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 @ 12:37 PM
Ignite Modification Date:
2025-12-24 @ 12:37 PM
NCT ID:
NCT04664361
Eligibility Criteria:
Inclusion Criteria:
* Body Mass Index ranging from 20 to 28 kg/m2(bounds included);
* Body weight between of 70 kg to 100 kg (including limits);
* Able to provide written informed consent to participate;
* Having a moderate level of physical activity according to the Global Physical Activity Questionnaire (GPAQ);
* Having a sport practice involving endurance or split races (including collective or individual sports) or cycling.
* Agreeing not to change their physical activity habits throughout the study;
Exclusion Criteria:
* Having a mental state that does not allow them to give free and informed consent to participate in the study;
* Being taking regularly or have taken within the last month any medication or dietary supplement that may increase endurance, recovery, or physical capacity. In particular, the following drugs are strictly prohibited: beta-2 agonists such as salbutamol (Ventolin®), terbutaline (Bricanyl®), fenoterol (Berotec®), salmeterol (Serevent®) and formoterol (Foradil®) as well as corticosteroids;
* Having history of a recent (less than 3 months) lower extremity muscle injury;
* Presenting a depressive syndrome;
* Presenting, in the opinion of the investigator, any symptomatology, pathology or cardiovascular risk factors that are incompatible with the conduct of the study or with the performance of a stress test or that could influence the results of the study, and in particular: 1) an abnormal resting and/or stress ECG at the inclusion visit according to the investigator; 2) presence of abnormalities in the lipid balance (Total Cholesterol, Triglycerides, HDL, LDL), blood glucose, and/or hemodynamic parameters;
* Presenting an abnormal biological balance (Creatinine, Uric acid, Troponin, Alanine aminotransferase / Aspartate aminotransferase, Lactate dehydrogenase, Creatine Kinase, C-reactive protein, Transferrin, Bilirubin, Gamma Glutamyl transpeptidase, Cholesterol (EAL), Glycemia, Ionogram, Alkaline phosphatase );
* Being not be compliant with the constraints imposed by the protocol;
* Having an allergy or a contraindication to the components of the studied products;
* Being already involved in another clinical trial or being in the exclusion period of a previous clinical trial;
* Being unable to understand, speak and read French fluently;
* Being not affiliated with a health insurance company;
* Being vulnerable persons or persons deprived of liberty by a judicial or administrative decision;
* Consuming illegal psychotropic substances or having an alcohol consumption of more than 2 glasses of alcohol/wine per day.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
49 Years
Study:
NCT04664361
Study Brief:
Protocol Section:
NCT04664361