Formula Diet Treatment for Weight Reduction in NASH Patients.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 4
- Primary Endpoint
- degree of steatosis
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •BMI>25 kg/qm
Exclusion Criteria
- •history of drug or alcohol abuse
- •acute or chronic diseases (except type 2 diabetes)
- •pregnancy or breast feeding
Arms & Interventions
Lifestyle intervention
Nutrition advices and formula diet
Intervention: Formula diet (Dietary Supplement)
Outcomes
Primary Outcomes
degree of steatosis
Time Frame: 12 weeks
degree of steatosis in decibels per meter (dB/m) measured by Controlled Attenuation Parameter (CAP) estimation
Secondary Outcomes
- degree of fibrosis(12 weeks and 52 weeks)
- degree of steatosis(52 weeks)
- fat mass(12 weeks and 52 weeks)
- Gamma-glutamyltransferase (GGT)(12 weeks and 52 weeks)
- insulin(12 weeks and 52 weeks)
- Glutamate Pyruvate Transaminase (GPT)(12 weeks and 52 weeks)
Investigators
Stephan Martin
Principal investigator
West German Center of Diabetes and Health