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 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT06101433
Eligibility Criteria:
Inclusion Criteria:
* 18 years or older
* without any history of allergy to soy or excessive consumption of soy products
* without chronic diseases including renal, liver, heart, respiratory, cardiovascular, malignancies, auto immune disorders, cushing's syndrome, thyroid dysfunction, hepatitis, cirrhosis, biliary disorders, diabetes, gastrointestinal tract diseases affecting the gut absorption and psychiatric disorders considering as an obstacle for patients to prepare written informed consent;
* hepatic steatosis grade 2 and higher with fibroscan confirmation (CAP \> 260 dB/m);
* without history of excessive alcohol drink (≥10 g/day);
* without history of drug consumption with approved positive effects on NAFLD treatment (i.e. metformin, vitamin E, ursodeoxycholic acid, phenytoin, tamoxifen, lithium, corticosteroids and methotrexate) in last three months;
* without the history of bariatric surgery or following weight loss diets within 6 months;
* without history of smoking;
* not being a pregnant or lactating woman
Exclusion Criteria:
* consuming less than 90% of intended supplements.
* unwillingness for study collaboration
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06101433
Study Brief:
Protocol Section:
NCT06101433