Clinical trial NCT05658159: Physiological and Dietary Characteristics of Boys and Girls High School Basketball Players
Official title: Physiological and Dietary Characteristics of Boys and Girls High School Basketball Players
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Health
Keywords: bone health
high school
diet
basketball
vitamin D
DXA
DEXA
nutrition
diet quality
energy intake
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2022-12-20
Enrollment: 120
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female high school basketball players

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Females and males between the ages of 14-19 years old.
2. Non-smoker
3. Currently enrolled in the IMG basketball program.
4. Willing to fast overnight prior to testing.
5. Willing to do a finger stick for the Vitamin D assessment.
6. Able to give verbal and written informed consent for participation as well as obtain parental consent if \<18 years of age.
7. 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:

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

Primary outcomes:
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.
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.
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.
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.
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.
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.
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.
Secondary outcomes:
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.
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.
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.
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.
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.
Other outcomes:
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.
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.
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.
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.
Locations:
city: Bradenton
country: United States
facility: IMG Academy
state: Florida
Study officials:
affiliation: PepsiCo, Inc. Sports Science
name: Kris Osterberg, PhD,RD,CSSD
role: PRINCIPAL_INVESTIGATOR
References: