Diet showdown: mediterranean vs. western for autoimmune fatigue
NCT ID NCT06250309
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares a Mediterranean diet to a Western diet to see which one better reduces fatigue in people with autoimmune hepatitis. About 48 adults will try both diets in a random order. Researchers will measure changes in fatigue and quality of life using a standard questionnaire.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2023
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Established autoimmune hepatitis (AIH) confirmed according to simplified criteria (\>6) or historical confirmatory liver biopsy with inflammation consistent with AIH * Therapeutically stable AIH: no changes to immunosuppression (corticosteroids or baseline immunosuppression) within 4 weeks of study enrollment * Previous enrollment in the Indiana University GRACE study * Fatigue domain score (PROMIS-29) more than population mean (PROMIS 29 score): T-score ≥ 55 * Diagnosis of AIH \> 6 months * Current age: 18 to 80 years old * Willing and agree to comply with protocol requirements * Female patients who are of reproductive potential must agree for the duration of the study to use an effective means of contraception (e.g., abstinence, hormonal contraception methods that inhibit ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal ligation, vasectomized partner) * Capable of storing 1 week duration of frozen food and preparing meals * Capable of receiving weekly frozen food on scheduled day of delivery * Capable of understanding and signing the informed consent document Exclusion Criteria: * Concurrent diagnosis of celiac disease * Concurrent use of dedicated dietary intervention (patient driven or else) * Established diagnosis of variant syndrome (AIH with Primary biliary cholangitis, AIH with Primary sclerosing cholangitis) * Child Pugh score \> 7 * MELDNa score \> 7 * Clinical evidence of de-compensated cirrhosis: ascites, total bilirubin \>1.5, large esophageal varices or history of bleeding, known diagnosis of hepatic encephalopathy * Women who are pregnant or breastfeeding or intend to become so for the entire duration of the study; this information will be self-reported; no pregnancy test will be performed * History of liver transplantation * Current treatment with an investigational drug * Historical intolerance or allergy to foods included in a Mediterranean Diet or a Western Diet
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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IU Health University Hosptial
RECRUITINGIndianapolis, Indiana, 46202, United States
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