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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Beverage | Placebo Comparator |
| |
| Electrolyte Beverage | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo beverage | Other | 333 mL aliquots 3 times for a total of 1 L over a 30 min period. Time 0 begins post-dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fluid Balance | calculated as change in nude body mass from baseline (%) | Change from baseline, 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Fluid Balance | calculated as change in nude body mass from baseline (g) | Change from baseline, 4 hours |
| Urine Mass | g | Change from baseline, 4 hours |
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Inclusion Criteria:
• 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)
Age 18-60 years, within the following life stage ranges specified below:
Premenopausal:
Perimenopausal:
Postmenopausal:
Healthy, with no known renal, cardiovascular, metabolic, or endocrine disorders that affect hydration or fluid regulation.
Not currently taking medications known to influence fluid balance (e.g., diuretics, laxatives, weight loss agents, or other relevant medications) or the hypothalamus-pituitary-gonadal axis (e.g., ovulation induction agents, gonadotropins, IVF stimulation medications, or other relevant medications)
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.
Not receive any fertility treatments within the past 6 months
No hormonal contraceptives use within the past 6 months
If using a paraguard copper IUD, it must be inserted for ≥ 3 months (if applicable)
BMI ≤ 30 kg/m²
Are not participating in a weight loss program
Are not allergic to adhesives, stevia, and strawberry lime flavoring
Willing to avoid strenuous activity and alcohol consumption 24 hours prior to all visits
Willing to fast overnight (~12 hours) prior to the medical screening
For visit 2 and 4:
For visits 3 and 5:
Willing to restrict all fluids (~18 hours)
Willing to limit fluid consumption to 1 L the morning/afternoon prior to the start of the fluid restriction
Willing to restrict food (~12 hours) the day prior to each visit Willing to eat a consistent diet the day prior
Fluent in English (able to read, understand, and provide informed consent).
Willing and able to provide informed consent to participate in the study and comply with all study procedures and scheduled visits
Exclusion Criteria:
• Currently pregnant or breastfeeding
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samantha Goldenstein | Contact | 847-707-3118 | GatoradeGSSIIMG@pepsico.com | |
| Susan Kwiecien | Contact | 847-707-3118 | GSSIresearchstaff@pepsico.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSSI Bradenton | Recruiting | Bradenton | Florida | 34210 | United States |
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| ID | Term |
|---|---|
| D003681 | Dehydration |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
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| electrolyte beverage | Other | 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. |
|
| Urine Specific Gravity | au | Change from baseline, 4 hours |
| Urine Osmolality | mosmol/kg | Change from baseline, 4 hours |
| Fluid Retention | Percentage (%) | Change from baseline, 4 hours |
| Free Water Clearance | ml/min | Change from baseline, 4 hours |
| Whole blood sodium concentration | mmol/L | Change from baseline, 4 hours |
| Whole blood potassium concentration | mmol/L | Change from baseline, 4 hours |
| Whole blood glucose concentration | mg/dl | Change from baseline, 4 hours |
| Whole blood hematocrit | Percentage (%) | Change from baseline, 4 hours |
| Whole blood hemoglobin concentration | g/dl | Change from baseline, 4 hours |
| Serum osmolality | mosmol/kg | Change from baseline, 4 hours |
| Serum copeptin concentration | pmol/L | Change from baseline, 4 hours |
| Serum estrogen | pg/mL | Change from baseline, 4 hours |
| Serum progesterone | ng/mL | Change from baseline, 4 hours |
| Serum follicle stimulating hormone (FSH) | pg/mL | Change from baseline, 4 hours |
| Capillary follicle stimulating hormone (FSH) | MIU/mL | At baseline, to determine menstruation status |
| Salivary Cortisol | ng/mL | Change from baseline, 4 hours |
| Salivary Estradiol | pg/mL | Change from baseline, 4 hours |
| Salivary Progesterone | pg/mL | 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 | 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 | 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 | 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 | 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 | change from baseline, 4 hours |
| Blood Pressure | systolic/diastolic, mm/Hg | Change from baseline, 4 hours |
| Heart Rate | Beats per minute (BPM) | Change from baseline, 4 hours |
| Adverse Events | Documented changes in health and symptoms as a safety measurement | Through study completion, an average of 4 weeks for pre- and peri-menopausal subjects and 2 weeks for post-menopausal subjects. |
| GSSI Valhalla | Recruiting | Valhalla | New York | 10595 | United States |
|
| D013568 | Pathological Conditions, Signs and Symptoms |