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Dietary Interventions for Fatigue in Autoimmune Hepatitis

This study is looking at how different diets affect fatigue in people with autoimmune hepatitis (AIH). AIH is a condition where your body's immune system attacks your liver. The study compares two diets: the Mediterranean Diet (MD) and the Western Diet (WD). Researchers want to see if one diet helps reduce fatigue more than the other. You can join if you are 18 to 80 years old, have confirmed AIH, and your medication for AIH has been stable for at least four weeks. The main goal is to measure changes in fatigue using a tool called Promis 29 after 24 weeks. The current recruitment status is unclear.

Study design
This is a single-center pilot study with 48 participants. It uses a crossover design, meaning you will try both the Mediterranean Diet and the Western Diet at different times.
What's involved
You will be assigned to one diet for 8 weeks, followed by a 6-week break, and then the other diet for 8 weeks. The study measures fatigue at 24 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for measuring fatigue is at 24 weeks.

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NCT06250309

Mediterranean Diet Versus Western Diet on Fatigue in Autoimmune Hepatitis Patients

Recruiting
NAAges 18–80InterventionalSupportive care
Indiana University
~48 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:Dietary assignment

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in clinical fatigue via Promis 29
Measured over 24 weeks

Conditions

Autoimmune Hepatitis

Explore related trials

Autoimmune Hepatitis

Where it's being run

1 sites across 1 states
Indiana1

Who to contact

Kelsey Green, MPH
[email protected]
317-278-9292
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in clinical fatigue via Promis 2924 weeks

    Assessment from the patient only through data collection from the Promis-29 instrument. This 29 item instrument that measures various difficulties in health related quality of life in 7 domains. For this measure, a higher scores equals more of the concept being measured.