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Hydration & Female Life Stages

12 giugno 2026 aggiornato da: PepsiCo Global R&D

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

Panoramica dello studio

Tipo di studio

Interventistico

Iscrizione (Stimato)

72

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

    • Florida
      • Bradenton, Florida, Stati Uniti, 34210
    • New York
      • Valhalla, New York, Stati Uniti, 10595

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Bevanda placebo
333 mL aliquots 3 times for a total of 1 L over a 30 min period. Time 0 begins post-dose.
Sperimentale: Electrolyte Beverage
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Fluid Balance
Lasso di tempo: Change from baseline, 4 hours
calculated as change in nude body mass from baseline (%)
Change from baseline, 4 hours

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Fluid Balance
Lasso di tempo: Change from baseline, 4 hours
calculated as change in nude body mass from baseline (g)
Change from baseline, 4 hours
Urine Mass
Lasso di tempo: Change from baseline, 4 hours
g
Change from baseline, 4 hours
Urine Specific Gravity
Lasso di tempo: Change from baseline, 4 hours
au
Change from baseline, 4 hours
Urine Osmolality
Lasso di tempo: Change from baseline, 4 hours
mosmol/kg
Change from baseline, 4 hours
Fluid Retention
Lasso di tempo: Change from baseline, 4 hours
Percentage (%)
Change from baseline, 4 hours
Free Water Clearance
Lasso di tempo: Change from baseline, 4 hours
ml/min
Change from baseline, 4 hours
Whole blood sodium concentration
Lasso di tempo: Change from baseline, 4 hours
mmol/L
Change from baseline, 4 hours
Whole blood potassium concentration
Lasso di tempo: Change from baseline, 4 hours
mmol/L
Change from baseline, 4 hours
Whole blood glucose concentration
Lasso di tempo: Change from baseline, 4 hours
mg/dl
Change from baseline, 4 hours
Whole blood hematocrit
Lasso di tempo: Change from baseline, 4 hours
Percentage (%)
Change from baseline, 4 hours
Whole blood hemoglobin concentration
Lasso di tempo: Change from baseline, 4 hours
g/dl
Change from baseline, 4 hours
Serum osmolality
Lasso di tempo: Change from baseline, 4 hours
mosmol/kg
Change from baseline, 4 hours
Serum copeptin concentration
Lasso di tempo: Change from baseline, 4 hours
pmol/L
Change from baseline, 4 hours
Serum estrogen
Lasso di tempo: Change from baseline, 4 hours
pg/mL
Change from baseline, 4 hours
Serum progesterone
Lasso di tempo: Change from baseline, 4 hours
ng/mL
Change from baseline, 4 hours
Serum follicle stimulating hormone (FSH)
Lasso di tempo: Change from baseline, 4 hours
pg/mL
Change from baseline, 4 hours
Capillary follicle stimulating hormone (FSH)
Lasso di tempo: At baseline, to determine menstruation status
MIU/mL
At baseline, to determine menstruation status
Salivary Cortisol
Lasso di tempo: Change from baseline, 4 hours
ng/mL
Change from baseline, 4 hours
Salivary Estradiol
Lasso di tempo: Change from baseline, 4 hours
pg/mL
Change from baseline, 4 hours
Salivary Progesterone
Lasso di tempo: Change from baseline, 4 hours
pg/mL
Change from baseline, 4 hours
Low energy availability Questionnaire (LEAF-Q)
Lasso di tempo: at screening to determine menstrual history
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)
Lasso di tempo: 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
at baseline to determine menopause symptoms
Feeling Scale (FS)
Lasso di tempo: 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
change from baseline, 4 hours
Gastrointestinal discomfort and headache (VAS)
Lasso di tempo: change from baseline, 4 hours
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)
Lasso di tempo: change from baseline, 4 hours
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
Lasso di tempo: Change from baseline, 4 hours
systolic/diastolic, mm/Hg
Change from baseline, 4 hours
Heart Rate
Lasso di tempo: Change from baseline, 4 hours
Beats per minute (BPM)
Change from baseline, 4 hours
Adverse Events
Lasso di tempo: 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
Through study completion, an average of 4 weeks for pre- and peri-menopausal subjects and 2 weeks for post-menopausal subjects.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 novembre 2026

Completamento dello studio (Stimato)

1 dicembre 2026

Date di iscrizione allo studio

Primo inviato

12 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

12 giugno 2026

Primo Inserito (Effettivo)

17 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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