NCT07653620招募中不适用
Effect of Female Life Stage on Rehydration With Water vs. an Electrolyte Solution After Overnight Fast/Fluid Restriction
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Fluid Balance
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •• 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
排除标准
- •• 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.
研究组 & 干预措施
Placebo Beverage
Placebo Comparator
干预措施: placebo beverage (Other)
Electrolyte Beverage
Experimental
干预措施: electrolyte beverage (Other)
结局指标
主要结局
Fluid Balance
时间窗: Change from baseline, 4 hours
calculated as change in nude body mass from baseline (%)
次要结局
- Fluid Balance(Change from baseline, 4 hours)
- Urine Mass(Change from baseline, 4 hours)
- Urine Specific Gravity(Change from baseline, 4 hours)
- Urine Osmolality(Change from baseline, 4 hours)
- Fluid Retention(Change from baseline, 4 hours)
- Free Water Clearance(Change from baseline, 4 hours)
- Whole blood sodium concentration(Change from baseline, 4 hours)
- Whole blood potassium concentration(Change from baseline, 4 hours)
- Whole blood glucose concentration(Change from baseline, 4 hours)
- Whole blood hematocrit(Change from baseline, 4 hours)
- Whole blood hemoglobin concentration(Change from baseline, 4 hours)
- Serum osmolality(Change from baseline, 4 hours)
- Serum copeptin concentration(Change from baseline, 4 hours)
- Serum estrogen(Change from baseline, 4 hours)
- Serum progesterone(Change from baseline, 4 hours)
- Serum follicle stimulating hormone (FSH)(Change from baseline, 4 hours)
- Capillary follicle stimulating hormone (FSH)(At baseline, to determine menstruation status)
- Salivary Cortisol(Change from baseline, 4 hours)
- Salivary Estradiol(Change from baseline, 4 hours)
- Salivary Progesterone(Change from baseline, 4 hours)
- Low energy availability Questionnaire (LEAF-Q)(at screening to determine menstrual history)
- Menopause Rating Scale (MRS)(at baseline to determine menopause symptoms)
- Feeling Scale (FS)(change from baseline, 4 hours)
- Gastrointestinal discomfort and headache (VAS)(change from baseline, 4 hours)
- Mental and physical energy and fatigue (VAS)(change from baseline, 4 hours)
- Blood Pressure(Change from baseline, 4 hours)
- Heart Rate(Change from baseline, 4 hours)
- Adverse Events(Through study completion, an average of 4 weeks for pre- and peri-menopausal subjects and 2 weeks for post-menopausal subjects.)
研究者
研究点 (2)
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