Effect of Mediterranean and Western diets on fatigue in patients with autoimmune hepatitis: Protocol for a randomized crossover diet intervention trial.
Craig Lammert, Siri Vuppalanchi, Kelsey Green...
https://pubmed.ncbi.nlm.nih.gov/40368024Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06250309
Randomized Crossover Study Comparing Mediterranean Diet and Western Diet Effects on Fatigue in Autoimmune Hepatitis Patients
Led by Indiana University · Updated on 2026-05-08
48
Participants Needed
1
Research Sites
52 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the effects of two different diets, the Western Diet (WD) and the Mediterranean Diet (MD), on quality of life and fatigue in patients with autoimmune hepatitis (AIH). This pilot study uses a randomized crossover design to compare these dietary treatments and their impact on symptoms, especially fatigue, which is a major concern for AIH patients. The study aims to explore whether diet can help reduce symptom burden in AIH, a condition known to significantly lower patients' quality of life. Participants will be randomly assigned to one of two diet groups: the Mediterranean Diet or the Western Diet. Each participant will follow one diet for 8 weeks, then after a 6-week washout period, switch to the other diet for another 8 weeks. The Mediterranean Diet emphasizes vegetables, fruits, whole grains, dairy, protein foods including seafood, and healthy oils, with limited added sugars and saturated fats. The Western Diet includes lower amounts of fruits and vegetables and higher levels of saturated fat and added sugars, matching typical consumption patterns by age and gender. Both diets will be carefully prepared to maintain participants' weight stability. During the 24-week study, participants will be monitored for changes in fatigue using the PROMIS-29 Fatigue Domain score, as well as overall quality of life, liver stiffness and fat content, and liver-related blood tests including ALT and IgG levels. Assessments will occur at scheduled intervals, and participants will receive weekly frozen food deliveries. The study team and participants will remain unaware of which diet is being provided at each phase to maintain study integrity.
CONDITIONS
Brief Title
Mediterranean Diet Versus Western Diet on Fatigue in Autoimmune Hepatitis Patients
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Established autoimmune hepatitis confirmed by criteria or liver biopsy
- Stable immunosuppressive treatment with no changes within 4 weeks before enrollment
- Previous participation in the Indiana University GRACE study
- Fatigue score above population mean (PROMIS-29 T-score ≥ 55)
- Diagnosis of autoimmune hepatitis for more than 6 months
- Age between 18 and 80 years
- Willingness to follow study protocol
- Female participants of reproductive potential must agree to effective contraception
- Ability to store frozen food for 1 week and prepare meals
- Ability to receive weekly frozen food deliveries
- Ability to understand and sign informed consent
You will not qualify if you...
- Diagnosis of celiac disease
- Use of other dedicated dietary interventions
- Diagnosis of variant syndrome involving AIH and other liver diseases
- Child Pugh score greater than 7
- MELDNa score greater than 7
- Signs of de-compensated cirrhosis such as ascites or large esophageal varices
- Women who are pregnant, breastfeeding, or planning pregnancy during the study
- History of liver transplantation
- Current treatment with an investigational drug
- Allergy or intolerance to foods included in the Mediterranean or Western diets
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Dietary Treatment Period 1
Duration - 8 weeks
Participants follow either the Mediterranean Diet or Western Diet for 8 weeks as their first assigned dietary intervention.
Weekly visits for up to 8 weeks
Washout Period
Duration - 6 weeks
Participants undergo a 6-week washout period between dietary interventions to minimize carryover effects.
1 visit (in-person)
Dietary Treatment Period 2
Duration - 8 weeks
Participants switch to the alternate diet (Mediterranean Diet or Western Diet) for 8 weeks as their second dietary intervention.
Weekly visits for up to 8 weeks
Trial Site Locations
Total: 1 location
1
IU Health University Hosptial
Indianapolis, Indiana, United States, 46202
Actively Recruiting
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Research Team
K
Kelsey Green, MPH
R
Regina Weber, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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