NCT05658159

Brief Summary

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. The secondary objectives are to assess 1) nutrients related to bone health (calcium, magnesium, vitamin K, protein) and 2) protein intake over the day. Data collection takes place pre-, mid-, and post-season.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 9, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 20, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2023

Completed
Last Updated

January 10, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

December 9, 2022

Last Update Submit

January 9, 2024

Conditions

Keywords

bone healthhigh schooldietbasketballvitamin DDXADEXAnutritiondiet qualityenergy intake

Outcome Measures

Primary Outcomes (7)

  • Bone mineral density

    whole body

    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.

  • Bone mineral density

    spine

    Changes from basketball pre-season (October 2022) to mid-season (January 2023) to post-season (April 2023). Normal spine bone density would be better.

  • Bone mineral density

    total hip

    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.

  • Bone mineral density

    femoral neck

    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.

  • Bone mineral density

    vitamin D status

    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.

  • Energy intake

    24 hour recall

    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.

  • Dietary quality

    24 hour recall

    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.

Secondary Outcomes (5)

  • Assess nutrients related to bone health (calcium)

    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.

  • Assess nutrients related to bone health (magnesium)

    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.

  • Assess nutrients related to bone health (vitamin K)

    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.

  • Assess nutrients related to bone health (protein)

    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.

  • Protein intake over the day

    Changes from basketball pre-season (October 2022) to mid-season (January 2023) to post-season (April 2023). Looking at pattern of protein intake.

Other Outcomes (4)

  • Assess frequency of consuming carbohydrate during training

    Changes from basketball pre-season (October 2022) to mid-season (January 2023) to post-season (April 2023). Looking at pattern of carbohydrate intake.

  • Assess current intake of supplements

    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.

  • Weight

    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.

  • +1 more other outcomes

Interventions

Vitamin DDIAGNOSTIC_TEST

Finger stick capillary blood sampling using test from ZRT Laboratories, Beaverton, OR

Also known as: Vitamin D (25(OH)D)
DXA scanDIAGNOSTIC_TEST

10 minute scan using scanner by GE Lunar, Madison, WI

Also known as: Dual Xray Absorptiometry

Analysis of 24-h recalls will be conducted by a registered dietician using Nutritionist Pro software by Axxya Systems, Redmond, WA

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Male and female high school basketball players

You may qualify if:

  • Females and males between the ages of 14-19 years old.
  • Non-smoker
  • Currently enrolled in the IMG basketball program.
  • Willing to fast overnight prior to testing.
  • Willing to do a finger stick for the Vitamin D assessment.
  • Able to give verbal and written informed consent for participation as well as obtain parental consent if \<18 years of age.
  • 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.

You may not qualify if:

  • Expulsion from school for any reason.
  • Leaving the IMG basketball program.
  • Pregnant or planning to become pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IMG Academy

Bradenton, Florida, 34210, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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)

MeSH Terms

Interventions

Vitamin D Response ElementAbsorptiometry, Photon

Intervention Hierarchy (Ancestors)

Response ElementsEnhancer Elements, GeneticRegulatory Sequences, Nucleic AcidBase SequenceMolecular StructureBiochemical PhenomenaChemical PhenomenaPromoter Regions, GeneticGenetic StructuresGenetic PhenomenaRegulatory Elements, TranscriptionalGene ComponentsGenesGenome ComponentsGenomeRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Kris Osterberg, PhD,RD,CSSD

    PepsiCo, Inc. Sports Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2022

First Posted

December 20, 2022

Study Start

November 1, 2022

Primary Completion

April 27, 2023

Study Completion

April 27, 2023

Last Updated

January 10, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations