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Hydration & Female Life Stages

12 de junio de 2026 actualizado por: 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

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

72

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

    • Florida
      • Bradenton, Florida, Estados Unidos, 34210
        • Reclutamiento
        • GSSI Bradenton
        • Contacto:
    • New York
      • Valhalla, New York, Estados Unidos, 10595

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Bebida Placebo
333 mL aliquots 3 times for a total of 1 L over a 30 min period. Time 0 begins post-dose.
Experimental: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Fluid Balance
Periodo de tiempo: Change from baseline, 4 hours
calculated as change in nude body mass from baseline (%)
Change from baseline, 4 hours

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Fluid Balance
Periodo de tiempo: Change from baseline, 4 hours
calculated as change in nude body mass from baseline (g)
Change from baseline, 4 hours
Urine Mass
Periodo de tiempo: Change from baseline, 4 hours
g
Change from baseline, 4 hours
Urine Specific Gravity
Periodo de tiempo: Change from baseline, 4 hours
au
Change from baseline, 4 hours
Urine Osmolality
Periodo de tiempo: Change from baseline, 4 hours
mosmol/kg
Change from baseline, 4 hours
Fluid Retention
Periodo de tiempo: Change from baseline, 4 hours
Percentage (%)
Change from baseline, 4 hours
Free Water Clearance
Periodo de tiempo: Change from baseline, 4 hours
ml/min
Change from baseline, 4 hours
Whole blood sodium concentration
Periodo de tiempo: Change from baseline, 4 hours
mmol/L
Change from baseline, 4 hours
Whole blood potassium concentration
Periodo de tiempo: Change from baseline, 4 hours
mmol/L
Change from baseline, 4 hours
Whole blood glucose concentration
Periodo de tiempo: Change from baseline, 4 hours
mg/dl
Change from baseline, 4 hours
Whole blood hematocrit
Periodo de tiempo: Change from baseline, 4 hours
Percentage (%)
Change from baseline, 4 hours
Whole blood hemoglobin concentration
Periodo de tiempo: Change from baseline, 4 hours
g/dl
Change from baseline, 4 hours
Serum osmolality
Periodo de tiempo: Change from baseline, 4 hours
mosmol/kg
Change from baseline, 4 hours
Serum copeptin concentration
Periodo de tiempo: Change from baseline, 4 hours
pmol/L
Change from baseline, 4 hours
Serum estrogen
Periodo de tiempo: Change from baseline, 4 hours
pg/mL
Change from baseline, 4 hours
Serum progesterone
Periodo de tiempo: Change from baseline, 4 hours
ng/mL
Change from baseline, 4 hours
Serum follicle stimulating hormone (FSH)
Periodo de tiempo: Change from baseline, 4 hours
pg/mL
Change from baseline, 4 hours
Capillary follicle stimulating hormone (FSH)
Periodo de tiempo: At baseline, to determine menstruation status
MIU/mL
At baseline, to determine menstruation status
Salivary Cortisol
Periodo de tiempo: Change from baseline, 4 hours
ng/mL
Change from baseline, 4 hours
Salivary Estradiol
Periodo de tiempo: Change from baseline, 4 hours
pg/mL
Change from baseline, 4 hours
Salivary Progesterone
Periodo de tiempo: Change from baseline, 4 hours
pg/mL
Change from baseline, 4 hours
Low energy availability Questionnaire (LEAF-Q)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: Change from baseline, 4 hours
systolic/diastolic, mm/Hg
Change from baseline, 4 hours
Heart Rate
Periodo de tiempo: Change from baseline, 4 hours
Beats per minute (BPM)
Change from baseline, 4 hours
Adverse Events
Periodo de tiempo: 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de junio de 2026

Finalización primaria (Estimado)

1 de noviembre de 2026

Finalización del estudio (Estimado)

1 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

12 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

12 de junio de 2026

Publicado por primera vez (Actual)

17 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

12 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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