Formula Diet Treatment for NASH Patients.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Formula Diet Treatment for Weight Reduction in NASH Patients.

Conditions
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Steatohepatitis, Nonalcoholic

Intervention / Treatment
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* Dietary Supplement: Formula diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Lifestyle intervention including formula diet
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle intervention<br>Nutrition advices and formula diet | Dietary Supplement: Formula diet<br>* Formula diet for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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overweight, fatty liver