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 @ 9:41 PM
Ignite Modification Date:
2025-12-24 @ 9:41 PM
NCT ID:
NCT04502732
Eligibility Criteria:
Inclusion Criteria:
* Subjects must be 22-65 years of age at time of enrollment
* Subjects must already be consented to 17-007934 or 19-001254
* Subject must be agreeable and compliant with study requirements, including up to three (baseline, 2 month, and 6 month) visits, as well as undergoing GEBT and NSSM testing.
* If female, must be post-menopausal, surgically sterile, or agree to practice a form of birth control or abstinence during year of study and have negative serum HCG at screening/baseline
* Must be willing and able to travel, as needed, to the Investigator's office to complete all routine follow-up visits
Exclusion Criteria:
* Persons presently or soon to be incarcerated
* Females who are pregnant or suspect they may be pregnant
* Persons with nicotine and/or alcohol dependence
* Patients with cognitive impairment that limits their ability to make autonomous decisions
* Known allergies or sensitivities to study materials (eggs and spirulina)
* Assessed, by the physician or delegate, that enrollment would not be appropriate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
65 Years
Study:
NCT04502732
Study Brief:
Protocol Section:
NCT04502732