Recruiting

Metabolic Testing

Sponsor:

PepsiCo Global R&D

Code:

NCT06837376

Conditions

Nutritional Deficiency

Eligibility Criteria

Sex: Female

Age: 13 - 19

Healthy Volunteers: Accepted

Interventions

Education

Metabolic Testing (Exercise) with shared interpreted results

Study Details

Brief 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. 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

Study ID

NCT06837376

Start date

Feb 5, 2025

Status verified date

Feb, 2025

Completion date

May 15, 2025

Anticipated

Primary completion date

May 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 13 - 19

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Females aged between the ages of 13-19 years old
2. Non-smoker
3. Currently enrolled in an IMG Academy sport
4. Willing to fast overnight (10 hours) prior to testing (for metabolic testing group).
5. 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.
6. Must be fluent in English reading, writing, and speaking.
7. 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
8. 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:

1. Expulsion from school for any reason
2. Leaving the IMG sports team
3. Pregnant or planning to become pregnant
4. Participated in any other clinical trial in the past 30 day
5. Participated in any PepsiCo trial in the past 6 months
6. Physical injury that would prevent participation in exercise group

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Education plus metabolic testing

Classroom session with slides and videos. Exercise with shared exercise data.

other: Education only

Classroom session with slides and videos.

Interventions

Education

One 45 minute educational session on the role of carbohydrate in exercise

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 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. ]

Central Contacts and Locations

Central contacts

Locations

Gatorade Sports Science Institute at IMG Academy

Recruiting

Bradenton, Florida, United States, 34210

Contacts

Principal Investigator:

Kris Osterberg, PhD, RD

More Information

Sponsor

PepsiCo Global R&D

Last update posted

Feb 20, 2025

Last verified

Feb, 2025

Keywords

  • exercise performance
  • metabolic testing
  • education
  • carbohydrate
  • adolescent
  • female
  • athlete

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by PepsiCo Global R&D on 2025-02-20.