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:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07400367
Eligibility Criteria:
Inclusion Criteria:
* ALT ≥ 60 U/L
* Liver steatosis identified by ultrasound
* Meet at least one cardiometabolic criteria:
1. BMI ≥ 25 kg/m2 (Asian ≥23)
2. Waist circumference: \> 94cm (M) 80cm(F)
3. Fasting blood glucose ≥ 100 mg/dL
4. HbA1c ≥ 5.7
5. Receiving treatment of diabetes
6. Receiving treatment of Hypertension
7. Average home blood pressure: ≥ 130/85 mmHg
8. TG ≥ 150 mg/dL
9. HDL ≤ 40 mg/dL
10. Receiving treatment of dyslipidemia
Exclusion Criteria:
* HBsAg(+)
* Anti-HCV (+)
* Cirrhosis
* Excessive alcohol intake ( Male over 210g/wk; Female over 140mg/wk)
* Could not rule out Autoimmune hepatitis (ANA, or AMA or ASMA (+))
* Could not rule out drug related hepatitis
* Receiving drug that might induce liver steatosis:
* Glucocorticoids
* Amiodarone
* Tamoxifen
* Methotrexate
* Valproate
* Tetracycline
* Chemotherapeutic agents
* Receiving immune modulators or biologics
* Receiving antibiotics within 1 month
* Receiving any cancer treatment
* Have diagnosis of "Catastrophic Illness" defined by Health Administration of Taiwan
* eGFR\<60
* Pregnancy
* Currently enrolled in other dietary or pharmacology clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07400367
Study Brief:
Protocol Section:
NCT07400367