Formula Diet Treatment for NASH Patients.

Last updated: July 10, 2024
Sponsor: West German Center of Diabetes and Health
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Liver Disease

Treatment

Formula diet

Clinical Study ID

NCT04707651
NASH
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • BMI>25 kg/qm

Exclusion

Exclusion Criteria:

  • history of drug or alcohol abuse

  • acute or chronic diseases (except type 2 diabetes)

  • pregnancy or breast feeding

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Formula diet
Phase:
Study Start date:
January 18, 2021
Estimated Completion Date:
March 31, 2025

Study 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.

Connect with a study center

  • Düsseldorf Catholic Hospital Group

    Düsseldorf, 40591
    Germany

    Site Not Available

  • Praxis Prof. Erhardt

    Wuppertal, 42283
    Germany

    Site Not Available

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