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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
72
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.
GSSI Bradenton
Bradenton, Florida, United States
RECRUITINGGSSI Valhalla
Valhalla, New York, United States
RECRUITINGFluid Balance
calculated as change in nude body mass from baseline (%)
Time frame: Change from baseline, 4 hours
Fluid Balance
calculated as change in nude body mass from baseline (g)
Time frame: Change from baseline, 4 hours
Urine Mass
g
Time frame: Change from baseline, 4 hours
Urine Specific Gravity
au
Time frame: Change from baseline, 4 hours
Urine Osmolality
mosmol/kg
Time frame: Change from baseline, 4 hours
Fluid Retention
Percentage (%)
Time frame: Change from baseline, 4 hours
Free Water Clearance
ml/min
Time frame: Change from baseline, 4 hours
Whole blood sodium concentration
mmol/L
Time frame: Change from baseline, 4 hours
Whole blood potassium concentration
mmol/L
Time frame: Change from baseline, 4 hours
Whole blood glucose concentration
mg/dl
Time frame: Change from baseline, 4 hours
Whole blood hematocrit
Percentage (%)
Time frame: Change from baseline, 4 hours
Whole blood hemoglobin concentration
g/dl
Time frame: Change from baseline, 4 hours
Serum osmolality
mosmol/kg
Time frame: Change from baseline, 4 hours
Serum copeptin concentration
pmol/L
Time frame: Change from baseline, 4 hours
Serum estrogen
pg/mL
Time frame: Change from baseline, 4 hours
Serum progesterone
ng/mL
Time frame: Change from baseline, 4 hours
Serum follicle stimulating hormone (FSH)
pg/mL
Time frame: Change from baseline, 4 hours
Capillary follicle stimulating hormone (FSH)
MIU/mL
Time frame: At baseline, to determine menstruation status
Salivary Cortisol
ng/mL
Time frame: Change from baseline, 4 hours
Salivary Estradiol
pg/mL
Time frame: Change from baseline, 4 hours
Salivary Progesterone
pg/mL
Time frame: Change from baseline, 4 hours
Low energy availability Questionnaire (LEAF-Q)
Validated questionnaire that assesses injury, gastrointestinal symptoms, and menstrual function, score \> 8 at risk for LEA
Time frame: at screening to determine menstrual history
Menopause Rating Scale (MRS)
5-point likert scale assessing symptoms as none (0) to very severe (4), \> score mean more severe/greater number of symptoms
Time frame: at baseline to determine menopause symptoms
Feeling Scale (FS)
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
Gastrointestinal discomfort and headache (VAS)
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
Mental and physical energy and fatigue (VAS)
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
Blood Pressure
systolic/diastolic, mm/Hg
Time frame: Change from baseline, 4 hours
Heart Rate
Beats per minute (BPM)
Time frame: Change from baseline, 4 hours
Adverse Events
Documented changes in health and symptoms as a safety measurement
Time frame: Through study completion, an average of 4 weeks for pre- and peri-menopausal subjects and 2 weeks for post-menopausal subjects.
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