Bone HealthNCT05658159
Physiological and Dietary Characteristics of Boys and Girls High School Basketball Players
An observational study of Bone Health, run by PepsiCo Global R&D at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Health
- What is being tested?
- Vitamin D, DXA scan and Nutrition analysis
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 27 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Male and female high school basketball players
Who may be able to join
- 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.
Who cannot join
- Expulsion from school for any reason.
- Leaving the IMG basketball program.
- Pregnant or planning to become pregnant
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Bone Health
- Being tested
- Vitamin D, DXA scan, Nutrition analysis
- Keywords
- bone health, high school, diet, basketball, vitamin D, DXA, DEXA, nutrition, diet quality, energy intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDiagnostic test
Also called Vitamin D (25(OH)D)
Finger stick capillary blood sampling using test from ZRT Laboratories, Beaverton, OR
DXA scanDiagnostic test
Also called Dual Xray Absorptiometry
10 minute scan using scanner by GE Lunar, Madison, WI
Nutrition analysisOther
Analysis of 24-h recalls will be conducted by a registered dietician using Nutritionist Pro software by Axxya Systems, Redmond, WA
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
whole body
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Calcium intake via 24 hour recall and calcium supplement, if any
Measured: 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)
Magnesium intake via 24 hour recall and magnesium supplement, if any
Measured: 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)
Vitamin K intake via 24 hour recall and vitamin K supplement, if any
Measured: 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)
Protein intake via 24 hour recall
Measured: 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
Times of day protein is consumed
Measured: Changes from basketball pre-season (October 2022) to mid-season (January 2023) to post-season (April 2023). Looking at pattern of protein intake.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start1 Nov 2022
- Primary completion27 Apr 2023
- Study completion27 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kris Osterberg, PhD,RD,CSSD, Principal investigator, PepsiCo, Inc. Sports Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658159
- Sponsor's protocol ID
- PEP-2202
- Status last verified
- Jan 2024
- First submitted
- 9 Dec 2022
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological and Dietary Characteristics of Boys and Girls High School Basketball Players
- ClinicalTrials.gov ID
- NCT05658159
- Acronym / sponsor ID
- PEP-2202
- Conditions
- Bone Health
- Keywords
- bone health, high school, diet, basketball, vitamin D, DXA, DEXA, nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 20 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Male and female high school basketball players
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- Expulsion from school for any reason.
- Leaving the IMG basketball program.
- Pregnant or planning to become pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DAlso: Vitamin D (25(OH)D)Finger stick capillary blood sampling using test from ZRT Laboratories, Beaverton, OR | Diagnostic test | – |
| DXA scanAlso: Dual Xray Absorptiometry10 minute scan using scanner by GE Lunar, Madison, WI | Diagnostic test | – |
| Nutrition analysisAnalysis of 24-h recalls will be conducted by a registered dietician using Nutritionist Pro software by Axxya Systems, Redmond, WA | Other | – |
Primary outcome
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
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
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
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
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
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
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
5 secondary outcomes
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.
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.
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.
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 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kris Osterberg, PhD,RD,CSSD principal investigator
PepsiCo, Inc. Sports Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Health, run by PepsiCo Global R&D at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.