Mediterranean Diet Versus Western Diet on Fatigue in Autoimmune Hepatitis Patients
ConditionAutoimmune Hepatitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorIndiana University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Dietary assignment
Dietary supplementA 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.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Mediterranean Diet (MD)Active comparator 1 intervention
Group B: Western Diet (WD)Active comparator 1 intervention
Trial outcomes
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.
Time frame
24 weeksSecondary outcomes
1
Change in overall health related quality of life 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.
Time frame
24 weeks2
Changes in liver stiffness and fat content via transient elastography
Assessment from the patient only as measured by VCTE (vibration controlled transient elastography) via FibroScan® and with bioelectrical impedance via INBody®measure. A higher score equals more liver steatosis and fibrosis.
Time frame
24 weeks3
Change in alanine transaminase (ALT) value
Assessment from the patient only through lab results taken from a venous blood draw.
Time frame
24 weeks4
Change in IgG value
Assessment from the patient only through lab results taken from a venous blood draw.
Time frame
24 weeksSponsors and contacts
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Source ClinicalTrials.gov