Role of a Wheat Containing Diet on Non-alcoholic Steatohepatitis
NASH-ATI
Role of a Wheat-based Diet in NASH (NASH-ATI)
1 other identifier
interventional
40
1 country
2
Brief Summary
Effects of Wheat-based diet vs. ATI-free diet on NASH
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2018
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2018
CompletedFirst Submitted
Initial submission to the registry
August 17, 2019
CompletedFirst Posted
Study publicly available on registry
August 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 27, 2023
CompletedDecember 28, 2023
December 1, 2023
3.3 years
August 17, 2019
December 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of ATI-free Nutrition on hepatic inflammation
Reduction of Alanine-Aminotransferase (ALT; U/ml) compared to baseline
16 weeks
Secondary Outcomes (1)
Quality of Life using the chronic liver disease questionnaire (CLDQ)
16 weeks
Study Arms (2)
wheat-based diet
PLACEBO COMPARATORThe patients continue a wheat-based diet aiming at a reduction in bodyweight.
ATI reduced diet
EXPERIMENTALPatients are counselled to reduce dietary gluten uptake.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johannes Gutenberg University Mainzlead
- Goethe Universitycollaborator
Study Sites (2)
Universität Frankfurt
Frankfurt, Germany
University Medical Center Mainz
Mainz, Germany
Related Publications (1)
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.
PMID: 38462919DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- randomization
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director Metabolic Liver Disease Program
Study Record Dates
First Submitted
August 17, 2019
First Posted
August 26, 2019
Study Start
October 1, 2018
Primary Completion
January 1, 2022
Study Completion
December 27, 2023
Last Updated
December 28, 2023
Record last verified: 2023-12