Randomized Crossover Diet Study Comparing Impact of Mediterranean Diet to Western Diet on Fatigue in Autoimmune Hepatitis Patients
Indiana University
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.
Description
Autoimmune hepatitis (AIH) patients have dramatically reduced quality of life compared to healthy controls. Many symptoms that drive this reduction remain well known, yet clinicians have little to no data on interventions that may reduce symptom burden. As awareness of the broad life impact of autoimmune hepatitis (AIH) has increased, a more comprehensive clinical model that considers other medical interventions such as diet has become more important to patients. Diet has been an area of important study in a number of other auto-inflammatory diseases, particularly focused on pathogenesis, sym…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
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 requ…
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.
Location
- IU Health University HosptialIndianapolis, Indiana