Hydration in women across life stages
Official title: Effect of Female Life Stage on Rehydration With Water vs. an Electrolyte Solution After Overnight Fast/Fluid Restriction
Run by PepsiCo Global R&D · NCT07653620 · Data updated 2026-11-12
This study tests how well water and electrolyte drinks rehydrate women at different life stages after overnight fasting and fluid restriction.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | Women only |
| Enrollment | 72 (estimated) |
| Sponsor | PepsiCo Global R&D Industry-sponsored |
| Locations | 2 sites (Bradenton, Florida and 1 other locations) |
| Status | Recruiting |
| Started | June 29, 2026 |
| Main results expected | November 2026 |
| Study ends | December 2026 |
| Registry record updated | September 21, 2026 |
| Trial ID | NCT07653620 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18-60 who are regularly physically active and fall into premenopausal, perimenopausal, or postmenopausal categories.
✕Probably not a fit
Individuals outside the specified life-stage ranges or with conditions that affect fluid balance may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial compares hydration responses to a placebo beverage versus an electrolyte beverage in healthy, recreationally active women across premenopausal, perimenopausal, and postmenopausal stages. Participants fast overnight and undergo a period of controlled fluid restriction before consuming the test drinks, with hydration markers measured to assess effectiveness. Locations include GSSI Bradenton in Florida and GSSI Valhalla in New York, sponsored by PepsiCo Global R&D. The goal is to understand whether female life stage influences rehydration needs and responses. No active disease focus is stated, and results could inform stage-specific hydration recommendations.
Why it matters
Potential benefit: If successful, the findings could lead to tailored hydration strategies for women at different life stages.
How similar studies have gone: Past research has explored hydration in general populations, but direct comparisons across all female life stages remain limited and are relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
* • 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)
o See appendix 13.8 for list of medications, drugs, and/or medical conditions that may impair cognitive functioning, alter physiological responses relevant to the study outcomes, or increase the risk associated with participation.
* 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 Criteria:
* • 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.
Where it's running
-
GSSI Bradenton
Bradenton, Florida, United States Recruiting -
GSSI Valhalla
Valhalla, New York, United States Recruiting
Study contacts
- Study coordinator: Samantha Goldenstein
- Email: GatoradeGSSIIMG@pepsico.com
- Phone: 847-707-3118
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.