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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
Sponsor:
Collaborator:
University Hospital, Frankfurt
Information provided by (Responsible Party):
Priv.-Doz. Dr. J. Schattenberg, Johannes Gutenberg University Mainz

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

Condition or disease Intervention/treatment Phase
NASH - Nonalcoholic Steatohepatitis Diabetes Mellitus, Type 2 Hyperlipidemias Other: Nutritional Intervention Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective, randomized, controlled, bicentric pilot study
Masking: Single (Outcomes Assessor)
Masking Description: randomization
Primary Purpose: Treatment
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


Arm Intervention/treatment
Placebo Comparator: wheat-based diet
The patients continue a wheat-based diet aiming at a reduction in bodyweight.
Other: Nutritional Intervention
Dietary Counselling

Experimental: ATI reduced diet
Patients are counselled to reduce dietary gluten uptake.
Other: Nutritional Intervention
Dietary Counselling




Primary Outcome Measures :
  1. Effect of ATI-free Nutrition on hepatic inflammation [ Time Frame: 16 weeks ]
    Reduction of Alanine-Aminotransferase (ALT; U/ml) compared to baseline


Secondary Outcome Measures :
  1. Quality of Life using the chronic liver disease questionnaire (CLDQ) [ Time Frame: 16 weeks ]
    The CLDQ is a validated patient-reported outcome measure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Jörn M Schattenbrg, MD 00496131176074 joern.schattenberg@unimedizin-mainz.de
Contact: Detlef Schuppan, MD PhD detlef.schuppan@unimedizin-mainz.de

Locations
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Germany
Universität Frankfurt Enrolling by invitation
Frankfurt, Germany
University Medical Center Mainz Recruiting
Mainz, Germany
Contact: Jörn Schattenberg, MD         
Sponsors and Collaborators
Johannes Gutenberg University Mainz
University Hospital, Frankfurt
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Responsible Party: Priv.-Doz. Dr. J. Schattenberg, Director Metabolic Liver Disease Program, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT04066400    
Other Study ID Numbers: 2018-13078
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Priv.-Doz. Dr. J. Schattenberg, Johannes Gutenberg University Mainz:
hepatic inflammation
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Diabetes Mellitus, Type 2
Hyperlipidemias
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dyslipidemias
Lipid Metabolism Disorders
Liver Diseases
Digestive System Diseases