RecruitingNot ApplicableNCT06250309

Mediterranean Diet Versus Western Diet on Fatigue in Autoimmune Hepatitis Patients

Randomized Crossover Diet Study Comparing Impact of Mediterranean Diet to Western Diet on Fatigue in Autoimmune Hepatitis Patients

Sponsor

Indiana University

Enrollment

48 participants

Start Date

Oct 23, 2023

Study Type

INTERVENTIONAL

Conditions

Autoimmune Hepatitis

Summary

This is a single-center, proof-of-concept pilot study which uses a cross-over design to compare two dietary interventions/treatments: Western Diet (WD) vs Mediterranean (MD) and impact on quality-of-life parameters in AIH. Participants will receive both treatments through two phases and will be divided into two groups.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria11

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 Criteria10

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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Interventions

DIETARY_SUPPLEMENTDietary assignment

A total of 48 subjects will be randomized by a computer program into one of two groups: MD or WD. Participation in each dietary arm lasts 8 weeks, with a 6 week washout period in between each arm.