Comparing Mediterranean and Western diets for fatigue in autoimmune hepatitis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study investigates the effects of two dietary interventions, the Mediterranean Diet (MD) and the Western Diet (WD), on fatigue and quality of life in patients with autoimmune hepatitis (AIH). It employs a cross-over design where participants will experience both diets in two phases, allowing for direct comparison of their impacts. The study aims to gather data on how dietary changes can alleviate symptoms and improve the overall well-being of individuals suffering from AIH. By focusing on dietary interventions, the study seeks to explore a potentially effective approach to managing this chronic condition.

Why it matters

Who can join: the full rules

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

Where it's running

• IU Health University Hosptial
  Indianapolis, Indiana, United States Recruiting

Study contacts

• Study coordinator: Kelsey Green, MPH
• Email: greenke@iu.edu
• Phone: 317-278-9292

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.