[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535321":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":35,"responsibleParty":56,"collaborators":24,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":24,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":24,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":38,"whyStopped":24,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Indiana University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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).",[13],"Dietary Supplement: Dietary assignment",{"label":15,"type":10,"description":16,"interventionNames":17},"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.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DIETARY_SUPPLEMENT","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.",[9,15],null,[26,31],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Kelsey Green, MPH","CONTACT","317-278-9292","greenke@iu.edu",{"name":32,"role":28,"phone":33,"phoneExt":24,"email":34},"Regina Weber, BS","317-278-3584","reginaw@iu.edu",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"IU Health University Hosptial","RECRUITING","Indianapolis","Indiana","46202","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-86.15804,39.76838,{"lat":48,"lon":47},[51,52,53],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},{"name":32,"role":28,"phone":33,"phoneExt":24,"email":34},{"name":54,"role":55,"phone":24,"phoneExt":24,"email":24},"Craig Lammert, MD","PRINCIPAL_INVESTIGATOR",{"type":55,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Craig Lammert","Associate Professor of Medicine","100535321","mediterranean-diet-versus-western-diet-on-fatigue-in-autoimmune-hepatitis-patients-100535321",false,"NCT06250309","Mediterranean Diet Versus Western Diet on Fatigue in Autoimmune Hepatitis Patients","Randomized Crossover Diet Study Comparing Impact of Mediterranean Diet to Western Diet on Fatigue in Autoimmune Hepatitis Patients","Inclusion Criteria:\n\n* Established autoimmune hepatitis (AIH) confirmed according to simplified criteria (\\>6) or historical confirmatory liver biopsy with inflammation consistent with AIH\n* Therapeutically stable AIH: no changes to immunosuppression (corticosteroids or baseline immunosuppression) within 4 weeks of study enrollment\n* Previous enrollment in the Indiana University GRACE study\n* Fatigue domain score (PROMIS-29) more than population mean (PROMIS 29 score): T-score ≥ 55\n* Diagnosis of AIH \\> 6 months\n* Current age: 18 to 80 years old\n* Willing and agree to comply with protocol requirements\n* 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)\n* Capable of storing 1 week duration of frozen food and preparing meals\n* Capable of receiving weekly frozen food on scheduled day of delivery\n* Capable of understanding and signing the informed consent document\n\nExclusion Criteria:\n\n* Concurrent diagnosis of celiac disease\n* Concurrent use of dedicated dietary intervention (patient driven or else)\n* Established diagnosis of variant syndrome (AIH with Primary biliary cholangitis, AIH with Primary sclerosing cholangitis)\n* Child Pugh score \\> 7\n* MELDNa score \\> 7\n* Clinical evidence of de-compensated cirrhosis: ascites, total bilirubin \\>1.5, large esophageal varices or history of bleeding, known diagnosis of hepatic encephalopathy\n* 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\n* History of liver transplantation\n* Current treatment with an investigational drug\n* Historical intolerance or allergy to foods included in a Mediterranean Diet or a Western Diet","ALL","18 Years","80 Years",{"count":70,"type":71},48,"ESTIMATED","INTERVENTIONAL",[74],"NA","This is a single-center, proof-of-concept pilot study which uses a cross-over design to compare two dietary interventions\u002Ftreatments: 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.",[77],"Autoimmune Hepatitis",[79],"fatigue","2026-05-05",{"date":82,"type":83},"2026-05-08","ACTUAL",{"date":85,"type":83},"2023-10-23",{"date":87,"type":71},"2028-12-31",{"name":5,"class":6},1]