Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2026-02-20 @ 6:34 PM
Study NCT ID:
NCT05658159
Status:
COMPLETED
Last Update Posted:
2024-01-10
First Post:
2022-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physiological and Dietary Characteristics of Boys and Girls High School Basketball Players
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D030181', 'term': 'Vitamin D Response Element'}, {'id': 'D015502', 'term': 'Absorptiometry, Photon'}], 'ancestors': [{'id': 'D020218', 'term': 'Response Elements'}, {'id': 'D004742', 'term': 'Enhancer Elements, Genetic'}, {'id': 'D012045', 'term': 'Regulatory Sequences, Nucleic Acid'}, {'id': 'D001483', 'term': 'Base Sequence'}, {'id': 'D015394', 'term': 'Molecular Structure'}, {'id': 'D001669', 'term': 'Biochemical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}, {'id': 'D011401', 'term': 'Promoter Regions, Genetic'}, {'id': 'D040342', 'term': 'Genetic Structures'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D050436', 'term': 'Regulatory Elements, Transcriptional'}, {'id': 'D040461', 'term': 'Gene Components'}, {'id': 'D005796', 'term': 'Genes'}, {'id': 'D040481', 'term': 'Genome Components'}, {'id': 'D016678', 'term': 'Genome'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003720', 'term': 'Densitometry'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Vitamin D Assessment: ZRT Laboratories, Beaverton, OR. A finger stick will be used to obtain a capillary blood sample for assessment of Vitamin D (25(OH)D)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-09', 'studyFirstSubmitDate': '2022-12-09', 'studyFirstSubmitQcDate': '2022-12-19', 'lastUpdatePostDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assess frequency of consuming carbohydrate during training', 'timeFrame': 'Changes from basketball pre-season (October 2022) to mid-season (January 2023) to post-season (April 2023). Looking at pattern of carbohydrate intake.', 'description': 'Carbohydrate intake via 24 hour recall'}, {'measure': 'Assess current intake of supplements', 'timeFrame': 'Changes from basketball pre-season (October 2022) to mid-season (January 2023) to post-season (April 2023) in consumption of supplements. Better or worse outcome not applicable.', 'description': 'Measure intake of supplements (pills, powders, gummies, etc.) via 24 hour recall and reported concomitant meds/supplements'}, {'measure': 'Weight', 'timeFrame': 'Changes from basketball pre-season (October 2022) to mid-season (January 2023) to post-season (April 2023). No desired direction of change, expecting it to remain contstant.', 'description': 'Body weight scale accuracy to one tenth of a kilogram using a scale from data Weighing Systems, Wood Dale, IL'}, {'measure': 'Height', 'timeFrame': 'Changes from basketball pre-season (October 2022) to mid-season (January 2023) to post-season (April 2023). Better or worse direction not applicable.', 'description': 'Participants standing and seated height will be measured by electronic stadiometry to the nearest cm using QuickMedical stadiometer, Warwick, RI'}], 'primaryOutcomes': [{'measure': 'Bone mineral density', 'timeFrame': 'Changes from basketball pre-season (October 2022) to mid-season (January 2023) to post-season (April 2023). Normal whole body bone density would be better.', 'description': 'whole body'}, {'measure': 'Bone mineral density', 'timeFrame': 'Changes from basketball pre-season (October 2022) to mid-season (January 2023) to post-season (April 2023). Normal spine bone density would be better.', 'description': 'spine'}, {'measure': 'Bone mineral density', 'timeFrame': 'Changes from basketball pre-season (October 2022) to mid-season (January 2023) to post-season (April 2023). Normal total hip bone density would be better.', 'description': 'total hip'}, {'measure': 'Bone mineral density', 'timeFrame': 'Changes from basketball pre-season (October 2022) to mid-season (January 2023) to post-season (April 2023). Normal femoral neck bone density would be better.', 'description': 'femoral neck'}, {'measure': 'Bone mineral density', 'timeFrame': 'Changes from basketball pre-season (October 2022) to mid-season (January 2023) to post-season (April 2023). Adequacy will be defined as a value > 32 ng/mL. Higher Vitamin D values would be better.', 'description': 'vitamin D status'}, {'measure': 'Energy intake', 'timeFrame': 'Changes from basketball pre-season (October 2022) to mid-season (January 2023) to post-season (April 2023). Energy intake that meets recommendations would be better.', 'description': '24 hour recall'}, {'measure': 'Dietary quality', 'timeFrame': 'Changes from basketball pre-season (October 2022) to mid-season (January 2023) to post-season (April 2023). Diet quality that meets recommendations would be better.', 'description': '24 hour recall'}], 'secondaryOutcomes': [{'measure': 'Assess nutrients related to bone health (calcium)', 'timeFrame': 'Changes from basketball pre-season (October 2022) to mid-season (January 2023) to post-season (April 2023). Calcium intake that meets recommendations would be better.', 'description': 'Calcium intake via 24 hour recall and calcium supplement, if any'}, {'measure': 'Assess nutrients related to bone health (magnesium)', 'timeFrame': 'Changes from basketball pre-season (October 2022) to mid-season (January 2023) to post-season (April 2023). Magnesium intake that meets recommendations would be better.', 'description': 'Magnesium intake via 24 hour recall and magnesium supplement, if any'}, {'measure': 'Assess nutrients related to bone health (vitamin K)', 'timeFrame': 'Changes from basketball pre-season (October 2022) to mid-season (January 2023) to post-season (April 2023). Vitamin K intake that meets recommendations would be better.', 'description': 'Vitamin K intake via 24 hour recall and vitamin K supplement, if any'}, {'measure': 'Assess nutrients related to bone health (protein)', 'timeFrame': 'Changes from basketball pre-season (October 2022) to mid-season (January 2023) to post-season (April 2023). Protein intake that meets recommendations would be better.', 'description': 'Protein intake via 24 hour recall'}, {'measure': 'Protein intake over the day', 'timeFrame': 'Changes from basketball pre-season (October 2022) to mid-season (January 2023) to post-season (April 2023). Looking at pattern of protein intake.', 'description': 'Times of day protein is consumed'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bone health', 'high school', 'diet', 'basketball', 'vitamin D', 'DXA', 'DEXA', 'nutrition', 'diet quality', 'energy intake'], 'conditions': ['Bone Health']}, 'descriptionModule': {'briefSummary': 'In a population of boys and girls high school basketball players, the primary objectives are to assess 1) bone mineral density and vitamin D status, and 2) energy intake and dietary quality.\n\nThe secondary objectives are to assess 1) nutrients related to bone health (calcium, magnesium, vitamin K, protein) and 2) protein intake over the day.\n\nData collection takes place pre-, mid-, and post-season.', 'detailedDescription': 'This study will assess the dietary intake male and female 14-19 year old student athletes, specifically energy intake and dietary quality (i.e. how closely do their diets meet recommendations).\n\nInvestigators hypothesize that vitamin D status will be suboptimal in most participants though bone density will be normal.\n\nInvestigators hypothesize that participants will maintain energy balance over the course of the season (no significant changes to body mass or body composition) but dietary quality will not meet recommendations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male and female high school basketball players', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Females and males between the ages of 14-19 years old.\n2. Non-smoker\n3. Currently enrolled in the IMG basketball program.\n4. Willing to fast overnight prior to testing.\n5. Willing to do a finger stick for the Vitamin D assessment.\n6. Able to give verbal and written informed consent for participation as well as obtain parental consent if \\<18 years of age.\n7. If an athlete would like to participate but English is not their first language, we will liaise with an interpreter on the IMG campus to inform him / her of the study protocol and procedures.\n\nExclusion Criteria:\n\n1. Expulsion from school for any reason.\n2. Leaving the IMG basketball program.\n3. Pregnant or planning to become pregnant'}, 'identificationModule': {'nctId': 'NCT05658159', 'briefTitle': 'Physiological and Dietary Characteristics of Boys and Girls High School Basketball Players', 'organization': {'class': 'INDUSTRY', 'fullName': 'PepsiCo Global R&D'}, 'officialTitle': 'Physiological and Dietary Characteristics of Boys and Girls High School Basketball Players', 'orgStudyIdInfo': {'id': 'PEP-2202'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Vitamin D', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Vitamin D (25(OH)D)'], 'description': 'Finger stick capillary blood sampling using test from ZRT Laboratories, Beaverton, OR'}, {'name': 'DXA scan', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Dual Xray Absorptiometry'], 'description': '10 minute scan using scanner by GE Lunar, Madison, WI'}, {'name': 'Nutrition analysis', 'type': 'OTHER', 'description': 'Analysis of 24-h recalls will be conducted by a registered dietician using Nutritionist Pro software by Axxya Systems, Redmond, WA'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34210', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'IMG Academy', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}], 'overallOfficials': [{'name': 'Kris Osterberg, PhD,RD,CSSD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PepsiCo, Inc. Sports Science'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PepsiCo Global R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}