NCT04066400

Role of a Wheat Containing Diet on Non-alcoholic Steatohepatitis

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Johannes Gutenberg University Mainz · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Nutritional Intervention	Dietary Counselling

Timeline

• Start date: 2018-10-01
• Primary completion: 2022-01-01
• Completion: 2023-12-27
• First posted: 2019-08-26
• Last updated: 2023-12-28

Locations

2 sites across 1 country: Germany