Role of a Wheat Containing Diet on Non-alcoholic Steatohepatitis (NASH-ATI)

Johannes Gutenberg University (JGU)

Status: Completed

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

Treatments: Other: Nutritional Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04066400

2018-13078

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

wheat-based diet

Placebo Comparator group

Description:

The patients continue a wheat-based diet aiming at a reduction in bodyweight.

Treatment:

Other: Nutritional Intervention

ATI reduced diet

Experimental group

Description:

Patients are counselled to reduce dietary gluten uptake.

Treatment:

Other: Nutritional Intervention