NCT07653620
Hydration & Female Life Stages
Recruiting
NAAges 18–60InterventionalPepsiCo Global R&D
~72 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:placebo beverageelectrolyte beverage
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fluid Balance
Measured over Change from baseline, 4 hours
Conditions
Where it's being run
2 sites across 2 statesFlorida1
New York1
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
• Sex assigned female at birth.
Recreationally active (engaged in light to moderate-intensity, intermittent, or steady-state exercise at least 3 days per week for at least 30 min at a time)
Age 18-60 years, within the following life stage ranges specified below:
Premenopausal:
18-35 years
Self-report regular spontaneous menstrual cycle length (21-35 days) for the past 2 menstrual cycles
Menstrual cycle length \< 7 days variation in consecutive cycles
Perimenopausal:
Perimenopause: 35-55 years
If tracking cycles: self reported cycle irregularity (≥7 day difference from usual cycle length) for the past 2 menstrual cycles, not due to known pathology
If not tracking cycles: clinician diagnosis
Postmenopausal:
Postmenopause: 45-60 years
If tracking cycles: ≥12 consecutive months of spontaneous amenorrhea not due to pregnancy, lactation, or pathology
If not tracking cycles: clinician diagnosis
Healthy, with no known renal, cardiovascular, metabolic, or endocrine disorders that affect hydration or fluid regulation.
Not currently taking medications known to influence fluid balance (e.g., diuretics, laxatives, weight loss agents, or other relevant medications) or the hypothalamus-pituitary-gonadal axis (e.g., ovulation induction agents, gonadotropins, IVF stimulation medications, or other relevant medications)
Not receive any fertility treatments within the past 6 months
No hormonal contraceptives use within the past 6 months
If using a paraguard copper IUD, it must be inserted for ≥ 3 months (if applicable)
BMI ≤ 30 kg/m²
Are not participating in a weight loss program
Are not allergic to adhesives, stevia, and strawberry lime flavoring
Willing to avoid strenuous activity and alcohol consumption 24 hours prior to all visits
Willing to fast overnight (\~12 hours) prior to the medical screening
For visit 2 and 4:
Willing to fast overnight (\~12 hours)
Willing to consume a minimum of 2.7 L of water 24 hours prior to visits 2 and 4, then 500 mL 2 hours before the start of the visits 2 and 4
For visits 3 and 5:
Willing to restrict all fluids (\~18 hours)
Willing to limit fluid consumption to 1 L the morning/afternoon prior to the start of the fluid restriction
Willing to restrict food (\~12 hours) the day prior to each visit Willing to eat a consistent diet the day prior
Fluent in English (able to read, understand, and provide informed consent).
Willing and able to provide informed consent to participate in the study and comply with all study procedures and scheduled visits
Exclusion
• Currently pregnant or breastfeeding
\< 6 months since giving birth (even if experiencing 2 regular menstrual cycles in a row)
Smoking within the last 5 years
History of adverse events (e.g., fainting) with blood draws
Participants with large amount of internal metal (e.g., spinal rod) will be excluded from the DXA scan only (Brandenton)
Participant has participated in a clinical trial within the past 30 days
Participant has participated in any PepsiCo trial within past 3 months
Participant has a condition or is taking medication that the investigator believes would interfere with his/her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the person at undue risk
Participant is employed by, or has a parent, guardian, or other immediate family member employed by a company that manufactures any products that compete with any Gatorade product. If participant is unsure if a company would be considered a competitor to Gatorade, they will be asked to please let the study investigator know the name of the other company and the nature of their relationship to that company before they sign the informed consent.
What this trial measures
- Fluid BalanceChange from baseline, 4 hours
calculated as change in nude body mass from baseline (%)