Mediterranean Diet Versus Western Diet on Fatigue in Autoimmune Hepatitis Patients (NCT06250309) | Clinical Trial Compass
RecruitingNot Applicable
Mediterranean Diet Versus Western Diet on Fatigue in Autoimmune Hepatitis Patients
United States48 participantsStarted 2023-10-23
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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: ascit…