Mediterranean Diet Versus Western Diet on Fatigue in Autoimmune Hepatitis Patients
ConditionAutoimmune Hepatitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorIndiana University
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Dietary assignment
Treatment groups
48 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov