- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07653620
Hydration & Female Life Stages
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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Samantha Goldenstein
- Número de telefone: 847-707-3118
- E-mail: GatoradeGSSIIMG@pepsico.com
Estude backup de contato
- Nome: Susan Kwiecien
- Número de telefone: 847-707-3118
- E-mail: GSSIresearchstaff@pepsico.com
Locais de estudo
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Florida
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Bradenton, Florida, Estados Unidos, 34210
- Recrutamento
- GSSI Bradenton
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Contato:
- Samantha Goldenstein
- Número de telefone: 847-707-3118
- E-mail: GatoradeGSSIIMG@pepsico.com
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New York
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Valhalla, New York, Estados Unidos, 10595
- Recrutamento
- GSSI Valhalla
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Contato:
- Susan Kwiecien
- Número de telefone: 847-707-3118
- E-mail: GSSIresearchstaff@pepsico.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador de Placebo: Bebida placebo
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333 mL aliquots 3 times for a total of 1 L over a 30 min period.
Time 0 begins post-dose.
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Experimental: Electrolyte Beverage
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Fluid Balance
Prazo: Change from baseline, 4 hours
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calculated as change in nude body mass from baseline (%)
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Change from baseline, 4 hours
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Fluid Balance
Prazo: Change from baseline, 4 hours
|
calculated as change in nude body mass from baseline (g)
|
Change from baseline, 4 hours
|
|
Urine Mass
Prazo: Change from baseline, 4 hours
|
g
|
Change from baseline, 4 hours
|
|
Urine Specific Gravity
Prazo: Change from baseline, 4 hours
|
au
|
Change from baseline, 4 hours
|
|
Urine Osmolality
Prazo: Change from baseline, 4 hours
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mosmol/kg
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Change from baseline, 4 hours
|
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Fluid Retention
Prazo: Change from baseline, 4 hours
|
Percentage (%)
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Change from baseline, 4 hours
|
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Free Water Clearance
Prazo: Change from baseline, 4 hours
|
ml/min
|
Change from baseline, 4 hours
|
|
Whole blood sodium concentration
Prazo: Change from baseline, 4 hours
|
mmol/L
|
Change from baseline, 4 hours
|
|
Whole blood potassium concentration
Prazo: Change from baseline, 4 hours
|
mmol/L
|
Change from baseline, 4 hours
|
|
Whole blood glucose concentration
Prazo: Change from baseline, 4 hours
|
mg/dl
|
Change from baseline, 4 hours
|
|
Whole blood hematocrit
Prazo: Change from baseline, 4 hours
|
Percentage (%)
|
Change from baseline, 4 hours
|
|
Whole blood hemoglobin concentration
Prazo: Change from baseline, 4 hours
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g/dl
|
Change from baseline, 4 hours
|
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Serum osmolality
Prazo: Change from baseline, 4 hours
|
mosmol/kg
|
Change from baseline, 4 hours
|
|
Serum copeptin concentration
Prazo: Change from baseline, 4 hours
|
pmol/L
|
Change from baseline, 4 hours
|
|
Serum estrogen
Prazo: Change from baseline, 4 hours
|
pg/mL
|
Change from baseline, 4 hours
|
|
Serum progesterone
Prazo: Change from baseline, 4 hours
|
ng/mL
|
Change from baseline, 4 hours
|
|
Serum follicle stimulating hormone (FSH)
Prazo: Change from baseline, 4 hours
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pg/mL
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Change from baseline, 4 hours
|
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Capillary follicle stimulating hormone (FSH)
Prazo: At baseline, to determine menstruation status
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MIU/mL
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At baseline, to determine menstruation status
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Salivary Cortisol
Prazo: Change from baseline, 4 hours
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ng/mL
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Change from baseline, 4 hours
|
|
Salivary Estradiol
Prazo: Change from baseline, 4 hours
|
pg/mL
|
Change from baseline, 4 hours
|
|
Salivary Progesterone
Prazo: Change from baseline, 4 hours
|
pg/mL
|
Change from baseline, 4 hours
|
|
Low energy availability Questionnaire (LEAF-Q)
Prazo: at screening to determine menstrual history
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Validated questionnaire that assesses injury, gastrointestinal symptoms, and menstrual function, score > 8 at risk for LEA
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at screening to determine menstrual history
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Menopause Rating Scale (MRS)
Prazo: at baseline to determine menopause symptoms
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5-point likert scale assessing symptoms as none (0) to very severe (4), > score mean more severe/greater number of symptoms
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at baseline to determine menopause symptoms
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Feeling Scale (FS)
Prazo: change from baseline, 4 hours
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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
|
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Gastrointestinal discomfort and headache (VAS)
Prazo: change from baseline, 4 hours
|
100-pt visual analog scale anchored from none (0) to severe (100), > score is associated with increased symptoms
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change from baseline, 4 hours
|
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Mental and physical energy and fatigue (VAS)
Prazo: change from baseline, 4 hours
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100-pt visual analog scale anchored from none (0) to severe (100), > score is associated with stronger feelings
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change from baseline, 4 hours
|
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Blood Pressure
Prazo: Change from baseline, 4 hours
|
systolic/diastolic, mm/Hg
|
Change from baseline, 4 hours
|
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Heart Rate
Prazo: Change from baseline, 4 hours
|
Beats per minute (BPM)
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Change from baseline, 4 hours
|
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Adverse Events
Prazo: Through study completion, an average of 4 weeks for pre- and peri-menopausal subjects and 2 weeks for post-menopausal subjects.
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Documented changes in health and symptoms as a safety measurement
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Through study completion, an average of 4 weeks for pre- and peri-menopausal subjects and 2 weeks for post-menopausal subjects.
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PEP-2604
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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