Formula Diet Treatment for NASH Patients.
- Conditions
- Steatohepatitis, Nonalcoholic
- Interventions
- Dietary Supplement: Formula diet
- Registration Number
- NCT04707651
- Lead Sponsor
- West German Center of Diabetes and Health
- Brief Summary
Non-alcoholic steatohepatitis (NASH) - also called fatty liver - is medically a serious problem because the liver tissue becomes fatty and stiff, and inflammatory reactions occur. This increases the risk of liver fibrosis (= scarring of the liver), liver cirrhosis (= shrunken liver), a liver tumor or death. So far there is no recognized treatment option for this disease. However, there is evidence that a lifestyle change based on a reduced carbohydrate diet, more exercise and a significant weight loss that can improve NASH.
- Detailed Description
Outpatients with NASH will be included into this lifestyle intervention study. Patients will get nutritional advices and a formula diet for 12 weeks. Clinical visits will take place at baseline, after 4, 12 and after 52 weeks.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- BMI>25 kg/qm
- history of drug or alcohol abuse
- acute or chronic diseases (except type 2 diabetes)
- pregnancy or breast feeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lifestyle intervention Formula diet Nutrition advices and formula diet
- Primary Outcome Measures
Name Time Method degree of steatosis 12 weeks degree of steatosis in decibels per meter (dB/m) measured by Controlled Attenuation Parameter (CAP) estimation
- Secondary Outcome Measures
Name Time Method degree of fibrosis 12 weeks and 52 weeks degree of fibrosis in meter per second (m/s) measured by Acoustic Radiation Force Impulse (ARFI) elastography
degree of steatosis 52 weeks degree of steatosis in decibels per meter (dB/m) measured by Controlled Attenuation Parameter (CAP) estimation
fat mass 12 weeks and 52 weeks fatt mass in kilogram (kg) measured by Bioelectrical Impedance Analysis (BIA)
Gamma-glutamyltransferase (GGT) 12 weeks and 52 weeks Gamma-glutamyltransferase in units/litre (U/L)
insulin 12 weeks and 52 weeks insulin in micro units per millilitre (µU/ml)
Glutamate Pyruvate Transaminase (GPT) 12 weeks and 52 weeks Glutamate Pyruvate Transaminase in units/litre (U/L)
Trial Locations
- Locations (2)
Praxis Prof. Erhardt
🇩🇪Wuppertal, Germany
Düsseldorf Catholic Hospital Group
🇩🇪Düsseldorf, Germany