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 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT03610958
Eligibility Criteria:
Inclusion Criteria:
1. 21 ≤ Age \<65 years
2. 28 \< BMI ≤ 40 kg/m2
3. Healthy subject
4. Normal blood count and chemistry
5. Subject is able and willing to give informed consent
6. Subject is able and willing to participate in the study and follow protocol procedures
Exclusion Criteria:
A. General health and medication
1. Any history or evidence of significant cardiac, renal, neurologic, pulmonary, gastrointestinal, hematologic abnormality, chronic hepatic disease or any other disease or symptom which in the judgment of the investigator would interfere with the study or confound the results
2. Symptomatic or unbalanced metabolic syndrome, or, symptomatic or unbalanced type 2 diabetes - such patients with minor symptoms may be allowed according to the PI discretion
3. Intake of chronic medication which may affect the GI or interrupt with the treatment, unless approved by the PI discretion
4. Taking thyroid hormone deficiency drugs (such as L-thyroxine)
5. Hemoglobin level under 11 gm/dl
B. Weight loss history and status
6. Currently using pharmaceutical agents or food supplements for weight loss
7. History of weight reduction of more than 5% of total body weight in the past 6 months
8. Eating disorder such as anorexia, bulimia compulsory overeating or emotional eating\*
C. Specific GI history and status
9. History or evidence of any active liver disease. (abnormal liver functions: \>1.5 times upper limit)
10. Subject with Inflammatory Bowel Disease (IBD)
11. Significant swallowing disorders
12. Less than 3 natural bowel movements per week
13. Past history of any gastrointestinal surgery (excluding uncomplicated appendectomy)
14. Malabsorption disorders
D. General
15. History of food allergy according to PI decision
16. Female subjects who are breastfeeding or have a positive pregnancy test at screening or at any time during the study
17. History of alcohol or drug abuse within 6 months of screening
18. Mental disorders
19. Currently participating in an ongoing clinical study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT03610958
Study Brief:
Protocol Section:
NCT03610958