DehydrationNCT07653620
Hydration & Female Life Stages
A study testing electrolyte beverage in people with Dehydration and Menstruation, run by PepsiCo Global R&D at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dehydration, Menstruation, Pre-menopause
- What is being tested?
- electrolyte beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Jun 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- • 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
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- 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
Who cannot join
- • 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
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
GSSI Bradenton
Bradenton, Florida, 34210
Samantha Goldenstein, 847-707-3118, GatoradeGSSIIMG@pepsico.com
- Recruiting
GSSI Valhalla
Valhalla, New York, 10595
Susan Kwiecien, 847-707-3118, GSSIresearchstaff@pepsico.com
About this study
Official title: Effect of Female Life Stage on Rehydration With Water vs. an Electrolyte Solution After Overnight Fast/Fluid Restriction
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
- Conditions
- Dehydration, Menstruation, Pre-menopause, Peri-menopausal Women, Post-menopausal Women, Hydration
- Being tested
- placebo beverage, electrolyte beverage
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placebo beverageOther
333 mL aliquots 3 times for a total of 1 L over a 30 min period. Time 0 begins post-dose.
electrolyte beverageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Beverage | Placebo comparator | Not described Receives: Other: placebo beverage |
| Electrolyte Beverage | Experimental | Not described Receives: Other: electrolyte beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid Balance
calculated as change in nude body mass from baseline (%)
Measured: Change from baseline, 4 hours
Secondary outcomes (28)
Fluid Balance
calculated as change in nude body mass from baseline (g)
Measured: Change from baseline, 4 hours
Urine Mass
g
Measured: Change from baseline, 4 hours
Urine Specific Gravity
au
Measured: Change from baseline, 4 hours
Urine Osmolality
mosmol/kg
Measured: Change from baseline, 4 hours
Fluid Retention
Percentage (%)
Measured: Change from baseline, 4 hours
Free Water Clearance
ml/min
Measured: Change from baseline, 4 hours
Whole blood sodium concentration
mmol/L
Measured: Change from baseline, 4 hours
Whole blood potassium concentration
mmol/L
Measured: Change from baseline, 4 hours
Whole blood glucose concentration
mg/dl
Measured: Change from baseline, 4 hours
Whole blood hematocrit
Percentage (%)
Measured: Change from baseline, 4 hours
Whole blood hemoglobin concentration
g/dl
Measured: Change from baseline, 4 hours
Serum osmolality
mosmol/kg
Measured: Change from baseline, 4 hours
Serum copeptin concentration
pmol/L
Measured: Change from baseline, 4 hours
Serum estrogen
pg/mL
Measured: Change from baseline, 4 hours
Serum progesterone
ng/mL
Measured: Change from baseline, 4 hours
Serum follicle stimulating hormone (FSH)
pg/mL
Measured: Change from baseline, 4 hours
Capillary follicle stimulating hormone (FSH)
MIU/mL
Measured: At baseline, to determine menstruation status
Salivary Cortisol
ng/mL
Measured: Change from baseline, 4 hours
Salivary Estradiol
pg/mL
Measured: Change from baseline, 4 hours
Salivary Progesterone
pg/mL
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: change from baseline, 4 hours
Blood Pressure
systolic/diastolic, mm/Hg
Measured: Change from baseline, 4 hours
Heart Rate
Beats per minute (BPM)
Measured: Change from baseline, 4 hours
Adverse Events
Documented changes in health and symptoms as a safety measurement
Measured: Through study completion, an average of 4 weeks for pre- and peri-menopausal subjects and 2 weeks for post-menopausal subjects.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start29 Jun 2026
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DehydrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653620
- Sponsor's protocol ID
- PEP-2604
- Status last verified
- Sep 2026
- First submitted
- 12 Jun 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Female Life Stage on Rehydration With Water vs. an Electrolyte Solution After Overnight Fast/Fluid Restriction
- ClinicalTrials.gov ID
- NCT07653620
- Acronym / sponsor ID
- PEP-2604
- Conditions
- Dehydration, Menstruation, Pre-menopause, Peri-menopausal Women, Post-menopausal Women, Hydration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Beverage | Placebo comparator | Other: placebo beverage |
| Electrolyte Beverage | Experimental | Other: electrolyte beverage |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (35 listed)
- • Sex assigned female at birth.
- 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.
Key exclusion criteria (9 listed)
- • Currently pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placebo beverage333 mL aliquots 3 times for a total of 1 L over a 30 min period. Time 0 begins post-dose. | Other | Placebo Beverage |
| electrolyte beverage333 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. | Other | Electrolyte Beverage |
Primary outcome
Fluid Balance
Time frame: Change from baseline, 4 hours
calculated as change in nude body mass from baseline (%)
28 secondary outcomes
Fluid Balance
Time frame: Change from baseline, 4 hours
Urine Mass
Time frame: Change from baseline, 4 hours
Urine Specific Gravity
Time frame: Change from baseline, 4 hours
Urine Osmolality
Time frame: Change from baseline, 4 hours
Fluid Retention
Time frame: Change from baseline, 4 hours
Free Water Clearance
Time frame: Change from baseline, 4 hours
Whole blood sodium concentration
Time frame: Change from baseline, 4 hours
Whole blood potassium concentration
Time frame: Change from baseline, 4 hours
Whole blood glucose concentration
Time frame: Change from baseline, 4 hours
Whole blood hematocrit
Time frame: Change from baseline, 4 hours
Whole blood hemoglobin concentration
Time frame: Change from baseline, 4 hours
Serum osmolality
Time frame: Change from baseline, 4 hours
Serum copeptin concentration
Time frame: Change from baseline, 4 hours
Serum estrogen
Time frame: Change from baseline, 4 hours
Serum progesterone
Time frame: Change from baseline, 4 hours
Serum follicle stimulating hormone (FSH)
Time frame: Change from baseline, 4 hours
Capillary follicle stimulating hormone (FSH)
Time frame: At baseline, to determine menstruation status
Salivary Cortisol
Time frame: Change from baseline, 4 hours
Salivary Estradiol
Time frame: Change from baseline, 4 hours
Salivary Progesterone
Time frame: Change from baseline, 4 hours
Low energy availability Questionnaire (LEAF-Q)
Time frame: at screening to determine menstrual history
Menopause Rating Scale (MRS)
Time frame: at baseline to determine menopause symptoms
Feeling Scale (FS)
Time frame: change from baseline, 4 hours
Gastrointestinal discomfort and headache (VAS)
Time frame: change from baseline, 4 hours
Mental and physical energy and fatigue (VAS)
Time frame: change from baseline, 4 hours
Blood Pressure
Time frame: Change from baseline, 4 hours
Heart Rate
Time frame: Change from baseline, 4 hours
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrolyte beverage in people with Dehydration and Menstruation, run by PepsiCo Global R&D at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 35 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samantha Goldenstein (847-707-3118, GatoradeGSSIIMG@pepsico.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluid Balance (time frame: Change from baseline, 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.