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Role of a Wheat Containing Diet on Non-alcoholic Steatohepatitis (NASH-ATI)

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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

Tracking Information
First Submitted Date  ICMJE August 17, 2019
First Posted Date  ICMJE August 26, 2019
Last Update Posted Date August 26, 2019
Actual Study Start Date  ICMJE October 1, 2018
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2019)
Effect of ATI-free Nutrition on hepatic inflammation [ Time Frame: 16 weeks ]
Reduction of Alanine-Aminotransferase (ALT; U/ml) compared to baseline
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2019)
Quality of Life using the chronic liver disease questionnaire (CLDQ) [ Time Frame: 16 weeks ]
The CLDQ is a validated patient-reported outcome measure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Role of a Wheat Containing Diet on Non-alcoholic Steatohepatitis
Official Title  ICMJE Role of a Wheat-based Diet in NASH (NASH-ATI)
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • NASH - Nonalcoholic Steatohepatitis
  • Diabetes Mellitus, Type 2
  • Hyperlipidemias
Intervention  ICMJE Other: Nutritional Intervention
Dietary Counselling
Study Arms  ICMJE
  • Placebo Comparator: wheat-based diet
    The patients continue a wheat-based diet aiming at a reduction in bodyweight.
    Intervention: Other: Nutritional Intervention
  • Experimental: ATI reduced diet
    Patients are counselled to reduce dietary gluten uptake.
    Intervention: Other: Nutritional Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 22, 2019)
45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jörn M Schattenbrg, MD 00496131176074 joern.schattenberg@unimedizin-mainz.de
Contact: Detlef Schuppan, MD PhD detlef.schuppan@unimedizin-mainz.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04066400
Other Study ID Numbers  ICMJE 2018-13078
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Priv.-Doz. Dr. J. Schattenberg, Johannes Gutenberg University Mainz
Study Sponsor  ICMJE Johannes Gutenberg University Mainz
Collaborators  ICMJE University Hospital, Frankfurt
Investigators  ICMJE Not Provided
PRS Account Johannes Gutenberg University Mainz
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP