Placebo beverage
Other333 mL aliquots 3 times for a total of 1 L over a 30 min period. Time 0 begins post-dose.
NCT Number: NCT07653620
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
Interested in participating?
Request Info18 year–60 year
Female
Interventional
Not applicable
GSSI Bradenton, Bradenton, Florida, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
o See appendix 13.8 for list of medications, drugs, and/or medical conditions that may impair cognitive functioning, alter physiological responses relevant to the study outcomes, or increase the risk associated with participation.
Exclusion criteria
333 mL aliquots 3 times for a total of 1 L over a 30 min period. Time 0 begins post-dose.
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.
Time frame: Change from baseline, 4 hours
calculated as change in nude body mass from baseline (%)
Time frame: Change from baseline, 4 hours
calculated as change in nude body mass from baseline (g)
Time frame: Change from baseline, 4 hours
g
Time frame: Change from baseline, 4 hours
au
Time frame: Change from baseline, 4 hours
mosmol/kg
Time frame: Change from baseline, 4 hours
Percentage (%)
Time frame: Change from baseline, 4 hours
ml/min
Time frame: Change from baseline, 4 hours
mmol/L
Time frame: Change from baseline, 4 hours
mmol/L
Time frame: Change from baseline, 4 hours
mg/dl
Time frame: Change from baseline, 4 hours
Percentage (%)
Time frame: Change from baseline, 4 hours
g/dl
Time frame: Change from baseline, 4 hours
mosmol/kg
Time frame: Change from baseline, 4 hours
pmol/L
Time frame: Change from baseline, 4 hours
pg/mL
Time frame: Change from baseline, 4 hours
ng/mL
Time frame: Change from baseline, 4 hours
pg/mL
Time frame: At baseline, to determine menstruation status
MIU/mL
Time frame: Change from baseline, 4 hours
ng/mL
Time frame: Change from baseline, 4 hours
pg/mL
Time frame: Change from baseline, 4 hours
pg/mL
Time frame: at screening to determine menstrual history
Validated questionnaire that assesses injury, gastrointestinal symptoms, and menstrual function, score > 8 at risk for LEA
Time frame: at baseline to determine menopause symptoms
5-point likert scale assessing symptoms as none (0) to very severe (4), > score mean more severe/greater number of symptoms
Time frame: change from baseline, 4 hours
11-point scale assessing changes in mood ranging from very good (5) to very bad (-5), positive score is associated with positive affect
Time frame: change from baseline, 4 hours
100-pt visual analog scale anchored from none (0) to severe (100), > score is associated with increased symptoms
Time frame: change from baseline, 4 hours
100-pt visual analog scale anchored from none (0) to severe (100), > score is associated with stronger feelings
Time frame: Change from baseline, 4 hours
systolic/diastolic, mm/Hg
Time frame: Change from baseline, 4 hours
Beats per minute (BPM)
Time frame: Through study completion, an average of 4 weeks for pre- and peri-menopausal subjects and 2 weeks for post-menopausal subjects.
Documented changes in health and symptoms as a safety measurement
Contact information is provided by the study sponsor or research team.
Samantha Goldenstein
CONTACT
Susan Kwiecien
CONTACT
PepsiCo Global R&D
Industry
Effect of Female Life Stage on Rehydration With Water vs. an Electrolyte Solution After Overnight Fast/Fluid Restriction
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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