Mediterranean Diet Versus Western Diet on Fatigue in Autoimmune Hepatitis Patients

NCT06250309 | Recruiting

• 1 other identifier: 20127
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Keywords

fatigue

Outcome Measures

Primary Outcomes (1)

• Change in clinical fatigue via Promis 29

  Assessment from the patient only through data collection from the Promis-29 instrument. This 29 item instrument that measures various difficulties in health related quality of life in 7 domains. For this measure, a higher scores equals more of the concept being measured.

  24 weeks

Secondary Outcomes (4)

• Change in overall health related quality of life via Promis 29

  24 weeks

• Changes in liver stiffness and fat content via transient elastography

  24 weeks

• Change in alanine transaminase (ALT) value

  24 weeks

• Change in IgG value

  24 weeks

Study Arms (2)

Mediterranean Diet (MD)

ACTIVE COMPARATOR

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).

Dietary Supplement: Dietary assignment

Western Diet (WD)

ACTIVE COMPARATOR

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.

Dietary Supplement: Dietary assignment

Interventions

Dietary assignment DIETARY_SUPPLEMENT

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.

Mediterranean Diet (MD); Western Diet (WD)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

IU Health University Hosptial

Indianapolis, Indiana, 46202, United States

RECRUITING

Related Publications (1)

• Lammert C, Vuppalanchi S, Green K, Blessing N, Desai AP, Stump T, Miller NG, Spence L, Wright A. Effect of Mediterranean and Western diets on fatigue in patients with autoimmune hepatitis: Protocol for a randomized crossover diet intervention trial. Contemp Clin Trials. 2025 Jul;154:107951. doi: 10.1016/j.cct.2025.107951. Epub 2025 May 12.

  PMID: 40368024 DERIVED

MeSH Terms

Conditions

Hepatitis, Autoimmune; Fatigue

Condition Hierarchy (Ancestors)

Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kelsey Green, MPH

CONTACT

317-278-9292; greenke@iu.edu

Regina Weber, BS

CONTACT

317-278-3584; reginaw@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Study investigators will be blinded as to the randomization for all participants until all study procedures are completed.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: A total of 48 participants will be enrolled in this trial with two phases: Western Diet and Mediterranean Diet. Each participant will complete both phases, with a 6 week wash out period in between the phases. Each participant is randomized, in a 1:1 ratio, to one particular diet. When the first phase is completed, the wash out period begins. After completion of the wash out phase, the participant is crossed over into the other diet.

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: October 23, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)