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 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT04658134
Eligibility Criteria:
Inclusion Criteria:
1. Age: 21-65 years
2. BMI ≥ 32.5 kg/m2
3. Able to provide informed consent
4. Able to maintain present diet throughout the study duration
Exclusion Criteria:
1. Weight \> 150 kg
2. Type 2 Diabetes Mellitus
3. Allergy to soy
4. Ongoing treatment with weight-loss medications (e.g. orlistat, phentermine, liraglutide)
5. Systemic steroid usage (eg. prednisolone, hydrocortisone, cortisone, dexamethasone)
6. Renal impairment (estimated creatinine clearance estimated by Cockcroft-Gault Equation \< 60 ml/min)
7. Haemoglobin concentration \< 10 g/L
8. Serum alanine aminotransferase or aspartate aminotransferase above 2x upper limit of normal
9. Uncontrolled hypertension (BP \> 180/110 mmHg)
10. Pregnancy
11. Nursing mothers
12. Uncontrolled thyroid disease
13. Surgery requiring general anaesthesia within 4-weeks before enrolment
14. Psychiatric disorders requiring medication
15. Significant alcohol intake (\> 1 unit per day for women and \> 2 units per day for men)
16. Cancer within the last 3-years (except squamous cell and basal cell cancer of the skin)
17. Any factors likely to limit adherence to study protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT04658134
Study Brief:
Protocol Section:
NCT04658134