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 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT06336369
Eligibility Criteria:
Inclusion Criteria:
* written consent, age between 18 and 65 years of age, liver marker (AST, ALT, GGT) \< 2x of the upper norm range, non-smoker, moderate physical activity, ability to understand the requirements of the course of study
Cases: (Gilbert-Syndrom):
* Total bilirubin in the blood \> 1.2 mg/dL (17.1 μM)
* Unconjugated (indirect bilirubin) \> 1 mg/dL
Controls (non-Gilbert-Syndrom):
* Total bilirubin in the blood ≤ 1.2 mg/dL (17.1 μM)
* Unconjugated (indirect bilirubin) ≤ 1 mg/dL
Exclusion Criteria:
* age \< 18 or \> 65 years; having current or any history of cardio-pulmonary, metabolic or musculoskeletal disease; breastfeeding or was/potentially pregnant; liver diseases incl. hep A and B; kidney diseases; active tumor disease; persons with an organ transplant; not willing to meet the demands of the study; not being weight stable (± 5% body mass; self-reported) for at least the 3 months prior to their involvement; or any conditions or concurrent behaviour (including medication) that may have posed undue personal risk to the participant, introduce bias to the study or were influencing liver marker in the last 5 weeks.
Cases: (Gilbert-Syndrom):
* Total bilirubin in the blood ≤ 1.2 mg/dL (17.1 μM)
* Unconjugated (indirect bilirubin) ≤ 1 mg/dL
Controls (non-Gilbert-Syndrom):
* Total bilirubin in the blood \> 1.2 mg/dL (17.1 μM)
* Unconjugated (indirect bilirubin) \> 1 mg/dL
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06336369
Study Brief:
Protocol Section:
NCT06336369