Role of a Wheat Containing Diet on Non-alcoholic Steatohepatitis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diabetes Mellitus - Type 2
- Hyperlipidemias
- NASH - Nonalcoholic Steatohepatitis
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: prospective, randomized, controlled, bicentric pilot studyMasking: Single (Outcomes Assessor)Masking Description: randomizationPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
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. T...
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.
Tracking Information
- NCT #
- NCT04066400
- Collaborators
- University Hospital, Frankfurt
- Investigators
- Not Provided
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