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 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT06800820
Eligibility Criteria:
Inclusion Criteria:
* Liver function tests within reference norms.
* Kidney function tests within reference norms.
* Complete blood count (CBC) within reference norms.
* C-reactive protein (CRP) within reference norms.
* Blood pressure compatible with study requirements.
* Non-smoker or occasional smoker (max 5 cigarettes/day or max 10 ml per week of e-liquid with a nicotine concentration of 3 mg/ml).
* Maximum 5 hours of intense sports per week.
* Weight ≥ 60 kg.
* Body Mass Index (BMI) between 20 and 28 kg/m² (exclusive).
* Subjects who are able and willing to comply with the protocol and give their informed written consent.
* Subjects affiliated with the social security.
Exclusion Criteria:
* Any type of vaccination within the past month.
* Alcohol consumption exceeding WHO standards (Sup. 3 drinks per day for men).
* Ongoing treatment (medication, dietary supplement, or probiotic) and within the four weeks prior to inclusion.
* Known pathology (including seasonal).
* Allergy to the study product
* Individuals following a diet unsuitable for the study (e.g., vegetarian, vegan, or plant-based diets).
* Change in eating habits within the 4 weeks prior to inclusion.
* Medical and/or surgical history deemed incompatible with the trial by the investigator or their representative.
* Persons under guardianship, curatorship, deprived of freedoms, safeguarding justice.
* Refusal to sign the information sheet and consent
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT06800820
Study Brief:
Protocol Section:
NCT06800820