- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05658159
Physiological and Dietary Characteristics of Boys and Girls High School Basketball Players
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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).
Investigators hypothesize that vitamin D status will be suboptimal in most participants though bone density will be normal.
Investigators 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Florida
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Bradenton, Florida, United States, 34210
- IMG Academy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Expulsion from school for any reason.
- Leaving the IMG basketball program.
- Pregnant or planning to become pregnant
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bone mineral density
Time Frame: 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.
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whole body
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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.
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Bone mineral density
Time Frame: Changes from basketball pre-season (October 2022) to mid-season (January 2023) to post-season (April 2023). Normal spine bone density would be better.
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spine
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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
Time Frame: 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.
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total hip
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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.
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Bone mineral density
Time Frame: 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.
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femoral neck
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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
Time Frame: 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.
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vitamin D status
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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
Time Frame: 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.
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24 hour recall
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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.
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|
Dietary quality
Time Frame: 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.
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24 hour recall
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess nutrients related to bone health (calcium)
Time Frame: 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.
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Calcium intake via 24 hour recall and calcium supplement, if any
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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.
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Assess nutrients related to bone health (magnesium)
Time Frame: 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.
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Magnesium intake via 24 hour recall and magnesium supplement, if any
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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.
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Assess nutrients related to bone health (vitamin K)
Time Frame: 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.
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Vitamin K intake via 24 hour recall and vitamin K supplement, if any
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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.
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|
Assess nutrients related to bone health (protein)
Time Frame: 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.
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Protein intake via 24 hour recall
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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.
|
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Protein intake over the day
Time Frame: Changes from basketball pre-season (October 2022) to mid-season (January 2023) to post-season (April 2023). Looking at pattern of protein intake.
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Times of day protein is consumed
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Changes from basketball pre-season (October 2022) to mid-season (January 2023) to post-season (April 2023). Looking at pattern of protein intake.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess frequency of consuming carbohydrate during training
Time Frame: Changes from basketball pre-season (October 2022) to mid-season (January 2023) to post-season (April 2023). Looking at pattern of carbohydrate intake.
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Carbohydrate intake via 24 hour recall
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Changes from basketball pre-season (October 2022) to mid-season (January 2023) to post-season (April 2023). Looking at pattern of carbohydrate intake.
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Assess current intake of supplements
Time Frame: 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.
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Measure intake of supplements (pills, powders, gummies, etc.) via 24 hour recall and reported concomitant meds/supplements
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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.
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Weight
Time Frame: 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.
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Body weight scale accuracy to one tenth of a kilogram using a scale from data Weighing Systems, Wood Dale, IL
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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.
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Height
Time Frame: Changes from basketball pre-season (October 2022) to mid-season (January 2023) to post-season (April 2023). Better or worse direction not applicable.
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Participants standing and seated height will be measured by electronic stadiometry to the nearest cm using QuickMedical stadiometer, Warwick, RI
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Changes from basketball pre-season (October 2022) to mid-season (January 2023) to post-season (April 2023). Better or worse direction not applicable.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kris Osterberg, PhD,RD,CSSD, PepsiCo, Inc. Sports Science
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PEP-2202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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