Role of a Wheat Containing Diet on Non-alcoholic Steatohepatitis

Diabetes Mellitus, Type 2 Clinical Trial

— NASH-ATI  

Official title:

Role of a Wheat-based Diet in NASH (NASH-ATI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04066400
• Other study ID #: 2018-13078
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: December 27, 2023

Study information

• Verified date: December 2023
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 27, 2023
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Fatty Liver
• Hyperlipidemias
• NASH - Nonalcoholic Steatohepatitis
• Non-alcoholic Fatty Liver Disease

Intervention

Other:
• Nutritional Intervention
Dietary Counselling

Locations

Country	Name	City	State
Germany	Universität Frankfurt	Frankfurt
Germany	University Medical Center Mainz	Mainz

Sponsors (2)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz	Goethe University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of ATI-free Nutrition on hepatic inflammation	Reduction of Alanine-Aminotransferase (ALT; U/ml) compared to baseline	16 weeks
Secondary	Quality of Life using the chronic liver disease questionnaire (CLDQ)	The CLDQ is a validated patient-reported outcome measure	16 weeks