RECRUITING

Mediterranean Diet Versus Western Diet on Fatigue in Autoimmune Hepatitis Patients

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-10-23

Study Completion:2028-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06250309

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.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Kelsey Green, MPH

CONTACT

317-278-9292

greenke@iu.edu

Regina Weber, BS

CONTACT

317-278-3584

reginaw@iu.edu

Study Locations (Sites)

IU Health University Hosptial

Indianapolis, Indiana, 46202

United States

Collaborators and Investigators

Sponsor: Indiana University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-23

Study Completion Date2028-12-31

Study Record Updates

Study Start Date2023-10-23

Study Completion Date2028-12-31

Terms related to this study

Keywords Provided by Researchers

fatigue

Additional Relevant MeSH Terms

Autoimmune Hepatitis