Formula Diet Treatment for NASH Patients. (NASH)

June 2, 2026 updated by: Stephan Martin, West German Center of Diabetes and Health

Formula Diet Treatment for Weight Reduction in NASH Patients.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Düsseldorf, Germany, 40591
        • Düsseldorf Catholic Hospital Group
      • Wuppertal, Germany, 42283
        • Praxis Prof. Erhardt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lifestyle intervention
Nutrition advices and formula diet
Dietary supplement: Formula diet
Formula diet for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
degree of steatosis
Time Frame: 12 weeks
degree of steatosis in decibels per meter (dB/m) measured by Controlled Attenuation Parameter (CAP) estimation
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
degree of steatosis
Time Frame: 52 weeks
degree of steatosis in decibels per meter (dB/m) measured by Controlled Attenuation Parameter (CAP) estimation
52 weeks
degree of fibrosis
Time Frame: 12 weeks and 52 weeks
degree of fibrosis in meter per second (m/s) measured by Acoustic Radiation Force Impulse (ARFI) elastography
12 weeks and 52 weeks
fat mass
Time Frame: 12 weeks and 52 weeks
fatt mass in kilogram (kg) measured by Bioelectrical Impedance Analysis (BIA)
12 weeks and 52 weeks
Glutamate Pyruvate Transaminase (GPT)
Time Frame: 12 weeks and 52 weeks
Glutamate Pyruvate Transaminase in units/litre (U/L)
12 weeks and 52 weeks
Gamma-glutamyltransferase (GGT)
Time Frame: 12 weeks and 52 weeks
Gamma-glutamyltransferase in units/litre (U/L)
12 weeks and 52 weeks
insulin
Time Frame: 12 weeks and 52 weeks
insulin in micro units per millilitre (µU/ml)
12 weeks and 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West German Center of Diabetes and Health

Investigators

  • Principal Investigator: Stephan Martin, MD, West-German Centre of Diabetes and Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2021

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 11, 2021

First Submitted That Met QC Criteria

January 11, 2021

First Posted (Actual)

January 13, 2021

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NASH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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