Physiological and Dietary Characteristics of Boys and Girls High School Basketball Players

Bone Health Clinical Trial

Official title:

Physiological and Dietary Characteristics of Boys and Girls High School Basketball Players

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05658159
• Other study ID #: PEP-2202
• Status: Completed
• Start date: November 1, 2022
• Est. completion date: April 27, 2023

Study information

• Verified date: January 2024
• Source: PepsiCo Global R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 27, 2023
• Est. primary completion date: April 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Health

Intervention

Diagnostic Test:
• Vitamin D
Finger stick capillary blood sampling using test from ZRT Laboratories, Beaverton, OR
• DXA scan
10 minute scan using scanner by GE Lunar, Madison, WI

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

Locations

Country	Name	City	State
United States	IMG Academy	Bradenton	Florida

Sponsors (1)

Lead Sponsor	Collaborator
PepsiCo Global R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assess frequency of consuming carbohydrate during training	Carbohydrate intake via 24 hour recall	Changes from basketball pre-season (October 2022) to mid-season (January 2023) to post-season (April 2023). Looking at pattern of carbohydrate intake.
Other	Assess current intake of supplements	Measure intake of supplements (pills, powders, gummies, etc.) via 24 hour recall and reported concomitant meds/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.
Other	Weight	Body weight scale accuracy to one tenth of a kilogram using a scale from data Weighing Systems, Wood Dale, IL	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.
Other	Height	Participants standing and seated height will be measured by electronic stadiometry to the nearest cm using QuickMedical stadiometer, Warwick, RI	Changes from basketball pre-season (October 2022) to mid-season (January 2023) to post-season (April 2023). Better or worse direction not applicable.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	Assess nutrients related to bone health (calcium)	Calcium intake via 24 hour recall and calcium supplement, if any	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.
Secondary	Assess nutrients related to bone health (magnesium)	Magnesium intake via 24 hour recall and magnesium supplement, if any	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.
Secondary	Assess nutrients related to bone health (vitamin K)	Vitamin K intake via 24 hour recall and vitamin K supplement, if any	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.
Secondary	Assess nutrients related to bone health (protein)	Protein intake via 24 hour recall	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.
Secondary	Protein intake over the day	Times of day protein is consumed	Changes from basketball pre-season (October 2022) to mid-season (January 2023) to post-season (April 2023). Looking at pattern of protein intake.