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Female AthletesNCT07883278

A Descriptive Analysis of the Physiological and Behavioral Profiles of Elite Female Athletes

An observational study of Female Athletes and Healthy Women, run by PepsiCo Global R&D at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

In May 2026, the Gatorade Brand launched the "Body of Science" (BoS), a multi-year research initiative aimed at closing the gender gap in sports science. While research is the heart of the BoS initiative, the platform also provides external engagement opportunities to connect with women. Read more about this study

Who is it for?
Ages 16 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Female Athletes, Healthy Women
How many people
50 participants
Where
1 siteUnited States
Study dates
Oct 2026to Jul 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Study population: Elite female athletes,16-45 years old.

Who may be able to join

  • 1.Elite female athletes aged between the ages of 16-45 years old. 2. Non-smoker 3. Willing to fast overnight (10 hours) prior to testing 4. Able to give verbal and written informed consent or assent for participation as well as obtain parental consent if <18 years of age.
  • 5. Must be fluent in English reading, writing, and speaking or have translator onsite.

Who cannot join

  • 1. Pregnant or planning to become pregnant 2. Participated in clinical trial within the last 30 days 3. Participated in PepsiCo study within the past 3 months 4. Incurred injury that would prevent participation in the exercise group

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • IMG Academy/GSSI Bradenton Gatorade Sports Science Institute

    Bradenton, Florida, 34210

Other trials in United States

About this study

In May 2026, the Gatorade Brand launched the "Body of Science" (BoS), a multi-year research initiative aimed at closing the gender gap in sports science. While research is the heart of the BoS initiative, the platform also provides external engagement opportunities to connect with women.

To help tell the story, the Gatorade Brand is interested in ways our current roster of female athletes can participate in the research. To support this request, we developed a battery of tests designed to provide descriptive information about elite female athletes from a variety of sports, including attributes to contribute to athletic performance but also everyday information that supports overall well-being.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Urine Specific Gravity

    au

    Measured: Day 1

  2. Fluid Balance

    % body mass change before and after exercise.

    Measured: Day 1

  3. Sweat Rate

    Participant will have sweat collection patches placed on specific sites (e.g., head, forearm, upper chest, scapula) during exercise activity to collect sweat sample.

    Measured: Day 1, during exercise

  4. Sweat Sodium

    Participant will have sweat collection patches placed on specific sites (e.g., head, forearm, upper chest, scapula) during exercise activity to collect sweat sample.

    Measured: Day 1, during exercise

  5. Female Athlete Hydration Insights Survey

    this survey aims to assess daily female athlete hydration habits

    Measured: Day 1

  6. Meaning of Hydration

    this survey aims to get an understanding of a person's perception and beliefs around hydration

    Measured: Day 1

  7. Managing Hydration

    this survey aims to assess a person's habits surrounding hydration.

    Measured: Day 1

  8. Low Energy Availability Questionnaire (LEAF-Q)

    Validated questionnaire that assesses injury, gastrointestinal symptoms, and menstrual function, score > 8 at risk for LEA

    Measured: Day 1

Secondary outcomes (25)
  1. Height

    cm

    Measured: Day 1

  2. Weight

    kg

    Measured: Day 1

  3. Menstrual Cycle Surveys

    Survey aims to collect participant symptoms in and around a menstrual cycle (i.e. mood, energy, overall feeling, etc.)

    Measured: Day 1

  4. Blood Omega-3

    mg/dL

    Measured: Day 1

  5. Blood vitamin D

    ng/mL

    Measured: Day 1

  6. Blood Sodium

    mmol/L

    Measured: Day 1

  7. Blood Potassium

    mmol/L

    Measured: Day 1

  8. Blood glucose

    mg/dL

    Measured: Day 1

  9. Blood Hct/Hib

    Ratio of % to g/dL, deviation from a ratio of 3.0 is abnormal

    Measured: Day 1

  10. Serum free triiodothyronine (T3)

    ng/dL

    Measured: Day 1

  11. Serum ferritin

    ng/mL

    Measured: Day 1

  12. Serum IGF-1

    ng/mL

    Measured: Day 1

  13. Body composition

    lean soft tissue vs fat mass measured by either BodPod or DXA

    Measured: Day 1

  14. Resting Metabolic Rate

    After 15 minute rest interval, participants will lie on table and remain as still as possible while breathing into a mask. The mask will collect expired gas for ~15-30 minutes to give a measure or baseline energy requirements for day-to-day activity.

    Measured: Day 1

  15. Fuel Profile

    Incremental exercise test (on treadmill or cycle ergometer) in which exercise intensity is progressively increased until participant chooses to stop. Participant will be encouraged to go as long as possible. During the test, participants will continuously breathe into a mask while exhaled gas is collected and measured and used to display subjective substrate metabolism markers (carb vs fat burn)

    Measured: Day 1

  16. VO2 Max

    Incremental exercise test in which exercise intensity is progressively increased until participants reach volitional fatigue. are no longer able to continue exercising. During the test, participants will continuously breathe into a mask while exhaled air is collected and measured to determine the maximal rate of oxygen used during exercise bout.

    Measured: Day 1

  17. Capillary lactate

    Collected every stage during a fuel profile/Vo2max test

    Measured: Day 1

  18. Force Plate

    participants will perform either a countermovement jump (CMJ) or an Isometric Mid-Thigh Pull (IMTP) as measure of power or strength output respectively. For CMJ, participants will stand with legs shoulder width apart on plates then will jump upward with max force to display power output. For IMTP, participants will stand with legs shoulder width apart on plates and will pull a stationary barbell upward as a measure of how much strength can be exerted on the bar. These maximal pulls will last 3-5 seconds.

    Measured: Day 1

  19. Isokinetic (Dynometer)

    Researchers will use a computer-controlled device to carry out flexion, extension, and rotation movements across the shoulder, elbow, hip, knee, and/or ankle joints to analyze muscle control, fatigue, and muscle strength. Participants will be asked to carry out contractions at a set pace, at maximal force, or as quickly as possible. Participants will be given 30 seconds rests between movement tests

    Measured: Day 1

  20. Neck Strength

    Participants will attach neck to strength device and testing will take place in the plane of interest (flexion, extension, lateral flexion, retraction/protraction). No visible movement will occur. Participants will old steady against resistance in order to generate force.

    Measured: Day 1

  21. Hand Grip (Dynometer)

    Participants will used a computer-controlled handgrip device to analyze handgrip fatigue and grip strength. Participants will perform 3 maximal handgrip contractions with 30 seconds separating each contraction. Participants may also perform maximal handgrip contraction and be timed to determine how long it takes to reach 70% of maximal force. Finally, participants may perform a series of submaximal contractions, squeezing for 3 seconds then resting for 3 seconds.

    Measured: Day 1

  22. Dynavision (D2)

    Participants will stand in front of D2 and complete preset protocol to measure cognition and reaction time. Participants will be required to press buttons as they light up and recite numbers as they appear on a screen, and score is recorded.

    Measured: Day 1

  23. Reflexion Edge

    Participants complete preset protocols to measure cognition and reaction time. Protocols vary from sport specific drills to testing hand-eye coordination, peripheral vision, reaction time, hand speed, etc

    Measured: Day 1

  24. Bone Mineral Density

    Measured via DXA scan

    Measured: Day 1

  25. Adverse Events

    Documented changes in health and symptoms as a safety measurement

    Measured: Through study completion, an average of 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionJun 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07883278
Sponsor's protocol ID
PEP-2607
Status last verified
Oct 2026
First submitted
13 Oct 2026
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Female Athletes and Healthy Women, run by PepsiCo Global R&D at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Urine Specific Gravity (time frame: Day 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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