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 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT05578703
Eligibility Criteria:
Inclusion Criteria:
1. Subjects aged 21-65
2. Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≤50 kg/m²
3. History of at least one unsuccessful dietary effort to lose body weight
4. Willing and able to participate in the study procedures
5. Understand and voluntarily sign the informed consent
6. Approved ESG candidate at TYWL
7. Access to internet
8. Reliable transportation to and from Cary, North Carolina surrounding area
Exclusion Criteria:
1. Younger than 21 years of age
2. Older than 65 years of age
3. Patients on any medications or supplements including those that may influence cholecystokinin (CCK), glucose, growth hormone, insulin and/or somatostatin levels
4. Milk and/or soy allergies
5. History of any stomach manipulation (including repair of hiatal hernia)
6. History of disordered eating
7. Patients who do not give their consent to the enrollment in the study or are incompetent, unconscious or unable to express their consent for any reason
8. Hemoglobin A1c \> 7.0 or any patient with symptoms suggestive of gastroparesis or a formal diagnosis of gastroparesis
9. Patients taking the following medications known to impair gastric accommodation: buspirone, mirtazapine
10. Patients taking the following medications known to accelerate or impair gastric emptying: Reglan (metoclopramide), Zelnorm (tegaserod), Motegrity (prucalopride), erythromycin, Motilium (domperidone), opiates, anticholinergic agents
11. Patients who are pregnant or who plan to become pregnant during study duration
12. Use of non-steroidal anti-inflammatory medications without the ability to stop these during study duration
13. Patients on chronic anticoagulation
14. History of functional gastrointestinal disorder, including functional dyspepsia, irritable bowel syndrome, or other syndromes known to affect gastric sensorimotor function.
15. Concurrent use of weight loss medications.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT05578703
Study Brief:
Protocol Section:
NCT05578703