Role of a Wheat Containing Diet on Non-alcoholic Steatohepatitis (NASH-ATI)
Primary Purpose
NASH - Nonalcoholic Steatohepatitis, Diabetes Mellitus, Type 2, Hyperlipidemias
Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Nutritional Intervention
Sponsored by
About this trial
This is an interventional treatment trial for NASH - Nonalcoholic Steatohepatitis focused on measuring hepatic inflammation
Eligibility 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
Sites / Locations
- Universität Frankfurt
- University Medical Center Mainz
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
wheat-based diet
ATI reduced diet
Arm Description
The patients continue a wheat-based diet aiming at a reduction in bodyweight.
Patients are counselled to reduce dietary gluten uptake.
Outcomes
Primary Outcome Measures
Effect of ATI-free Nutrition on hepatic inflammation
Reduction of Alanine-Aminotransferase (ALT; U/ml) compared to baseline
Secondary Outcome Measures
Quality of Life using the chronic liver disease questionnaire (CLDQ)
The CLDQ is a validated patient-reported outcome measure
Full Information
NCT ID
NCT04066400
First Posted
August 17, 2019
Last Updated
March 28, 2022
Sponsor
Johannes Gutenberg University Mainz
Collaborators
Goethe University
1. Study Identification
Unique Protocol Identification Number
NCT04066400
Brief Title
Role of a Wheat Containing Diet on Non-alcoholic Steatohepatitis
Acronym
NASH-ATI
Official Title
Role of a Wheat-based Diet in NASH (NASH-ATI)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johannes Gutenberg University Mainz
Collaborators
Goethe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NASH - Nonalcoholic Steatohepatitis, Diabetes Mellitus, Type 2, Hyperlipidemias
Keywords
hepatic inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective, randomized, controlled, bicentric pilot study
Masking
Outcomes Assessor
Masking Description
randomization
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
wheat-based diet
Arm Type
Placebo Comparator
Arm Description
The patients continue a wheat-based diet aiming at a reduction in bodyweight.
Arm Title
ATI reduced diet
Arm Type
Experimental
Arm Description
Patients are counselled to reduce dietary gluten uptake.
Intervention Type
Other
Intervention Name(s)
Nutritional Intervention
Intervention Description
Dietary Counselling
Primary Outcome Measure Information:
Title
Effect of ATI-free Nutrition on hepatic inflammation
Description
Reduction of Alanine-Aminotransferase (ALT; U/ml) compared to baseline
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Quality of Life using the chronic liver disease questionnaire (CLDQ)
Description
The CLDQ is a validated patient-reported outcome measure
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Universität Frankfurt
City
Frankfurt
Country
Germany
Facility Name
University Medical Center Mainz
City
Mainz
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Role of a Wheat Containing Diet on Non-alcoholic Steatohepatitis
We'll reach out to this number within 24 hrs