Role of a Wheat Containing Diet on Non-alcoholic Steatohepatitis

Study Overview
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Brief Summary
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Effects of Wheat-based diet vs. ATI-free diet on NASH

Detailed Description
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40 patients with the diagnosis of a non-alcoholic- steatohepatitis (NASH) will be recruited at the University Hospitals of Mainz and Frankfurt. Patients are assessed with regards to their diet using standardized questionnaire and nutritionists. Patients will be randomized into two parallel groups. The first group will continue a wheat-based Nutrition, while the second Group will receive dietary counselling to achieve an ATI-free nutrition, trying to reduce the daily ATI consumption. The clinical trial will run over 16 weeks including 4 visits at the study center. Study visits include physical examinations, blood-based parameters, cytokines and urine samples, as well for the analysis of the intestinal microbiome by using stool samples. In addition the patients have to complete dietary and health-related quality of life (HRQL) questionnaires. Visits are planned at baseline, W4, W8 and W16.

Official Title
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Role of a Wheat-based Diet in NASH (NASH-ATI)

Conditions
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NASH - Nonalcoholic Steatohepatitis, Diabetes Mellitus, Type 2, Hyperlipidemias

Intervention / Treatment
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* Other: Nutritional Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically proven NASH in the past 36 months with increased ALT: males: >60, females: >42 U/ml no body weight modification about >10% in the past 24 weeks no new drugs treating parts of the metabolic syndrome in the past 12 weeks for patients with Diabetes: HbA1c value <8,6% the ability to understand the aim and the possible individual consequences of this Trial signed and dated consent before the Trial starts Exclusion Criteria: unstable coronary heart disease, stroke in the past 6 months different liver diseases proceeded fibrosis (Fibroscan >9,6 kPA) or histological cirrhosis hepatocellular carcinoma or not curative treated carcinomas alcohol consumption >10g/day (females), >20g/day (males) gravidity drugs causing secondary NASH (e.g. Tamoxifen, corticosteroids) immunological or inflammatory diseases (e.g. systemic Lupus erythematodes) warfarin therapy implementation of another Special diet

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, randomized, controlled, bicentric pilot study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: wheat-based diet<br>The patients continue a wheat-based diet aiming at a reduction in bodyweight. | Other: Nutritional Intervention<br>* Dietary Counselling<br>|
| Experimental: ATI reduced diet<br>Patients are counselled to reduce dietary gluten uptake. | Other: Nutritional Intervention<br>* Dietary Counselling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of ATI-free Nutrition on hepatic inflammation | Reduction of Alanine-Aminotransferase (ALT; U/ml) compared to baseline | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life using the chronic liver disease questionnaire (CLDQ) | The CLDQ is a validated patient-reported outcome measure | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatic inflammation