Trials / Active Not Recruiting
Active Not RecruitingNCT04707651
Formula Diet Treatment for NASH Patients.
Formula Diet Treatment for Weight Reduction in NASH Patients.
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- West German Center of Diabetes and Health · Academic / Other
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Formula diet | Formula diet for 12 weeks |
Timeline
- Start date
- 2021-01-18
- Primary completion
- 2024-12-31
- Completion
- 2025-03-31
- First posted
- 2021-01-13
- Last updated
- 2024-07-11
Locations
2 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT04707651. Inclusion in this directory is not an endorsement.