Recruiting

Mediterranean Diet vs. Western Diet

Sponsor:

Indiana University

Code:

NCT06250309

Conditions

Autoimmune Hepatitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Dietary assignment

Study Details

Brief 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

Study ID

NCT06250309

Start date

Oct 23, 2023

Status verified date

May, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Mediterranean Diet (MD)

The Mediterranean Diet (MD) includes similar food patterns to those described in the Healthy Mediterranean-Style Dietary Pattern in the Dietary Guidelines for Americans, 2020-2025. The daily caloric needs of participants will be calculated to ensure weight stability. For a daily 2,000 kcal diet, participants will consume 2.5 cup equivalents of vegetables, 2.5 cup equivalents of fruits, 3 ounce equivalents of whole grains, 2 cup equivalents of dairy, 6 ounces equivalent of protein foods (with 32% from seafood, and 11% from nuts, seeds and soy products), and 27 grams of canola or olive oil, per day. No more than 12% of calories per day will come from discretionary foods (I.e., added sugar, saturated fat).

active comparator: Western Diet (WD)

The Western Diet (WD) includes similar food patterns to those described in the Data Tables of What We Eat in America, NHANES (13) . We will match intake according to gender and age group in years (I.e., 20-29; 30-39; 40-49; 50-59; 60-69; 70 and over). On average, participants will consume 1.6 cup equivalent of vegetables, 0.9 cup equivalents of fruits, 0.8 ounce equivalents of whole grains,1.4 cup equivalents of dairy, 6.3 ounces equivalent of protein foods (with 10% from seafood, and 14% from nuts, seeds and soy products). The diet will contain 12% of calories per day from saturated fat, and 12.7% of calories from added sugars.

Interventions

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.

Primary outcome measure

  • Change in clinical fatigue via Promis 29 [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Kelsey Green, MPH

317-278-9292greenke@iu.edu

Regina Weber, BS

317-278-3584reginaw@iu.edu

Locations

IU Health University Hosptial

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Kelsey Green, MPH

317-278-9292greenke@iu.edu

Regina Weber, BS

317-278-3584reginaw@iu.edu

Principal Investigator:

Craig Lammert, MD

More Information

Sponsor

Indiana University

Last update posted

May 8, 2026

Last verified

May, 2026

Keywords

  • fatigue

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-05-08.