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NCT Number: NCT07653620

Hydration & Female Life Stages

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

Recruiting

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

GSSI Bradenton, Bradenton, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • 18-35 years
  • Self-report regular spontaneous menstrual cycle length (21-35 days) for the past 2 menstrual cycles
  • Menstrual cycle length < 7 days variation in consecutive cycles
  • Perimenopausal:
  • Perimenopause: 35-55 years
  • If tracking cycles: self reported cycle irregularity (≥7 day difference from usual cycle length) for the past 2 menstrual cycles, not due to known pathology
  • If not tracking cycles: clinician diagnosis
  • Postmenopausal:
  • Postmenopause: 45-60 years
  • If tracking cycles: ≥12 consecutive months of spontaneous amenorrhea not due to pregnancy, lactation, or pathology
  • If not tracking cycles: clinician diagnosis
  • 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:
  • Willing to fast overnight (~12 hours)
  • Willing to consume a minimum of 2.7 L of water 24 hours prior to visits 2 and 4, then 500 mL 2 hours before the start of the visits 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
  • < 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
  • Participants with large amount of internal metal (e.g., spinal rod) will be excluded from the DXA scan only (Brandenton)
  • Participant has participated in a clinical trial within the past 30 days
  • Participant has participated in any PepsiCo trial within past 3 months
  • Participant has a condition or is taking medication that the investigator believes would interfere with his/her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the person at undue risk
  • Participant is employed by, or has a parent, guardian, or other immediate family member employed by a company that manufactures any products that compete with any Gatorade product. If participant is unsure if a company would be considered a competitor to Gatorade, they will be asked to please let the study investigator know the name of the other company and the nature of their relationship to that company before they sign the informed consent.

Treatment and study plan

Placebo beverage

Other

333 mL aliquots 3 times for a total of 1 L over a 30 min period. Time 0 begins post-dose.

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.

Primary outcomes

  1. Fluid Balance

    Time frame: Change from baseline, 4 hours

    calculated as change in nude body mass from baseline (%)

Secondary outcomes

  1. Fluid Balance

    Time frame: Change from baseline, 4 hours

    calculated as change in nude body mass from baseline (g)

  2. Urine Mass

    Time frame: Change from baseline, 4 hours

    g

  3. Urine Specific Gravity

    Time frame: Change from baseline, 4 hours

    au

  4. Urine Osmolality

    Time frame: Change from baseline, 4 hours

    mosmol/kg

  5. Fluid Retention

    Time frame: Change from baseline, 4 hours

    Percentage (%)

  6. Free Water Clearance

    Time frame: Change from baseline, 4 hours

    ml/min

  7. Whole blood sodium concentration

    Time frame: Change from baseline, 4 hours

    mmol/L

  8. Whole blood potassium concentration

    Time frame: Change from baseline, 4 hours

    mmol/L

  9. Whole blood glucose concentration

    Time frame: Change from baseline, 4 hours

    mg/dl

  10. Whole blood hematocrit

    Time frame: Change from baseline, 4 hours

    Percentage (%)

  11. Whole blood hemoglobin concentration

    Time frame: Change from baseline, 4 hours

    g/dl

  12. Serum osmolality

    Time frame: Change from baseline, 4 hours

    mosmol/kg

  13. Serum copeptin concentration

    Time frame: Change from baseline, 4 hours

    pmol/L

  14. Serum estrogen

    Time frame: Change from baseline, 4 hours

    pg/mL

  15. Serum progesterone

    Time frame: Change from baseline, 4 hours

    ng/mL

  16. Serum follicle stimulating hormone (FSH)

    Time frame: Change from baseline, 4 hours

    pg/mL

  17. Capillary follicle stimulating hormone (FSH)

    Time frame: At baseline, to determine menstruation status

    MIU/mL

  18. Salivary Cortisol

    Time frame: Change from baseline, 4 hours

    ng/mL

  19. Salivary Estradiol

    Time frame: Change from baseline, 4 hours

    pg/mL

  20. Salivary Progesterone

    Time frame: Change from baseline, 4 hours

    pg/mL

  21. Low energy availability Questionnaire (LEAF-Q)

    Time frame: at screening to determine menstrual history

    Validated questionnaire that assesses injury, gastrointestinal symptoms, and menstrual function, score > 8 at risk for LEA

  22. Menopause Rating Scale (MRS)

    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

  23. Feeling Scale (FS)

    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

  24. Gastrointestinal discomfort and headache (VAS)

    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

  25. Mental and physical energy and fatigue (VAS)

    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

  26. Blood Pressure

    Time frame: Change from baseline, 4 hours

    systolic/diastolic, mm/Hg

  27. Heart Rate

    Time frame: Change from baseline, 4 hours

    Beats per minute (BPM)

  28. Adverse Events

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Samantha Goldenstein

CONTACT

[email protected]

847-707-3118

Susan Kwiecien

CONTACT

[email protected]

847-707-3118

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Registry information

Official study title

Effect of Female Life Stage on Rehydration With Water vs. an Electrolyte Solution After Overnight Fast/Fluid Restriction

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

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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