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
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Samantha Goldenstein
- 电话号码:847-707-3118
- 邮箱:GatoradeGSSIIMG@pepsico.com
研究联系人备份
- 姓名:Susan Kwiecien
- 电话号码:847-707-3118
- 邮箱:GSSIresearchstaff@pepsico.com
学习地点
-
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Florida
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Bradenton、Florida、美国、34210
- 招聘中
- GSSI Bradenton
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接触:
- Samantha Goldenstein
- 电话号码:847-707-3118
- 邮箱:GatoradeGSSIIMG@pepsico.com
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-
New York
-
Valhalla、New York、美国、10595
- 招聘中
- GSSI Valhalla
-
接触:
- Susan Kwiecien
- 电话号码:847-707-3118
- 邮箱:GSSIresearchstaff@pepsico.com
-
-
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较:安慰剂饮料
|
333 mL aliquots 3 times for a total of 1 L over a 30 min period.
Time 0 begins post-dose.
|
|
实验性的: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.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Fluid Balance
大体时间:Change from baseline, 4 hours
|
calculated as change in nude body mass from baseline (%)
|
Change from baseline, 4 hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Fluid Balance
大体时间:Change from baseline, 4 hours
|
calculated as change in nude body mass from baseline (g)
|
Change from baseline, 4 hours
|
|
Urine Mass
大体时间:Change from baseline, 4 hours
|
g
|
Change from baseline, 4 hours
|
|
Urine Specific Gravity
大体时间:Change from baseline, 4 hours
|
au
|
Change from baseline, 4 hours
|
|
Urine Osmolality
大体时间:Change from baseline, 4 hours
|
mosmol/kg
|
Change from baseline, 4 hours
|
|
Fluid Retention
大体时间:Change from baseline, 4 hours
|
Percentage (%)
|
Change from baseline, 4 hours
|
|
Free Water Clearance
大体时间:Change from baseline, 4 hours
|
ml/min
|
Change from baseline, 4 hours
|
|
Whole blood sodium concentration
大体时间:Change from baseline, 4 hours
|
mmol/L
|
Change from baseline, 4 hours
|
|
Whole blood potassium concentration
大体时间:Change from baseline, 4 hours
|
mmol/L
|
Change from baseline, 4 hours
|
|
Whole blood glucose concentration
大体时间:Change from baseline, 4 hours
|
mg/dl
|
Change from baseline, 4 hours
|
|
Whole blood hematocrit
大体时间:Change from baseline, 4 hours
|
Percentage (%)
|
Change from baseline, 4 hours
|
|
Whole blood hemoglobin concentration
大体时间:Change from baseline, 4 hours
|
g/dl
|
Change from baseline, 4 hours
|
|
Serum osmolality
大体时间:Change from baseline, 4 hours
|
mosmol/kg
|
Change from baseline, 4 hours
|
|
Serum copeptin concentration
大体时间:Change from baseline, 4 hours
|
pmol/L
|
Change from baseline, 4 hours
|
|
Serum estrogen
大体时间:Change from baseline, 4 hours
|
pg/mL
|
Change from baseline, 4 hours
|
|
Serum progesterone
大体时间:Change from baseline, 4 hours
|
ng/mL
|
Change from baseline, 4 hours
|
|
Serum follicle stimulating hormone (FSH)
大体时间:Change from baseline, 4 hours
|
pg/mL
|
Change from baseline, 4 hours
|
|
Capillary follicle stimulating hormone (FSH)
大体时间:At baseline, to determine menstruation status
|
MIU/mL
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At baseline, to determine menstruation status
|
|
Salivary Cortisol
大体时间:Change from baseline, 4 hours
|
ng/mL
|
Change from baseline, 4 hours
|
|
Salivary Estradiol
大体时间:Change from baseline, 4 hours
|
pg/mL
|
Change from baseline, 4 hours
|
|
Salivary Progesterone
大体时间:Change from baseline, 4 hours
|
pg/mL
|
Change from baseline, 4 hours
|
|
Low energy availability Questionnaire (LEAF-Q)
大体时间: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
|
at screening to determine menstrual history
|
|
Menopause Rating Scale (MRS)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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
大体时间:Change from baseline, 4 hours
|
systolic/diastolic, mm/Hg
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Change from baseline, 4 hours
|
|
Heart Rate
大体时间:Change from baseline, 4 hours
|
Beats per minute (BPM)
|
Change from baseline, 4 hours
|
|
Adverse Events
大体时间: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.
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.