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Study tests if menopause changes how women rehydrate

NCT ID NCT07653620

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 21, 2026 · Updated 1 time

Summary

This study looks at how women in three life stages—premenopausal, perimenopausal, and postmenopausal—rehydrate after an overnight fast and fluid restriction. Participants will drink either plain water or an electrolyte beverage. Researchers will measure fluid balance and other markers to see if hormonal changes affect hydration needs.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
electrolyte beverage
What this could lead to
If successful, this study could help tailor hydration advice for women at different life stages.
What could go wrong
This is a small, early-stage observational study (72 participants) with no disease treatment goal. Results may not apply broadly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 72 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Dehydration

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    2 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • GSSI Bradenton

    RECRUITING

    Bradenton, Florida, 34210, United States

  • GSSI Valhalla

    RECRUITING

    Valhalla, New York, 10595, United States

    Contact Email: •••••@•••••

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