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 @ 4:53 AM
Ignite Modification Date:
2025-12-25 @ 4:53 AM
NCT ID:
NCT04417218
Eligibility Criteria:
Inclusion Criteria:
* Prior participant in 2-AAA screening study.
* Identified as eligible due to high or low plasma 2-AAA, in the absence of hyperglycemia, as defined by study team.
Exclusion Criteria:
* Individuals who currently use tobacco products.
* Use of prescription or over-the-counter medications or dietary supplements which could modulate levels of 2-AAA and unwilling to discontinue use (from 24 hours prior to first study visit until completion of study). Hormonal birth control is acceptable.
* Follow a severely restricted diet or have food allergies, which would preclude adherence to study diet.
* Newly diagnosed disease (since screening visit), including cardiovascular, renal, or liver disease, or Diabetes mellitus.
* Individuals who are pregnant or lactating
* Inability to provide written or electronic informed consent
* Inability to fast for 8 hours
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT04417218
Study Brief:
Protocol Section:
NCT04417218