseases),
* Chronic kidney disease,
* Heamatological abnormalities
* Hypertension (SBP≥160 mm Hg or DBP ≥100 mm Hg).
* Use of any type of medication or narcotic drug (detected either by the self-declaration of the participant and/ or by the urine TetraHydroCannabinol (THC) test) currently or within the past 2 months before entry into the study;
* Self-reported alcohol intake of \>10 units/ week
* Weight changes above 10% body weight within the past 6 months before entering the study;
* Currently under prescribed diet regimen, whatever the reason;
* Consumption of food supplement(s) currently or within the past 4 weeks before entry into the study, such as but not limited to: botanicals, vitamins, minerals, amino acids; anti-oxydant;
* Any intolerance or allergy documented or suspected to one of the components of the study products;
* Subject presenting a psychological or linguistic inability to sign the informed consent;
* Subject under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision;
* Subject participating in another biomedical study or participation in another study where a product (ie: dietary supplement) were consumed within the 3 months before entry into this study;
* Any regulatory reason according to national applicable regulation;
* Subject having received indemnities for clinical trial reaching at least 4500 Euros considering the last 12 months.
Exclusion criteria :
During the study, in case of emergence of a new health condition or treatment considered as non-inclusion criteria or likely to affect the study parameters according to Investigator's judgment, the participants will be excluded from the study
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT05098093
Study Brief:
Protocol Section:
NCT05098093