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Active, Not Recruiting

NCT Number: NCT04707651

Formula Diet Treatment for 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Steatohepatitis, Nonalcoholic Body Weight Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Düsseldorf Catholic Hospital Group, Düsseldorf, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

formula diet

Dietary Supplement

Formula diet for 12 weeks

Primary outcomes

  1. 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

  1. degree of steatosis

    Time frame: 52 weeks

    degree of steatosis in decibels per meter (dB/m) measured by Controlled Attenuation Parameter (CAP) estimation

  2. 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

  3. fat mass

    Time frame: 12 weeks and 52 weeks

    fatt mass in kilogram (kg) measured by Bioelectrical Impedance Analysis (BIA)

  4. Glutamate Pyruvate Transaminase (GPT)

    Time frame: 12 weeks and 52 weeks

    Glutamate Pyruvate Transaminase in units/litre (U/L)

  5. Gamma-glutamyltransferase (GGT)

    Time frame: 12 weeks and 52 weeks

    Gamma-glutamyltransferase in units/litre (U/L)

  6. insulin

    Time frame: 12 weeks and 52 weeks

    insulin in micro units per millilitre (µU/ml)

Sponsors and collaborators

Lead sponsor

West German Center of Diabetes and Health

Other

Registry information

Official study title

Formula Diet Treatment for Weight Reduction in NASH Patients.

Acronym: NASH

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jan 13, 2021
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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