Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-01-05 @ 6:09 PM
Study NCT ID:
NCT03518892
Status:
COMPLETED
Last Update Posted:
2020-12-16
First Post:
2018-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing Dietary Requirements in Relation to Resting Metabolic Rate in Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001481', 'term': 'Basal Metabolism'}, {'id': 'D001823', 'term': 'Body Composition'}, {'id': 'D015596', 'term': 'Nutrition Assessment'}], 'ancestors': [{'id': 'D004734', 'term': 'Energy Metabolism'}, {'id': 'D008660', 'term': 'Metabolism'}, {'id': 'D001669', 'term': 'Biochemical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}, {'id': 'D001824', 'term': 'Body Constitution'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-11', 'studyFirstSubmitDate': '2018-04-11', 'studyFirstSubmitQcDate': '2018-04-25', 'lastUpdatePostDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Body fat', 'timeFrame': 'Week 2'}, {'measure': 'Fat Free Mass', 'timeFrame': 'Week 2', 'description': 'lbs'}, {'measure': 'Fat Mass', 'timeFrame': 'Week 2', 'description': 'lbs'}, {'measure': 'Resting Metabolic Rate', 'timeFrame': 'Week 2'}, {'measure': 'Dietary Assessment Using Self-Reported Diary Questionaire', 'timeFrame': 'Week 2', 'description': 'Dietary information will be collected from the participants using a self-reported food frequency diary questionnaire. The diary will log food, amount eaten, how it was prepared, and brand name of participant food intake at breakfast, lunch, snacks, and dinner.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Resting Metabolic Rate'], 'conditions': ['Spinal Cord Injuries', 'Dietary Habits']}, 'descriptionModule': {'briefSummary': 'Assess the relationship between body composition, metabolism, and dietary needs in people with spinal cord injury compared to their healthy controls that are age and sex matched.', 'detailedDescription': 'This study will quantify body composition and resting metabolic rate and then compare these parameters to results from a nutritional analysis. Participants will have two study visits that include physical exam, blood draws, resting metabolic rate, Dual Energy X-ray Absorptiometry (DXA) scan, and dietary assessments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Spinal Cord Injury subjects and healthy controls across central Pennsylvania.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. C4-L2 motor complete (AIS A \\& B) Spinal Cord injury for duration greater than 12 months.\n\n4\\. \\<5% change in body in body weight over the past 12 months 5. Fluent in written and spoken English\n\nExclusion Criteria:\n\n1. \\<22% body fat\n2. Coronary artery disease\n3. Type 1 diabetes mellitus, insulin-requiring Type 2 or untreated diabetes mellitus (fasting glucose\\>126 or HgbA1c\\>7.0)\n4. Hypothyroidism, and/or renal disease\n5. Decisional impairment\n6. Prisoner'}, 'identificationModule': {'nctId': 'NCT03518892', 'briefTitle': 'Assessing Dietary Requirements in Relation to Resting Metabolic Rate in Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Assessing Dietary Requirements in Relation to Resting Metabolic Rate in Spinal Cord Injury', 'orgStudyIdInfo': {'id': '7333'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Spinal Cord Injury Group', 'description': 'Body Composition, Resting Metabolic Rate, and dietary assessment', 'interventionNames': ['Diagnostic Test: Resting Metabolic Rate', 'Diagnostic Test: Body Composition', 'Behavioral: Dietary Assessment']}, {'label': 'Healthy Controls', 'description': 'Body Composition, Resting Metabolic Rate, and dietary assessment', 'interventionNames': ['Diagnostic Test: Resting Metabolic Rate', 'Diagnostic Test: Body Composition', 'Behavioral: Dietary Assessment']}], 'interventions': [{'name': 'Resting Metabolic Rate', 'type': 'DIAGNOSTIC_TEST', 'description': '30 minute test to determine daily caloric needs', 'armGroupLabels': ['Healthy Controls', 'Spinal Cord Injury Group']}, {'name': 'Body Composition', 'type': 'DIAGNOSTIC_TEST', 'description': 'Total Body DXA scan to determine fat mass, fat-free mass, and percent body fat', 'armGroupLabels': ['Healthy Controls', 'Spinal Cord Injury Group']}, {'name': 'Dietary Assessment', 'type': 'BEHAVIORAL', 'description': 'Self administered dietary logs', 'armGroupLabels': ['Healthy Controls', 'Spinal Cord Injury Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'overallOfficials': [{'name': 'David Gater, MD, PhD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Milton S. Hershey Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}