Role of a Wheat Containing Diet on Non-alcoholic Steatohepatitis
NCT ID: NCT04066400
Last Updated: 2023-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2018-10-01
2023-12-27
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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wheat-based diet
The patients continue a wheat-based diet aiming at a reduction in bodyweight.
Nutritional Intervention
Dietary Counselling
ATI reduced diet
Patients are counselled to reduce dietary gluten uptake.
Nutritional Intervention
Dietary Counselling
Interventions
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Nutritional Intervention
Dietary Counselling
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Goethe University
OTHER
Johannes Gutenberg University Mainz
OTHER
Responsible Party
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Jörn M. Schattenberg
Director Metabolic Liver Disease Program
Locations
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Universität Frankfurt
Frankfurt, , Germany
University Medical Center Mainz
Mainz, , Germany
Countries
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References
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Armandi A, Bespaljko H, Mang A, Huber Y, Michel M, Labenz C, Galle PR, Neerukonda M, Bugianesi E, Schuppan D, Schattenberg JM. Short-term reduction of dietary gluten improves metabolic-dysfunction associated steatotic liver disease: A randomised, controlled proof-of-concept study. Aliment Pharmacol Ther. 2024 May;59(10):1212-1222. doi: 10.1111/apt.17941. Epub 2024 Mar 11.
Other Identifiers
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2018-13078
Identifier Type: -
Identifier Source: org_study_id