NASH - Nonalcoholic SteatohepatitisNASH-ATINCT04066400
Role of a Wheat Containing Diet on Non-alcoholic Steatohepatitis
A study testing Nutritional Intervention in people with NASH - Nonalcoholic Steatohepatitis and Diabetes Mellitus, Type 2, run by Johannes Gutenberg University Mainz at 2 sites in Germany.
Trial summary
Effects of Wheat-based diet vs. ATI-free diet on NASH Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NASH - Nonalcoholic Steatohepatitis, Diabetes Mellitus, Type 2, Hyperlipidemias
- What is being tested?
- Nutritional Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Oct 2018to 27 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- drugs causing secondary NASH (e.g. Tamoxifen, corticosteroids)
- immunological or inflammatory diseases (e.g. systemic Lupus erythematodes)
- warfarin therapy
- implementation of another Special diet
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Universität Frankfurt
Frankfurt
University Medical Center Mainz
Mainz
About this study
Official title: Role of a Wheat-based Diet in NASH (NASH-ATI)
Effects of Wheat-based diet vs. ATI-free diet on NASH
Read the 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.
- Being tested
- Nutritional Intervention
- Keywords
- hepatic inflammation
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 2, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional InterventionOther
Dietary Counselling
| Study group | Role | What they receive |
|---|---|---|
| wheat-based diet | Placebo comparator | The patients continue a wheat-based diet aiming at a reduction in bodyweight. Receives: Other: Nutritional Intervention |
| ATI reduced diet | Experimental | Patients are counselled to reduce dietary gluten uptake. Receives: Other: Nutritional Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of ATI-free Nutrition on hepatic inflammation
Reduction of Alanine-Aminotransferase (ALT; U/ml) compared to baseline
Measured: 16 weeks
Secondary outcomes (1)
Quality of Life using the chronic liver disease questionnaire (CLDQ)
The CLDQ is a validated patient-reported outcome measure
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start1 Oct 2018
- Primary completion1 Jan 2022
- Study completion27 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NASH - Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized, controlled, bicentric pilot study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Collaborators
- Goethe University
- Responsible party
- Principal investigator, Jörn M. Schattenberg, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04066400
- Sponsor's protocol ID
- 2018-13078
- Other IDs
- 2018
- Acronym
- NASH-ATI
- Status last verified
- Dec 2023
- First submitted
- 17 Aug 2019
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38462919
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of a Wheat-based Diet in NASH (NASH-ATI)
- ClinicalTrials.gov ID
- NCT04066400
- Acronym / sponsor ID
- NASH-ATI / 2018-13078
- Keywords
- hepatic inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Collaborators
- Goethe University
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 27 Dec 2023 (actual)
- First posted
- 26 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, randomized, controlled, bicentric pilot study
| Arm | Type | Receives |
|---|---|---|
| wheat-based diet | Placebo comparator | Other: Nutritional InterventionThe patients continue a wheat-based diet aiming at a reduction in bodyweight. |
| ATI reduced diet | Experimental | Other: Nutritional InterventionPatients are counselled to reduce dietary gluten uptake. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional InterventionDietary Counselling | Other | ATI reduced diet, wheat-based diet |
Primary outcome
Effect of ATI-free Nutrition on hepatic inflammation
Time frame: 16 weeks
Reduction of Alanine-Aminotransferase (ALT; U/ml) compared to baseline
1 secondary outcome
Quality of Life using the chronic liver disease questionnaire (CLDQ)
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
- Derived from this study: PubMed 38462919Armandi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Intervention in people with NASH - Nonalcoholic Steatohepatitis and Diabetes Mellitus, Type 2, run by Johannes Gutenberg University Mainz at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of ATI-free Nutrition on hepatic inflammation (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04066400, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2023.