Diabetes Mellitus, Type 2, Hyperlipidemias, NASH - Nonalcoholic Steatohepatitis
Conditions
Keywords
hepatic inflammation
Brief summary
Effects of Wheat-based diet vs. ATI-free diet on NASH
Detailed description
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.
Interventions
OTHERNutritional Intervention
Dietary Counselling
Sponsors
Goethe University
Johannes Gutenberg University Mainz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
randomization
Intervention model description
prospective, randomized, controlled, bicentric pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of ATI-free Nutrition on hepatic inflammation | 16 weeks | Reduction of Alanine-Aminotransferase (ALT; U/ml) compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life using the chronic liver disease questionnaire (CLDQ) | 16 weeks | The CLDQ is a validated patient-reported outcome measure |
Countries
Germany
Outcome results
None listed