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NCT Number: NCT06837376

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

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.

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Key information

Conditions

Nutritional Deficiency Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

13 year–19 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gatorade Sports Science Institute at IMG Academy

Bradenton, Florida, 34210, United States

Location status: Recruiting

Location contact

Kris Osterberg, PhD, RD

CONTACT

[email protected]

847-707-3118

Kris Osterberg, PhD, RD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

Education

Other

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

Metabolic Testing (Exercise) with shared interpreted results

Other

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 outcomes

  1. 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.

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Justina Bonsignore

CONTACT

[email protected]

Kris Osterberg, PhD, RD

CONTACT

[email protected]

(847)707-3118

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2025
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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