NCT06837376 · PepsiCo Global R&D
Effects of Metabolic Testing Data and Education on Attitudes and Beliefs Related to Carbohydrate Intake in Adolescent Female Athletes
What this study is about
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.
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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.
Interventions
OTHER
Education
One 45 minute educational session on the role of carbohydrate in exercise
OTHER
Metabolic Testing (Exercise) with shared interpreted results
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
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Females aged between the ages of 13-19 years old
- 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
Exclusion criteria
- 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
Where
- Bradenton, Florida
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 20, 2025 · Source of record for eligibility and locations