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 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
NCT ID:
NCT05390866
Eligibility Criteria:
Inclusion Criteria:
* Female or male sex,
* Aged between 20 and 29 years old,
* Body Mass Index (BMI) between 18.5 and 24.9 kg/m2,
* Meeting the World Health Organization (WHO) guidelines on physical activity, i.e. at least 150-300 minutes of moderate-intensity aerobic physical activity per week as well as muscle-strengthening activities on 2 or more days per week,
* Clearance for physical activity according to the 2022 Physical Activity Readiness Questionnaire (PAR-Q+),
* Regular menstrual cycle,
* Informed consent as documented by signature.
Exclusion Criteria:
* Females with known pregnancy or breastfeeding,
* Females with known polycystic ovary syndrome (PCOS),
* Current exercise-limiting conditions of the lower limbs (e.g. tendinopathy, fractures or other musculoskeletal pathologies),
* Known acute or chronic diseases: e.g. any active infectious diseases, any past or current malignant tumours, any lung diseases (e.g. bronchial asthma), any cardiometabolic diseases (e.g. arterial hypertension, diabetes, dyslipidaemia), any gastrointestinal diseases (e.g. coeliac disease, Crohn's disease, ulcerative colitis), any psychological disorders (e.g. depression, if medically diagnosed, anorexia, bulimia), any endocrinological diseases (e.g. all types of diabetes mellitus, hyper- or hypothyroidism), any nephrological diseases, any neurological disorders,
* Current or past smoking, current or past psychoactive drug use (alcohol excluded here, see below),
* Excessive alcohol consumption in the past two weeks, defined as either binge drinking (consuming five or more drinks during a single occasion) or heavy drinking (consuming 15 or more drinks per week),
* Any current or regular medication use, including any kind of hormonal contraception,
* Diet: vegetarian, vegan, lactose-free and gluten-free, FODMAP-free (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols),
* Inability to follow the procedures of the study, e.g. due to linguistic or cognitive problems,
* Concomitant involvement in another trial or participation in another trial in the last 4 weeks.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
29 Years
Study:
NCT05390866
Study Brief:
Protocol Section:
NCT05390866