饮料量，甘油浓度和钠浓度对健康的男性和女性的液体平衡的影响
The presence of certain ingredients such as sodium and glycerol can facilitate retention of the fluid consumed via renal water reabsorption. To maintain overall whole-body fluid balance, it is important that ingested fluid is retained in the body instead of losing it through urination.
The purpose of this study is to determine the effect of sodium and glycerol concentrations at various fluid intake volumes on fluid balance in healthy, euhydrated men and women.
研究概览
地位
条件
干预/治疗
- 其他：Placebo beverage, kiwi-strawberry flavor
- 其他：Electrolyte solution without glycerol beverage 1
- 其他：Electrolyte solution without glycerol beverage 2
- 其他：Electrolyte solution without glycerol beverage 3
- 其他：Electrolyte solution with glycerol beverage 1
- 其他：Electrolyte solution with glycerol beverage 2
- 其他：Electrolyte solution with glycerol beverage 3
- 其他：Base with glycerol, no electrolytes beverage 1
- 其他：Base with glycerol, no electrolytes beverage 2
- 其他：Base with glycerol, no electrolytes beverage 3
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Florida
-
Bradenton、Florida、美国、34210
- IMG Academy/GSSI Bradenton Gatorade Sports Science Institute
-
St. Petersburg、Florida、美国、33705
- GCP Research
-
-
New York
-
Valhalla、New York、美国、10595
- Gatorade Sports Science Institute
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Subject is male or female
- If female, subject is not pregnant
- Subject is 18-50 years of age, inclusive
- Subject is at least 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)
- Subject does not smoke (or has quit for at least 6 months)
- Subject is not taking medication that may interfere with the study (e.g., diuretics)
- Subject has no health conditions that would interfere with the study (e.g. cardiovascular, renal, or metabolic diseases)
- Subject is willing to avoid alcohol consumption 24 hours prior to visit(s)
- Subject is willing to fast overnight (~8-12 hours)
- Subject is willing to refrain from vigorous exercise for 24 hours
- Subject is willing to eat the exact same food the day prior to each visit to the laboratory
- Provision of written consent to participate
Exclusion Criteria:
- Subject has participated in a clinical trial within the past 30 days
- Subject has participated in any PepsiCo trial within past 6 months
- Subject 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
- Subject 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 subject 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：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：Placebo beverage
Base beverage, no electrolytes, no glycerol |
9.3.oz 3 times for a total of 28 oz over a 35 min period followed by 25 min rest until Time 0 post-dose |
|
实验性的：Electrolyte solution without glycerol beverage 1
Higher electrolytes lower volume |
4 oz 3 times for a total of 12 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
实验性的：Electrolyte solution without glycerol beverage 2
Lower electrolytes mid-volume |
6.7 oz 3 times for a total of 20 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
实验性的：Electrolyte solution without glycerol beverage 3
Higher electrolytes higher volume |
9.3.oz 3 times for a total of 28 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
实验性的：Electrolyte solution with glycerol beverage 1
Lower electrolytes, lower glycerol, lower volume |
4 oz 3 times for a total of 12 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
实验性的：Electrolyte solution with glycerol beverage 2
Higher electrolytes, higher glycerol, lower volume |
4 oz 3 times for a total of 12 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
实验性的：Electrolyte solution with glycerol beverage 3
Higher electrolytes, higher glycerol, higher volume |
9.3.oz 3 times for a total of 28 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
实验性的：Base with glycerol beverage 1
No electrolytes, higher glycerol, lower volume |
4 oz 3 times for a total of 12 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
实验性的：Base with glycerol beverage 2
No electrolytes, lower glycerol, mid-volume |
6.7 oz 3 times for a total of 20 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
实验性的：Base with glycerol beverage 3
No electrolytes, higher glycerol, higher volume |
9.3.oz 3 times for a total of 28 oz over a 35 min period followed by 25 min rest until Time 0 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 (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
Calculated as change in body mass kg and % |
Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Urine mass
大体时间：Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
(g) |
Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
|
Urine specific gravity
大体时间：Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
(au) |
Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
|
Urine osmolality
大体时间：Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
(mosmol/kg) |
Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
|
Whole blood hematocrit
大体时间：Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
(%) |
Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
|
Whole blood hemoglobin concentration
大体时间：Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
(g/dl) |
Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
|
Serum sodium concentration
大体时间：Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
(mmol/L) |
Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
|
Serum potassium concentration
大体时间：Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
(mmol/L) |
Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
|
Serum chloride concentration (mmol/L)
大体时间：Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
(mmol/L) |
Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
|
Serum glucose concentration
大体时间：Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
(mg/dl) |
Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
|
Serum glycerol concentration
大体时间：Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
(mmol/L) |
Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
|
Serum copeptin concentration
大体时间：Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
(pmol/L) |
Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
|
Serum osmolality
大体时间：Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
(mosmol/kg) |
Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
|
|
Blood pressure
大体时间：Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
(systolic/diastolic) (mmHg) |
Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
|
Heart rate
大体时间：Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
(bpm) |
Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
|
Subjective measures of gastrointestinal discomfort and headache (VAS)
大体时间：Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
Rated on a 100 point scale from none to severe for headache, lightheaded, stomach upset, nausea, burping, stomach bloating, abdominal discomfort, stomach fullness, vomiting, diarrhea). |
Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
|
|
Menstrual categorization
大体时间：Screening visit
|
Current status (e.g., contraception, regular periods or not, etc.) |
Screening visit
|
|
Adverse Events
大体时间：From Screening (Visit 1) through the fifth and final beverage testing day (Visit 6)
|
Documented changes in health and symptoms |
From Screening (Visit 1) through the fifth and final beverage testing day (Visit 6)
|
合作者和调查者
调查人员
- 首席研究员：Lindsay Baker, PhD、PepsiCo R&D/Gatorade and Sports Science Institute
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
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.