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 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT06665958
Eligibility Criteria:
Inclusion Criteria:
* Males
* Aged 18-40 years at recruitment
* BMI ≥ 20 and \< 30kg/m2
* Considered healthy based on their medical history and physical examination.
* Subjects capable of and willing to comply with the protocol and to give their written informed consent.
Exclusion Criteria:
* Existing chronic disease including any; cardiovascular, neurological, gastric/intestinal, hepatic/pancreatic, renal or hematological diseases, obstructive cardiomyopathy, myocardial infarction, intracranial hypertension, diabetes mellitus (type I or II), chronic kidney disease, clinically significant arrhythmia, metabolic anomaly, ischaemia heart disease.
* Uncontrolled Hypertension (\>160/100 mm Hg) or hypotension (\<100/60mm Hg)
* Current use of any medication or narcotics within 2 weeks prior to study entry.
* Currently on a clinically prescribed diet regimen.
* Self-reported alcohol intake of \>10 units/ week
* Have taken antibiotic therapy within the last 3 months
* Following any specific diet (vegetarian, vegan, etc.)
* Consumption of dietary supplement(s) currently or within 4 weeks prior to study entry (i.e. botanicals, vitamins, minerals, amino acids).
* Weight change \> 10% of total body weight within the 6 months before entry to study.
* Any intolerance or allergy documented or suspected to one of the components of the study products.
* Having a psychological or linguistic inability to sign the informed consent; 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 within the 3 months before entry into this study.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT06665958
Study Brief:
Protocol Section:
NCT06665958