Mediterranean Diet Versus Western Diet on Fatigue in Autoimmune Hepatitis Patients

Launched by INDIANA UNIVERSITY · Feb 1, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how two different diets—the Mediterranean Diet and the Western Diet—affect fatigue levels in patients with autoimmune hepatitis (AIH). The study will involve participants trying both diets over two phases, allowing researchers to see which one helps improve quality of life better. The trial is currently recruiting people aged 18 to 80 who have been diagnosed with AIH and experience higher-than-average fatigue. To join, participants should be stable in their treatment for at least four weeks and be willing to follow the study's dietary guidelines.

Participants in this study will receive weekly deliveries of frozen meals that fit the two diets, and they will be asked to prepare and eat these meals at home. They will also need to keep track of their fatigue levels and share their experiences throughout the trial. It’s important to note that certain health conditions, like celiac disease or severe liver issues, may prevent someone from joining the study. Overall, this trial aims to find out if changing diet can make a real difference in how people with autoimmune hepatitis feel.

Gender

ALL

Eligibility criteria

• 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