Effects of Metabolic Testing Data and Education on Attitudes and Beliefs Related to Carbohydrate Intake in Adolescent Female Athletes

February 14, 2025 updated by: PepsiCo Global R&D

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Bradenton, Florida, United States, 34210
        • Recruiting
        • Gatorade Sports Science Institute at IMG Academy
        • Contact:
        • Principal Investigator:
          • Kris Osterberg, PhD, RD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Education plus metabolic testing
Classroom session with slides and videos. Exercise with shared exercise data.
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
Other: Education only
Classroom session with slides and videos.
Other: Education
One 45 minute educational session on the role of carbohydrate in exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within the education only group
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PepsiCo Global R&D

Investigators

  • Principal Investigator: Kris Osterberg, PhD, RD, PepsiCo R&D Life Sciences, Sports Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2025

Primary Completion (Estimated)

May 15, 2025

Study Completion (Estimated)

May 15, 2025

Study Registration Dates

First Submitted

February 14, 2025

First Submitted That Met QC Criteria

February 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEP-2408

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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