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 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT06503120
Eligibility Criteria:
Inclusion Criteria:
* Willing to change diet for at least three months (accepting reduced sugar, less processed foods, reduced red meat, and following a Mediterranean diet with olive oil, high-fiber foods, vegetables, fruits, nuts, and legumes)
* Intrahepatic triglyceride content (IHTG) of 5%
* Age 18 to 70 years
* Fulfill the diagnosis of Metabolic Dysfunction-Associated Steatotic Liver Disease
* Baseline Mediterranean Diet Adherence Screener (T-MEDAS) score equal to or less than 5
* Participants must not have initiated any new probiotic treatment in the past three months or must have been on a stable probiotic regimen for at least three months, which they are willing to continue for the duration of the study
Exclusion Criteria:
* Other liver disease (viral hepatitis, autoimmune or cholestatic liver disease, Wilson's disease, hemochromatosis, or alpha-1 anti-trypsin deficiency)
* Unstable body weight (variation \>5% within the preceding 3-month period)
* Current use of weight loss medications (e.g., Liraglutide)
* Current use of pioglitazone
* Unstable diabetes (HbA1c \>8.5%)
* Decompensated cirrhosis (international normalized ratio \>1.3, platelets \<100 × 109/mm, bilirubin \>20 mmol/L, albumin \<35 g/L, ascites, or hepatic encephalopathy)
* A serum creatinine level ≥ 2mg/dL
* Presence of active cancer or undergoing chemotherapy either at present or in the prior three years
* Major illness that might require hospitalization
* Pregnancy or lactation for women
* Participation in another trial
* Chronic treatment with warfarin (given its interaction with vitamin K)
* Being implanted with a pacemaker or platinum implant (due to inability to undergo magnetic resonance imaging included in the study design)
* Alcohol consumption above 30 g per week in men or 20 g per week in women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06503120
Study Brief:
Protocol Section:
NCT06503120