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 @ 2:41 AM
Ignite Modification Date:
2025-12-25 @ 2:41 AM
NCT ID:
NCT05343533
Eligibility Criteria:
Inclusion Criteria:
* between the ages of 18 - 50 years
* has a body mass index between 18.5 - 30 kg/m2.
* Anyone with a body mass index between 30 - 32 kg/m2, but has a body composition \<25% fat -for men and \<35% for women will be accepted into the study
* has been weight stable for the past three months (defined as less than a 5% variation in body -mass over this time)
* is determined to be healthy through completion of a health history questionnaire
Exclusion Criteria:
* Are currently diagnosed or being treated for any cardiac, respiratory, endocrine, psychiatric, musculoskeletal, - renal, hepatic, neuromuscular or metabolic disease or disorder that in the judgement of the study participant's personal physician or research nurse that will preclude their safe participation or will contraindicate quality control over the collected data
* are currently diagnosed with or are being treated for celiac disease, lactose intolerance, digestive insufficiencies or other gastrointestinal complications such as irritable bowel syndrome, ulcerative colitis, etc.
* report having used anabolic steroids within the past 30 days
* report have used any illicit or recreational drugs within the past 30 days
* report the intake of any prescription or over-the-counter medications (i.e., antibiotics) that may impact study outcomes
* report the current use of any dietary supplements known to impact digestion or sleep quality for the past 30 days
* report already taking a probiotic within the past 30 days
* have been actively trying to lose weight
* are currently following a ketogenic or low carbohydrate diet within the past 30 days
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT05343533
Study Brief:
Protocol Section:
NCT05343533