Hydration & Female Life Stages

Part of paid clinical trials in Bradenton, Florida.

Sponsor
PepsiCo Global R&D
Study ID
NCT07653620
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Nov 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Placebo Comparator: Placebo Beverage
  • Experimental: Electrolyte Beverage

Primary Outcome Measure

Fluid Balance [ Time Frame: Change from baseline, 4 hours ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
GSSI BradentonBradentonFlorida34210
Samantha Goldenstein
[email protected]
847-707-3118
GSSI ValhallaValhallaNew York10595
Susan Kwiecien
[email protected]
847-707-3118

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