Mediterranean Diet Versus Western Diet on Fatigue in Autoimmune Hepatitis Patients

Description

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

Autoimmune Hepatitis

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Study Overview

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Study Details

Study overview

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.

Randomized Crossover Diet Study Comparing Impact of Mediterranean Diet to Western Diet on Fatigue in Autoimmune Hepatitis Patients

Mediterranean Diet Versus Western Diet on Fatigue in Autoimmune Hepatitis Patients

Condition
Autoimmune Hepatitis
Intervention / Treatment

-

Contacts and Locations

Indianapolis

IU Health University Hosptial, Indianapolis, Indiana, United States, 46202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Indiana University,

Study Record Dates

2028-12-31