Clinical trial NCT06837376: Effects of Metabolic Testing Data and Education on Attitudes and Beliefs Related to Carbohydrate Intake in Adolescent Female Athletes
Official title: Effects of Metabolic Testing Data and Education on Attitudes and Beliefs Related to Carbohydrate Intake in Adolescent Female Athletes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nutritional Deficiency
Keywords: exercise performance
metabolic testing
education
carbohydrate
adolescent
female
athlete
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2025-02-20
Enrollment: 60
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Education versus Education plus metabolic testing
timeFrame: 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:
measure: Education alone
timeFrame: 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.
Other outcomes:
Locations:
city: Bradenton
country: United States
facility: Gatorade Sports Science Institute at IMG Academy
state: Florida
Study officials:
affiliation: PepsiCo R&D Life Sciences, Sports Science
name: Kris Osterberg, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: