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 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT03897218
Eligibility Criteria:
Inclusion Criteria:
* Fatty liver disease diagnosed by sonography (steatosis hepatis grade II and III) and CAP measurement (\> 280dB)
* compliance
Exclusion Criteria:
* Allergy to oats
* Alcohol intake of more than 30 g/d (men) or 20 g/d (women)
* Treatment with ursodeoxycholic acid (UDCA), vitamin E or other NASH drugs 3 months prior to randomization
* Hepatocellular carcinoma or non-hepatic malignancy within the last 5 years
* Evidence of cirrhosis of the liver (Child A, B, C) or a history of decompensation
* Liver diseases not related to NASH, including chronic viral hepatitis B/D or C, autoimmune hepatitis, Wilson's disease or clinically manifest iron overload (heterozygous HFE is permitted), cholestatic liver disease (PBC/PSC)
* Adiposity surgery in the last 5 years
* BMI \<18.5 kg / m2
* Liver transplantation
* Fibroscan\> 12 kPa (patients with liver cirrhosis)
* Lack of CAP and ultrasound evaluation
* Age \> 75 years
* HIV infection
* Heart Failure (New York Heart Association Class III - IV)
* Myocardial infarction, unstable coronary artery disease, coronary artery intervention or stroke in the last 6 months
* Unstable COPD, chronic inflammatory bowel disease or rheumatoid arthritis
* Unstable renal failure (changes in serum creatinine \> 50% in the last 3 months) or terminal renal failure requiring dialysis
* Uncontrolled hypertension (SBP / DBP\> 180/90 despite therapy)
* Uncontrolled metabolic conditions (poorly controlled or decompensated diabetes mellitus, HbA1c \>7.5%)
* Food allergies or intolerances that require strict adherence to a diet, such as lactose intolerance or celiac disease.
* Pregnancy or breastfeeding women (anamnesis)
* Treatment with drugs or substances that can induce secondary NASH (e.g., tamoxifen, corticosteroids, amiodarone, methotrexate) or alleviate NASH (TNF antagonists) (e.g. metformin)
* Use of herbal food supplements
* Any participant who has taken antibiotics 6 weeks prior to the study
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
75 Years
Study:
NCT03897218
Study Brief:
Protocol Section:
NCT03897218