Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-03-01 @ 1:46 PM
Study NCT ID:
NCT03100656
Status:
RECRUITING
Last Update Posted:
2023-11-13
First Post:
2017-03-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Food Aversion in Patients With Anorexia Nervosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000856', 'term': 'Anorexia Nervosa'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-09', 'studyFirstSubmitDate': '2017-03-03', 'studyFirstSubmitQcDate': '2017-03-28', 'lastUpdatePostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of metabolism biomarker', 'timeFrame': '2 hours', 'description': 'Percentage change of metabolism marker'}, {'measure': 'Food aversion/anxiety', 'timeFrame': '2 hours', 'description': 'Percentage change of food aversion/anxiety score'}], 'secondaryOutcomes': [{'measure': 'Weight', 'timeFrame': '6 and 12 months', 'description': 'Change in body weight, kg'}, {'measure': 'Psychopathology', 'timeFrame': '6 and 12 months', 'description': 'Percentage change in eating disorder psychopathology score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['psychopathology', 'treatment', 'epoxide hydrolases', 'polyunsaturated fatty acids', 'eicosanoids'], 'conditions': ['Anorexia Nervosa']}, 'referencesModule': {'references': [{'pmid': '28232135', 'type': 'BACKGROUND', 'citation': 'Shih PB. Integrating multi-omics biomarkers and postprandial metabolism to develop personalized treatment for anorexia nervosa. Prostaglandins Other Lipid Mediat. 2017 Sep;132:69-76. doi: 10.1016/j.prostaglandins.2017.02.002. Epub 2017 Feb 21.'}, {'pmid': '26944296', 'type': 'BACKGROUND', 'citation': 'Shih PA, Woodside DB. Contemporary views on the genetics of anorexia nervosa. Eur Neuropsychopharmacol. 2016 Apr;26(4):663-73. doi: 10.1016/j.euroneuro.2016.02.008. Epub 2016 Feb 20.'}, {'pmid': '25824304', 'type': 'BACKGROUND', 'citation': 'Shih PB, Yang J, Morisseau C, German JB, Zeeland AA, Armando AM, Quehenberger O, Bergen AW, Magistretti P, Berrettini W, Halmi KA, Schork N, Hammock BD, Kaye W. Dysregulation of soluble epoxide hydrolase and lipidomic profiles in anorexia nervosa. Mol Psychiatry. 2016 Apr;21(4):537-46. doi: 10.1038/mp.2015.26. Epub 2015 Mar 31.'}, {'pmid': '31540208', 'type': 'RESULT', 'citation': 'Nguyen N, Dow M, Woodside B, German JB, Quehenberger O, Shih PB. Food-Intake Normalization of Dysregulated Fatty Acids in Women with Anorexia Nervosa. Nutrients. 2019 Sep 13;11(9):2208. doi: 10.3390/nu11092208.'}], 'seeAlsoLinks': [{'url': 'https://g3garcia.wixsite.com/eatdisordersresearch', 'label': 'Food Aversion Study For Anorexia Nervosa at University of California, San Diego'}]}, 'descriptionModule': {'briefSummary': 'This study uses a meal-challenge protocol to assess if patients with anorexia nervosa show a differential metabolism in response to food in comparison to healthy controls. This study determines how heritable and biochemical factors influence food metabolism in anorexia nervosa in order to develop more effective treatment strategies.', 'detailedDescription': 'Anorexia nervosa is a brain-based disorder that often leads to serious health consequences including death. The EPHX2 gene has been identified as a susceptibility gene for anorexia nervosa. This study utilizes a multi-omics biomarker system approach to investigate how genetic factors interact with dietary factors to influence food aversion, psychopathology, and clinical outcome in patients with anorexia nervosa.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ill AN subjects will meet current Diagnostic and Statistical Manual of Mental Disorders (DSM V) diagnosis of AN, body mass index (BMI) between 11 kg/m² and 17.5 kg/m², or BMI \\> 17.5 kg/m² with active eating disorder symptoms.\n* Recovered AN must meet the following criteria at time of study entry: 1) Current or past DSM V diagnosis of AN; 2) BMI between 18.5 kg/m2 and 30 kg/m2; 3) Having maintained a BMI of \\>18.5 for at least one year.\n* Control must be healthy adolescent or woman negative on our screen for AN, other Axis I psychiatric illnesses, and having maintained a BMI of between 18.5-30 kg/m² since the age of 18.\n\nExclusion Criteria:\n\n* Exclusion criteria for AN and control subjects include: Organic brain syndrome, schizophrenia and schizoaffective disorder, untreated thyroid disease, renal disease, hepatic disease, and the regular use of fish-oil containing supplements within the last three months of the study. All pregnant and lactating individuals will be excluded.'}, 'identificationModule': {'nctId': 'NCT03100656', 'briefTitle': 'Study of Food Aversion in Patients With Anorexia Nervosa', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Solving EPHX2 and Polyunsaturated Fatty Acid Interactions in Anorexia Nervosa', 'orgStudyIdInfo': {'id': 'R01MH106781', 'link': 'https://reporter.nih.gov/quickSearch/R01MH106781', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Anorexia nervosa I', 'description': 'Anorexia nervosa with BMI \\<=17.5 kg/m² or BMI \\>17.5 kg/m² with regular binge-purge episodes', 'interventionNames': ['Other: A breakfast sandwich']}, {'type': 'OTHER', 'label': 'Anorexia nervosa II', 'description': 'Anorexia nervosa with BMI \\> 18.5 kg/m² for at least 12 months.', 'interventionNames': ['Other: A breakfast sandwich']}, {'type': 'OTHER', 'label': 'Controls', 'description': 'Healthy control women', 'interventionNames': ['Other: A breakfast sandwich']}], 'interventions': [{'name': 'A breakfast sandwich', 'type': 'OTHER', 'description': 'A meat-based breakfast sandwich', 'armGroupLabels': ['Anorexia nervosa I', 'Anorexia nervosa II', 'Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'P. Betty Shih, MPM, PhD', 'role': 'CONTACT', 'email': 'eatingdisorderresearch@ucsd.edu', 'phone': '858-534-0828'}, {'name': 'Pei-an Betty Shih, MPM, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UC San Diego Altman Clinical and Translational Research Institute', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'D. Blake Woodside', 'role': 'CONTACT', 'email': 'pbshih@ucsd.edu', 'phone': '416-340-4445'}, {'name': 'D. Blake Woodside, MD FRCPC', 'role': 'CONTACT', 'email': 'pbshih@ucsd.edu', 'phone': '416-340-4445'}, {'name': 'D. Blake Woodside, MD FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Pei-an (Betty) Shih, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Program for Eating Disorders, Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Pei-an (Betty) Shih, MPM, PhD', 'role': 'CONTACT', 'email': 'eatingdisorderresearch@ucsd.edu', 'phone': '(858) 534-0828'}, {'name': 'Nhien Nguyen, MS', 'role': 'CONTACT', 'email': 'n7nguyen@ucsd.edu'}], 'overallOfficials': [{'name': 'Pei-an (Betty) Shih, MPM, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Toronto', 'class': 'OTHER'}, {'name': 'University of California, Davis', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Pei-an (Betty) Shih', 'investigatorAffiliation': 'University of California, San Diego'}}}}