Comparing Mediterranean and Western diets for fatigue in autoimmune hepatitis patients
Randomized Crossover Diet Study Comparing Impact of Mediterranean Diet to Western Diet on Fatigue in Autoimmune Hepatitis Patients
This study is testing whether following a Mediterranean diet or a Western diet can help reduce fatigue and improve quality of life for people with autoimmune hepatitis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT06250309 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effects of two dietary interventions, the Mediterranean Diet (MD) and the Western Diet (WD), on fatigue and quality of life in patients with autoimmune hepatitis (AIH). It employs a cross-over design where participants will experience both diets in two phases, allowing for direct comparison of their impacts. The study aims to gather data on how dietary changes can alleviate symptoms and improve the overall well-being of individuals suffering from AIH. By focusing on dietary interventions, the study seeks to explore a potentially effective approach to managing this chronic condition.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 with a confirmed diagnosis of autoimmune hepatitis and significant fatigue.
Not a fit: Patients with stable autoimmune hepatitis who do not experience fatigue or those with contraindications to dietary changes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide dietary recommendations that significantly improve the quality of life for patients with autoimmune hepatitis.
How similar studies have performed: Previous studies have shown promising results for dietary interventions in other autoimmune conditions, suggesting potential success for this approach in autoimmune hepatitis.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Indianapolis, Indiana
- IU Health University Hosptial — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Study coordinator: Kelsey Green, MPH
- Email: greenke@iu.edu
- Phone: 317-278-9292
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.