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Completed

NCT Number: 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.

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Key information

Conditions

Bone Health

Age range

14 year–19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IMG Academy

Bradenton, Florida, 34210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Diagnostic Test

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

Other names: Vitamin D (25(OH)D)

DXA scan

Diagnostic Test

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

Other names: Dual Xray Absorptiometry

Nutrition analysis

Other

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

Primary outcomes

  1. 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.

    whole body

  2. 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.

    spine

  3. 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.

    total hip

  4. 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.

    femoral neck

  5. 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.

    vitamin D status

  6. 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.

    24 hour recall

  7. 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.

    24 hour recall

Secondary outcomes

  1. 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.

    Calcium intake via 24 hour recall and calcium supplement, if any

  2. 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.

    Magnesium intake via 24 hour recall and magnesium supplement, if any

  3. 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.

    Vitamin K intake via 24 hour recall and vitamin K supplement, if any

  4. 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.

    Protein intake via 24 hour recall

  5. 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.

    Times of day protein is consumed

Other outcomes

  1. 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.

    Carbohydrate intake via 24 hour recall

  2. 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.

    Measure intake of supplements (pills, powders, gummies, etc.) via 24 hour recall and reported concomitant meds/supplements

  3. 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.

    Body weight scale accuracy to one tenth of a kilogram using a scale from data Weighing Systems, Wood Dale, IL

  4. 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.

    Participants standing and seated height will be measured by electronic stadiometry to the nearest cm using QuickMedical stadiometer, Warwick, RI

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 20, 2022
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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