72 Participants NeededMy employer runs this trial

Hydration for Female Life Stages

Recruiting at 1 trial location
SG
SK
Overseen BySusan Kwiecien

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

Recreationally active with light to moderate-intensity exercise at least 3 days per week for at least 30 minutes each time
I was assigned female at birth.
Willing to fast overnight (~12 hours) prior to medical screening
See 17 more

Exclusion Criteria

Participation in any PepsiCo trial within past 3 months
Large amount of internal metal excluding from DXA scan only
Participation in any clinical trial within past 30 days
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Treatment

Participants undergo rehydration with water and electrolyte solution after overnight fast and fluid restriction

4 hours
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks
1-2 visits (in-person)

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

Group I: Electrolyte BeverageExperimental Treatment1 Intervention
Group II: Placebo BeveragePlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

PepsiCo Global R&D

Lead Sponsor

Trials
99
Recruited
13,600+

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