NCT04066400Completed
Role of a Wheat Containing Diet on Non-alcoholic Steatohepatitis
Role of a Wheat-based Diet in NASH (NASH-ATI)
Source: ClinicalTrials.gov · Last updated 28 Dec 2023
Brief summary (registry, in English)
Effects of Wheat-based diet vs. ATI-free diet on NASH
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 17 Aug 2019
- Start date
- 1 Oct 2018
- Primary completion date
- 1 Jan 2022
- Lead sponsor
- Johannes Gutenberg University Mainz
- NCT number
- NCT04066400
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 1 Oct 2018 to the primary completion date, 1 Jan 2022
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- drugs causing secondary NASH (e.g. Tamoxifen, corticosteroids)
- warfarin therapy
Other illness
- unstable coronary heart disease, stroke in the past 6 months
- different liver diseases
- immunological or inflammatory diseases (e.g. systemic Lupus erythematodes)
Other
- 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
- implementation of another Special diet
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universität Frankfurt Coordinator of this site? Confirm its status | Frankfurt | Germany | Unknown status |
| University Medical Center Mainz Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.