Hydration & Female Life Stages
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorPepsiCo Global R&D
About 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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
• 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)
18-35 years
Self-report regular spontaneous menstrual cycle length (21-35 days) for the past 2 menstrual cycles
Disqualifiers
• 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
Trial design
Design model
Crossover
Treatments tested in this trial
placebo beverage
Other intervention333 mL aliquots 3 times for a total of 1 L over a 30 min period. Time 0 begins post-dose.
electrolyte beverage
Other intervention333 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.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Placebo BeveragePlacebo comparator 1 intervention
Group B: Electrolyte BeverageExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Fluid Balance
calculated as change in nude body mass from baseline (%)
Time frame
Change from baseline, 4 hoursSecondary outcomes
1
Fluid Balance
calculated as change in nude body mass from baseline (g)
Time frame
Change from baseline, 4 hours2
Urine Mass
g
Time frame
Change from baseline, 4 hours3
Urine Specific Gravity
au
Time frame
Change from baseline, 4 hours4
Urine Osmolality
mosmol/kg
Time frame
Change from baseline, 4 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov