Nutritional DeficiencyNCT06837376
Effects of Metabolic Testing Data and Education on Attitudes and Beliefs Related to Carbohydrate Intake in Adolescent Female Athletes
A study testing Education and Metabolic Testing (Exercise) with shared interpreted results in people with Nutritional Deficiency, run by PepsiCo Global R&D at 1 site in United States.
Trial summary
Many studies have consistently shown that females across sports under consume carbohydrate. Registered dietitians working with athletes have also reported female athletes chronically under consume carbohydrate. Read more about this study
- Who is it for?
- Ages 13 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nutritional Deficiency
- What is being tested?
- Education and Metabolic Testing (Exercise) with shared interpreted results
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2025to 6 May 2026
- Phase
- Interventional
- 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 13 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Females aged between the ages of 13-19 years old
- Non-smoker
- Currently enrolled in an IMG Academy sport
- Willing to fast overnight (10 hours) prior to testing (for metabolic testing group).
- Understand the protocol and be able to give verbal and written informed consent for participation as well as obtain parental consent if <18 years of age.
- Must be fluent in English reading, writing, and speaking.
- You are not employed by, or have a parent, guardian, or other immediate family member employed by a company that manufactures any products that compete with any Gatorade product. If you are unsure if a company would be considered a competitor to Gatorade, let the study investigator know the name of the other company and the nature of your relationship to that company before you sign the informed consent
- If subject has asthma, they may still participate in but will be required to bring their prescribed inhaler if placed in the metabolic testing group
Who cannot join
- Expulsion from school for any reason
- Leaving the IMG sports team
- Pregnant or planning to become pregnant
- Participated in any other clinical trial in the past 30 day
- Participated in any PepsiCo trial in the past 6 months
- Physical injury that would prevent participation in exercise group
Trial locations and contacts
1 site in 1 country.
United States1 site
Gatorade Sports Science Institute at IMG Academy
Bradenton, Florida, 34210
About this study
Many studies have consistently shown that females across sports under consume carbohydrate. Registered dietitians working with athletes have also reported female athletes chronically under consume carbohydrate. The primary objective of this study is to compare the effectiveness of education versus education plus interpreted individual metabolic (exercise) testing results to change attitudes and beliefs of female athletes regarding carbohydrate intake. The secondary objective is to assess the effectiveness of the education alone on attitudes and beliefs towards consuming carbohydrate in female athletes.
The study hypothesis is that education alone will not significantly impact attitudes and beliefs, and that metabolic testing and the interpretation of the individual results will alter attitudes and beliefs toward carbohydrate intake.
- Conditions
- Nutritional Deficiency
- Being tested
- Education, Metabolic Testing (Exercise) with shared interpreted results
- Keywords
- exercise performance, metabolic testing, education, carbohydrate, adolescent, female, athlete
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
One 45 minute educational session on the role of carbohydrate in exercise
Metabolic Testing (Exercise) with shared interpreted resultsOther
One 20-30 minute session. Treadmill, warm-up, then at increasing intensities for 3-minute intervals wearing a mouthpiece for measurement of respiratory gasses (oxygen consumption, carbon dioxide production). Testing starts with a 3-minute warm-up at 3.4 mph, 1% grade, increasing every 3 minutes until a respiratory exchange ratio of 1.0 is reached or volitional exhaustion
| Study group | Role | What they receive |
|---|---|---|
| Education plus metabolic testing | Other | Classroom session with slides and videos. Exercise with shared exercise data. Receives: Other: Education; Other: Metabolic Testing (Exercise) with shared interpreted results |
| Education only | Other | Classroom session with slides and videos. Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Education versus Education plus metabolic testing
To compare the effectiveness of education alone versus education plus interpreted individual metabolic testing results to change attitudes and beliefs of female athletes regarding carbohydrate intake.
Measured: Change in Nutrition Attitudes Questionnaire score from Baseline visit to same questionnaire re-taken 2 weeks later. For each questionnaire, a higher score will be correlated to more positive sentiments around carbohydrate intake.
Secondary outcomes (1)
Education alone
Within the education only group
Measured: Change in Nutrition Attitudes Questionnaire score from Baseline visit to same questionnaire re-taken 2 weeks later. A higher score will be correlated to more positive sentiments around carbohydrate intake.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start5 Feb 2025
- Primary completion6 May 2026
- Study completion6 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional DeficiencyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 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, Principal investigator, PepsiCo R&D Life Sciences, Sports Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837376
- Sponsor's protocol ID
- PEP-2408
- Status last verified
- Sep 2026
- First submitted
- 14 Feb 2025
- Last updated
- 16 Sep 2026
- Results posted
- 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 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Metabolic Testing Data and Education on Attitudes and Beliefs Related to Carbohydrate Intake in Adolescent Female Athletes
- ClinicalTrials.gov ID
- NCT06837376
- Acronym / sponsor ID
- PEP-2408
- Conditions
- Nutritional Deficiency
- Keywords
- exercise performance, metabolic testing, education, carbohydrate, adolescent, female, athlete
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 6 May 2026 (actual)
- Study completion
- 6 May 2026 (actual)
- First posted
- 20 Feb 2025 (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.
Many studies have consistently shown that females across sports under consume carbohydrate. Registered dietitians working with athletes have also reported female athletes chronically under consume carbohydrate. The primary objective of this study is to compare the effectiveness of education versus education plus interpreted individual metabolic (exercise) testing results to change attitudes and beliefs of female athletes regarding carbohydrate intake. The secondary objective is to assess the effectiveness of the education alone on attitudes and beliefs towards consuming carbohydrate in female athletes.
The study hypothesis is that education alone will not significantly impact attitudes and beliefs, and that metabolic testing and the interpretation of the individual results will alter attitudes and beliefs toward carbohydrate intake.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education plus metabolic testing | Other | Other: Education, Other: Metabolic Testing (Exercise) with shared interpreted resultsClassroom session with slides and videos. Exercise with shared exercise data. |
| Education only | Other | Other: EducationClassroom session with slides and videos. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Females aged between the ages of 13-19 years old
- Non-smoker
- Currently enrolled in an IMG Academy sport
- Willing to fast overnight (10 hours) prior to testing (for metabolic testing group).
- Understand the protocol and be able to give verbal and written informed consent for participation as well as obtain parental consent if <18 years of age.
Key exclusion criteria (6 listed)
- Expulsion from school for any reason
- Leaving the IMG sports team
- Pregnant or planning to become pregnant
- Participated in any other clinical trial in the past 30 day
- Participated in any PepsiCo trial in the past 6 months
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 |
|---|---|---|
| EducationOne 45 minute educational session on the role of carbohydrate in exercise | Other | Education only, Education plus metabolic testing |
| Metabolic Testing (Exercise) with shared interpreted resultsOne 20-30 minute session. Treadmill, warm-up, then at increasing intensities for 3-minute intervals wearing a mouthpiece for measurement of respiratory gasses (oxygen consumption, carbon dioxide production). Testing starts with a 3-minute warm-up at 3.4 mph, 1% grade, increasing every 3 minutes until a respiratory exchange ratio of 1.0 is reached or volitional exhaustion | Other | Education plus metabolic testing |
Primary outcome
Education versus Education plus metabolic testing
Time frame: Change in Nutrition Attitudes Questionnaire score from Baseline visit to same questionnaire re-taken 2 weeks later. For each questionnaire, a higher score will be correlated to more positive sentiments around carbohydrate intake.
To compare the effectiveness of education alone versus education plus interpreted individual metabolic testing results to change attitudes and beliefs of female athletes regarding carbohydrate intake.
1 secondary outcome
Education alone
Time frame: Change in Nutrition Attitudes Questionnaire score from Baseline visit to same questionnaire re-taken 2 weeks later. A higher score will be correlated to more positive sentiments around carbohydrate 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 16 Sep 2026.
- 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 principal investigator
PepsiCo R&D Life Sciences, Sports Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and Metabolic Testing (Exercise) with shared interpreted results in people with Nutritional Deficiency, 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 8 inclusion and 6 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 16 Sep 2026. 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?
Education versus Education plus metabolic testing (time frame: Change in Nutrition Attitudes Questionnaire score from Baseline visit to same questionnaire re-taken 2 weeks later. For each questionnaire, a higher score will be correlated to more positive sentiments around carbohydrate intake.). 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 16 Sep 2026.