MedTrace Logo

Mediterranean Diet Versus Western Diet on Fatigue in Autoimmune Hepatitis Patients

NCT06250309 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

  • Autoimmune Hepatitis

Interventions

DIETARY_SUPPLEMENT

Dietary assignment

A total of 48 subjects will be randomized by a computer program into one of two groups: MD or WD. Participation in each dietary arm lasts 8 weeks, with a 6 week washout period in between each arm.

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-23
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06250309 on ClinicalTrials.gov