Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-02-25 @ 5:42 PM
Study NCT ID:
NCT04408833
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-07
First Post:
2020-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Palmitate Study: A Method Study of Dietary Lipid Oxidation in Toddlers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-05', 'studyFirstSubmitDate': '2020-05-26', 'studyFirstSubmitQcDate': '2020-05-26', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'How toddlers burn fat', 'timeFrame': '24 hours', 'description': 'collect urine'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to measure how toddlers burn fat after drinking milk that has some fat molecules that can be tracked based on how heavy they are.', 'detailedDescription': 'The purpose of this research is to measure how toddlers burn fat after drinking milk that has some fat molecules that can be tracked based on how heavy they are. These molecules are not dangerous. By collecting several urine samples throughout a 24-hour window (about 7 urine samples or more) after drinking the fat molecules, we will be able to measure how fast your toddler is sending out (excreting) these samples in the urine. This will tell us how fast your toddler is using fat for energy. This will also help determine the best urine collection schedule for studies using this technology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '25 Months', 'minimumAge': '23 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '10 toddlers approximately two years of age from ongoing studies or as a new participant from the community', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* Male or female\n* Toilet trained or not\n\nExclusion Criteria:\n\n* Diagnosed metabolic disease'}, 'identificationModule': {'nctId': 'NCT04408833', 'briefTitle': 'Palmitate Study: A Method Study of Dietary Lipid Oxidation in Toddlers', 'organization': {'class': 'OTHER', 'fullName': "Arkansas Children's Hospital Research Institute"}, 'officialTitle': 'Measurement of Dietary Lipid Oxidation in Toddlers - a Method Study', 'orgStudyIdInfo': {'id': '249922'}}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Nutrition Center", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'overallOfficials': [{'name': 'Elisabet Borsheim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Arkansas Children's Research Institute"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Arkansas Children's Hospital Research Institute", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}