Hydration for Female Life Stages
What You Need to Know Before You Apply
What is the purpose of this trial?
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
Are You a Good Fit for This Trial?
This trial is for healthy women aged 18-60, assigned female at birth, who are premenopausal (18-35), perimenopausal (35-55), or postmenopausal (45-60). Participants must exercise regularly, have stable menstrual patterns based on their life stage, not be pregnant or breastfeeding, and have no major health issues affecting hydration.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo rehydration with water and electrolyte solution after overnight fast and fluid restriction
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Trial Overview
The study compares how women in different life stages rehydrate after fasting and fluid restriction by giving them either an electrolyte drink or a placebo beverage. The goal is to see if hormone changes across these stages affect the body's ability to regain fluids.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
PepsiCo Global R&D
Lead Sponsor
Ramon Laguarta
PepsiCo Global R&D
Chief Executive Officer since 2018
MBA from ESADE Business School
Mark Kirkham
PepsiCo Global R&D
Chief Marketing Officer
Bachelor's degree in Business Administration from Trinity College Dublin
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