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 @ 7:07 PM
Ignite Modification Date:
2025-12-24 @ 7:07 PM
NCT ID:
NCT03915457
Eligibility Criteria:
Inclusion Criteria:
* Healthy male volunteer (see below the description of medical tests and laboratory analysis performed at the selection visit),
* Age 20 to 45,
* No overweight nor excessive thinness with BMI (weight Kg/ height m2) between 20 and 26,
* Height between 158 and 185 cm,
* No personal nor family past record of chronic or acute disease or psychological disturbances which could affect the physiological data and/or create a risk for the subject during the experiment,
* Fitness level assessment:
* if age \< 35 years: 35 ml/min/kg \< VO2max \< 60ml/min/kg
* if age \> 35 years: 30 ml/min/kg \< VO2max \< 60ml/min/kg
* Walking between 7000 - 8000 steps/day,
* Active and free from any orthopedic (in particular no vertebral fracture, scoliosis or herniated disc) musculoskeletal and cardiovascular disorders,
* Non smokers,
* No alcohol, no drug dependence and no medical treatment,
* No antibiotic treatment in the 2 previous months before the beginning of the study,
* Covered by a Social Security system,
* Have signed the information consent,
* Free of any engagement during the study.
Exclusion Criteria:
* \- Past record of orthostatic intolerance,
* Cardiac rhythm disorders,
* Chronic back pains,
* Vertebral fracture, scoliosis or herniated disc,
* Glaucoma,
* HTA,
* History of migraines,
* History of hiatus hernia or gastro-esophageal reflux,
* History of thyroid dysfunction, renal stones, diabetes,
* History of head trauma,
* Past records of thrombophlebitis, family history of thrombosis or positive response in thrombosis screening procedure (anti thrombin III, S-protein, C-protein, factor V Leiden mutation and the mutation 20210 of the prothrombin gene),
* Individuals exhibiting mutations involved in hereditary hemochromatosis (HAMP, HFE, HFE2, SCL40A1 and TRF2),
* Abnormal result for lower limbs echo-doppler,
* History or active claustrophobia,
* History of genetic muscle and bone diseases of any kind,
* Bone mineral density: T-score ≤ -1.5 on the hip,
* Osteosynthesis material, presence of metallic implants or any other contra-indication for MRI,
* Poor tolerance to blood sampling,
* Having given blood (more than 8ml/kg) in a period of 8 weeks or less before the start of the experiment,
* Antibiotic treatment in the 2 previous months before the beginning of the study,
* Vegetarian or vegan,
* History of food allergy,
* Positive reaction to any of the following tests: HVA IgM (hepatitis A), HBs antigen (hepatitis B), anti-HVC antibodies (hepatitis C), anti-HIV1+2 antibodies,
* Subject already participating or in the exclusion period of a clinical research,
* Refusal to give permission to contact his general practitioner,
* Incarcerated persons,
* Subject who, in the judgment of the investigator, is likely to be non-compliant during the study, or unable to cooperate because of a language problem or poor mental development,
* Subject who has received more than 4500 Euros within 12 months for being a research subject.
* Subject under guardianship or trusteeship.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT03915457
Study Brief:
Protocol Section:
NCT03915457