Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2026-01-01 @ 11:17 AM
Study NCT ID:
NCT05799768
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-02-07
First Post:
2023-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ketogenic Diet in Rheumatoid Arthritis (RA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055423', 'term': 'Diet, Ketogenic'}], 'ancestors': [{'id': 'D050528', 'term': 'Diet, Carbohydrate-Restricted'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-05', 'studyFirstSubmitDate': '2023-03-23', 'studyFirstSubmitQcDate': '2023-03-23', 'lastUpdatePostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hsCRP', 'timeFrame': '6 weeks', 'description': 'Systemic marker of inflammation'}], 'secondaryOutcomes': [{'measure': 'DAS28-CRP', 'timeFrame': '6 weeks', 'description': 'RA disease activity measure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis', 'Inflammation', 'Obesity', 'Ketogenic Dieting', 'Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'This is a 6-week ketogenic diet (KD) intervention where participants with rheumatoid arthritis (RA) will follow a KD plan, supervised and monitored by a dietician. Participants will be provided extensive educational and ongoing support on the KD, including personalized coaching with the ability to text a dietitian at any time and expect a response within 12 hours. Diet adherence and progress will be assessed daily using at-home blood ketone/glucose monitors, along with diet records. Participants will fill out health related questionnaires and undergo assessments of body composition, RA disease activity. This study also includes blood draws and fat biopsy of the abdominal region.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of RA according to the ACR/EULAR 2010 criteria for RA.\n* On stable doses of DMARDs and/ or biological agents (≥ 2 months prior to study enrollment)\n\nExclusion Criteria:\n\n* Chronic inflammatory/ autoimmune disease other than RA (e.g. gout, inflammatory bowel disease such as Crohn's disease or ulcerative colitis, lupus, myositis, etc.)\n* Prednisone or other glucocorticoid use in the last 4 weeks (exception: intra-articular glucocorticoid injections)\n* Insulin use\n* Hospitalization in the 30 days prior to study enrollment\n* Acute or uncontrolled disease (e.g. cirrhosis, COPD, CKD)\n* Malignancy\n* Chronic infection (HIV, hep B/C, etc.)\n* Heavy drinking\n* On a ketogenic diet or exogenous ketone supplement (lses than 3 months prior to study enrollment)\n* Recent weight loss (\\>5% in the last 2 months)"}, 'identificationModule': {'nctId': 'NCT05799768', 'acronym': 'KETORA', 'briefTitle': 'Ketogenic Diet in Rheumatoid Arthritis (RA)', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Ketogenic Diet Intervention in Patients With Rheumatoid Arthritis (RA): a Pilot Study', 'orgStudyIdInfo': {'id': '2020H0090'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketogenic diet plan', 'description': 'Subjects will be provided extensive educational and ongoing support on the KD, including personalized coaching with the ability to text a dietitian at any time and expect a response within 12 hours. Diet adherence and progress will be assessed daily using at-home whole capillary blood ketone/glucose monitors, along with diet records. We will assess adherence based on days in ketosis following these parameters: (BHB ≥ 0.5mM). Adherence will be defined as \\> 80% of days in ketosis.', 'interventionNames': ['Behavioral: Ketogenic diet']}], 'interventions': [{'name': 'Ketogenic diet', 'type': 'BEHAVIORAL', 'description': 'Ketogenic diet counseling', 'armGroupLabels': ['Ketogenic diet plan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73003', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma University Health Sciences Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rheumatology Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}