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.
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
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.
- Conditions
- Female Athletes, Healthy Women
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine Specific Gravity
au
Measured: Day 1
Fluid Balance
% body mass change before and after exercise.
Measured: Day 1
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
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
Female Athlete Hydration Insights Survey
this survey aims to assess daily female athlete hydration habits
Measured: Day 1
Meaning of Hydration
this survey aims to get an understanding of a person's perception and beliefs around hydration
Measured: Day 1
Managing Hydration
this survey aims to assess a person's habits surrounding hydration.
Measured: Day 1
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)
Height
cm
Measured: Day 1
Weight
kg
Measured: Day 1
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
Blood Omega-3
mg/dL
Measured: Day 1
Blood vitamin D
ng/mL
Measured: Day 1
Blood Sodium
mmol/L
Measured: Day 1
Blood Potassium
mmol/L
Measured: Day 1
Blood glucose
mg/dL
Measured: Day 1
Blood Hct/Hib
Ratio of % to g/dL, deviation from a ratio of 3.0 is abnormal
Measured: Day 1
Serum free triiodothyronine (T3)
ng/dL
Measured: Day 1
Serum ferritin
ng/mL
Measured: Day 1
Serum IGF-1
ng/mL
Measured: Day 1
Body composition
lean soft tissue vs fat mass measured by either BodPod or DXA
Measured: Day 1
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
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
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
Capillary lactate
Collected every stage during a fuel profile/Vo2max test
Measured: Day 1
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
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
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
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
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
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
Bone Mineral Density
Measured via DXA scan
Measured: Day 1
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.
- First posted20 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female AthletesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Descriptive Analysis of the Physiological and Behavioral Profiles of Elite Female Athletes
- ClinicalTrials.gov ID
- NCT07883278
- Acronym / sponsor ID
- PEP-2607
- Conditions
- Female Athletes, Healthy Women
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Elite female athletes,16-45 years old.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Urine Specific Gravity
Time frame: Day 1
au
Fluid Balance
Time frame: Day 1
% body mass change before and after exercise.
Sweat Rate
Time frame: Day 1, during exercise
Participant will have sweat collection patches placed on specific sites (e.g., head, forearm, upper chest, scapula) during exercise activity to collect sweat sample.
Sweat Sodium
Time frame: Day 1, during exercise
Participant will have sweat collection patches placed on specific sites (e.g., head, forearm, upper chest, scapula) during exercise activity to collect sweat sample.
Female Athlete Hydration Insights Survey
Time frame: Day 1
this survey aims to assess daily female athlete hydration habits
Meaning of Hydration
Time frame: Day 1
this survey aims to get an understanding of a person's perception and beliefs around hydration
Managing Hydration
Time frame: Day 1
this survey aims to assess a person's habits surrounding hydration.
Low Energy Availability Questionnaire (LEAF-Q)
Time frame: Day 1
Validated questionnaire that assesses injury, gastrointestinal symptoms, and menstrual function, score > 8 at risk for LEA
25 secondary outcomes
Height
Time frame: Day 1
Weight
Time frame: Day 1
Menstrual Cycle Surveys
Time frame: Day 1
Blood Omega-3
Time frame: Day 1
Blood vitamin D
Time frame: Day 1
Blood Sodium
Time frame: Day 1
Blood Potassium
Time frame: Day 1
Blood glucose
Time frame: Day 1
Blood Hct/Hib
Time frame: Day 1
Serum free triiodothyronine (T3)
Time frame: Day 1
Serum ferritin
Time frame: Day 1
Serum IGF-1
Time frame: Day 1
Body composition
Time frame: Day 1
Resting Metabolic Rate
Time frame: Day 1
Fuel Profile
Time frame: Day 1
VO2 Max
Time frame: Day 1
Capillary lactate
Time frame: Day 1
Force Plate
Time frame: Day 1
Isokinetic (Dynometer)
Time frame: Day 1
Neck Strength
Time frame: Day 1
Hand Grip (Dynometer)
Time frame: Day 1
Dynavision (D2)
Time frame: Day 1
Reflexion Edge
Time frame: Day 1
Bone Mineral Density
Time frame: Day 1
Adverse Events
Time frame: Through study completion, an average of 2 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.