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

NCT06837376 | Recruiting

• 1 other identifier: PEP-2408
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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.

Study Arms (2)

Education plus metabolic testing

OTHER

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

Other: Education; Other: Metabolic Testing (Exercise) with shared interpreted results

Education only

OTHER

Classroom session with slides and videos.

Other: Education

Interventions

Education OTHER

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

Education only; Education plus metabolic testing

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

Education plus metabolic testing

Eligibility Criteria

• Age: 13 Years - 19 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PepsiCo Global R&D: lead

Study Sites (1)

Gatorade Sports Science Institute at IMG Academy

Bradenton, Florida, 34210, United States

RECRUITING

MeSH Terms

Conditions

Malnutrition

Interventions

Educational Status; Exercise

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kris Osterberg, PhD, RD

  PepsiCo R&D Life Sciences, Sports Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kris Osterberg, PhD, RD

CONTACT

(847)707-3118; kris.osterberg@pepsico.com

Justina Bonsignore

CONTACT

Justina.Bonsignore@pepsico.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 20, 2025
• Study Start: February 5, 2025
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)