Role of a Wheat Containing Diet on Non-alcoholic Steatohepatitis

Johannes Gutenberg University Mainz40 enrolled

Overview

Effects of Wheat-based diet vs. ATI-free diet on NASH

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

NASH - Nonalcoholic Steatohepatitis Diabetes Mellitus, Type 2 Hyperlipidemias

Interventions

Nutritional InterventionOTHER

Dietary Counselling

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (2)

Universität Frankfurt

Frankfurt, Germany

University Medical Center Mainz

Mainz, Germany

Outcomes

Primary Outcomes

Effect of ATI-free Nutrition on hepatic inflammation

Reduction of Alanine-Aminotransferase (ALT; U/ml) compared to baseline

Time frame: 16 weeks

Secondary Outcomes

Quality of Life using the chronic liver disease questionnaire (CLDQ)

The CLDQ is a validated patient-reported outcome measure

Time frame: 16 weeks

Data from ClinicalTrials.gov

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