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 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT06986356
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 and ≤ 45 years
* Body Mass Index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2
* Written informed consent
* Willingness and ability to comply with the protocol in the opinion of the Investigator
* Judged by the Investigator to be in good health as assessed by a health screening questionnaire
* Currently identifies as the same biological sex as at birth
Exclusion Criteria:
* Any known ongoing medical condition that interferes significantly with absorption and digestion and/or gastrointestinal (GI) function (e.g. inflammatory bowel disease, gastroesophageal reflux disease, celiac disease, diaphragmatic hernia or diaphragmatic surgery, gastric ulcer, gastritis, gall bladder problems, pancreatitis, GI cancer, oesophageal and/or gastric surgery), in opinion of the investigator.
* Known musculoskeletal or soft tissue injury
* Known cardiovascular disease, disease related to the immune system and/or the respiratory system
* Known renal or hepatic failure or known thyroid dysfunction
* Known Diabetes Mellitus type I or type II, insulin resistance or metabolic syndrome
* Any ongoing cancer (except for basal cell carcinoma) and/ or cancer treatment
* Known anaemia or low haemoglobin or low iron status
* Any known bleeding disorder or reaction to withdrawal of blood samples
* Use of oral and systemic use of prokinetics, laxatives, antidiarrheals, anticoagulants within 2 weeks prior to screening
* Use of systemic antibiotics within 4 weeks prior to screening
* Any known allergies or intolerances to ingredients of the study product, i.e. cow's milk allergies, lactose intolerance
* Adherence to a strict dietary regime (e.g. vegetarian/ vegan/ paleo/ketogenic/intermittent fasting/ high protein diet (\>1.6 g/kg body weight/day) or a weight loss program)
* Use of any nutritional supplements or additional protein supplements or nutritional support within 4 weeks prior to screening
* Falling below or exceeding the classification of Tier 1 or Tier 2 (McKay et al 2022, IJSPP. 17, 317-331). Ranging from minimum of meeting WHO guidelines for physical activity up to training \~3 times per week and local level representation in a sport.
* Known pregnancy and/or lactation
* Current smoking or stopped smoking for \<1 month prior to screening (except for incidental smoking of ≤3 cigarettes/cigars/pipes per week on average in the last month)
* Average alcohol use of \>21 glasses\* per week for men or \>14 glasses per week for women (on average during the last 6 months) or drug/ medicine abuse in opinion of the investigator
* Participation in any other clinical study with investigational or marketed products concomitantly or within 4 weeks before screening.
* Major medical or surgical event requiring hospitalization within the preceding 3 months and/or scheduled in the period of study participation relevant in the opinion of the Investigator
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT06986356
Study Brief:
Protocol Section:
NCT06986356