Hydration & Female Life Stages

NCT07653620 | Recruiting

• 1 other identifier: PEP-2604
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

Female life stages including premenopausal, perimenopausal, postmenopausal, are characterized by changing concentrations and patterns of hormones. The premenopause stage represents the reproductive years with normal menstrual cycles lasting between 21-35 days. The perimenopause stage is the beginning of the menopause transition and can last up to 10 years. During this transition, menstrual cycles become longer and irregular in length (7 days or longer). After 12 consecutive months with no period, the transition is complete into the postmenopause stage. Hormones that change across the lifespan are known to influence systems that regulate thirst, fluid balance, and sodium balance. Yet, fluid balance across life stages remains poorly understood, with no direct comparisons across all three life stages. The purpose of this study is to evaluate the effect of female life stage on rehydration with water and electrolyte solution after overnight fast and fluid restriction

Conditions

Dehydration; Menstruation; Pre-menopause; Peri-menopausal Women; Post-menopausal Women; Hydration

Outcome Measures

Primary Outcomes (1)

• Fluid Balance

  calculated as change in nude body mass from baseline (%)

  Change from baseline, 4 hours

Secondary Outcomes (28)

• Fluid Balance

  Change from baseline, 4 hours

• Urine Mass

  Change from baseline, 4 hours

• Urine Specific Gravity

  Change from baseline, 4 hours

• Urine Osmolality

  Change from baseline, 4 hours

• Fluid Retention

  Change from baseline, 4 hours

Study Arms (2)

Placebo Beverage

PLACEBO COMPARATOR

Other: placebo beverage

Electrolyte Beverage

EXPERIMENTAL

Other: electrolyte beverage

Interventions

placebo beverage OTHER

333 mL aliquots 3 times for a total of 1 L over a 30 min period. Time 0 begins post-dose.

Placebo Beverage

electrolyte beverage OTHER

333 mL aliquots 3 times for a total of 1 L over a 30 min period. Time 0 begins post-dose. Beverage matched to placebo for color and flavor.

Electrolyte Beverage

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• PepsiCo Global R&D: lead

Study Sites (2)

GSSI Bradenton

Bradenton, Florida, 34210, United States

RECRUITING

GSSI Valhalla

Valhalla, New York, 10595, United States

RECRUITING

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Samantha Goldenstein

CONTACT

847-707-3118; GatoradeGSSIIMG@pepsico.com

Susan Kwiecien

CONTACT

847-707-3118; GSSIresearchstaff@pepsico.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)