Randomized Crossover Diet Study Comparing Impact of Mediterranean Diet to Western Diet on Fatigue in Autoimmune Hepatitis Patients
C
Craig Lammert, MD
Primary Investigator
Overview
What is this study about?
One of the most common symptoms reported by people with autoimmune hepatitis (AIH) is fatigue (tiredness and lack of energy). The impact of fatigue on quality of life is substantial and the role that diet plays in the amount of fatigue is unknown. The purpose of this study is to test how consumption of two different diets, the Mediterranean Diet (MD) and the Western Diet (WD), affect fatigue levels and overall quality of life in people who have AIH.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Participants will be from among those already enrolled in the GRACE study (IRB 1403861741) and they will be recruited at their clinic visits.
Description
What happens during study participation?
- Participants will receive both treatments - Western Diet (WD) vs Mediterranean (MD) - through two phases and will be divided into two groups.
- Meals will be assigned to each diet intervention and will be provided to participants.
- Study participation lasts 22 weeks.
Additional Information
The study is being conducted by Dr. Craig Lammert who is a hepatologist (liver doctor) with the Department of Gastroenterology/Hepatology at the Indiana University School of Medicine.
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
autoimmune hepatitis, AIH
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Age: Between 18 Years - 80 Years
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Gender: All
Inclusion criteria:
• Established AIH confirmed according to simplified criteria (>6) (11) 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
• 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.
• Established AIH confirmed according to simplified criteria (>6) (11) 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
• 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-Primary biliary cholangitis, AIH-Primary sclerosing cholangitis)
• Child Pugh score > 7
• MELDNa score > 7
• Clinical evidence of decompensated 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 MD or WD.
• Concurrent diagnosis of celiac disease
• Concurrent use of dedicated dietary intervention (patient driven or else)
• Established diagnosis of variant syndrome (AIH-Primary biliary cholangitis, AIH-Primary sclerosing cholangitis)
• Child Pugh score > 7
• MELDNa score > 7
• Clinical evidence of decompensated 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 MD or WD.
Updated on
28 Apr 2024.
Study ID: GI-IIR-AIH-DIET, 20127
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