Role of a Wheat Containing Diet on Non-alcoholic Steatohepatitis (NASH-ATI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04066400|
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : August 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|NASH - Nonalcoholic Steatohepatitis Diabetes Mellitus, Type 2 Hyperlipidemias||Other: Nutritional Intervention||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||prospective, randomized, controlled, bicentric pilot study|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Role of a Wheat-based Diet in NASH (NASH-ATI)|
|Actual Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||September 1, 2020|
|Estimated Study Completion Date :||December 30, 2020|
Placebo Comparator: wheat-based diet
The patients continue a wheat-based diet aiming at a reduction in bodyweight.
Other: Nutritional Intervention
Experimental: ATI reduced diet
Patients are counselled to reduce dietary gluten uptake.
Other: Nutritional Intervention
- Effect of ATI-free Nutrition on hepatic inflammation [ Time Frame: 16 weeks ]Reduction of Alanine-Aminotransferase (ALT; U/ml) compared to baseline
- Quality of Life using the chronic liver disease questionnaire (CLDQ) [ Time Frame: 16 weeks ]The CLDQ is a validated patient-reported outcome measure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066400
|Contact: Jörn M Schattenbrg, MDfirstname.lastname@example.org|
|Contact: Detlef Schuppan, MD PhDemail@example.com|
|Universität Frankfurt||Enrolling by invitation|
|University Medical Center Mainz||Recruiting|
|Contact: Jörn Schattenberg, MD|