Actively Recruiting
Mediterranean Diet Versus Western Diet on Fatigue in Autoimmune Hepatitis Patients
Led by Indiana University · Updated on 2026-05-08
48
Participants Needed
1
Research Sites
270 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Mediterranean Diet Versus Western Diet on Fatigue in Autoimmune Hepatitis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Established autoimmune hepatitis confirmed by criteria or liver biopsy
- Stable autoimmune hepatitis with no immunosuppression changes in the last 4 weeks
- Previous participation in the Indiana University GRACE study
- Fatigue score above population mean (PROMIS-29 T-score 65 55)
- Diagnosed with autoimmune hepatitis for more than 6 months
- Age between 18 and 80 years
- Willingness to follow study protocol
- Women of reproductive potential must use effective contraception during the study
- Ability to store frozen food for one week and prepare meals
- Ability to receive weekly frozen food deliveries
- Ability to understand and sign informed consent
You will not qualify if you...
- Diagnosis of celiac disease
- Use of any dedicated dietary intervention
- Diagnosis of variant syndrome involving autoimmune hepatitis and other liver diseases
- Child Pugh score greater than 7
- MELDNa score greater than 7
- Clinical signs of decompensated cirrhosis including ascites, high bilirubin, large esophageal varices, or hepatic encephalopathy
- Pregnant, breastfeeding, or planning pregnancy during the study
- History of liver transplantation
- Current use of investigational drugs
- Allergies or intolerance to foods in the Mediterranean or Western diet
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
IU Health University Hosptial
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
K
Kelsey Green, MPH
CONTACT
R
Regina Weber, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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