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

PepsiCo

Status: Enrolling

Conditions: Nutritional Deficiency

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06837376

PEP-2408

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 13 to 19 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Education plus metabolic testing

Other group

Description:

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

Treatment:

Other: Metabolic Testing (Exercise) with shared interpreted results

Other: Education

Education only

Other group

Description:

Classroom session with slides and videos.

Treatment:

Other: Education