NCT07217834已完成不适用
Effects of a Glycerol-Electrolyte Beverage on Fluid Balance in Healthy Euhydrated Men and Women
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Fluid balance
研究概览
简要总结
Glycerol and sodium are osmotically-active ingredients that promote fluid retention via renal water reabsorption. The purpose of this study is to compare the effects of a glycerol-electrolyte beverage on fluid balance in healthy euhydrated men and women
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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, laxatives, weight loss drugs)
- •Subject has no health conditions that would interfere with the study (e.g. cardiovascular, renal, or metabolic diseases)
- •Subject is not allergic to fuji apple pear flavoring
- •Subject is not allergic to Stevia
- •Subject is willing to avoid alcohol consumption 24 hours prior to visits
- •Subject is willing to fast overnight (~8-10 hours) prior to visits
- •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 study session.
- •Willing and able to provide signed informed consent to participate in the study and to comply with all study procedures and scheduled visits.
排除标准
- •Subject has participated in a clinical trial within the past 30 days
- •Subject has participated in any PepsiCo trial within past 3 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.
研究组 & 干预措施
Placebo Beverage
Placebo Comparator
Base beverage, no electrolytes, no glycerol
干预措施: Placebo beverage, kiwi-strawberry flavor (Other)
Experimental Beverage
Experimental
Glycerol beverage with electrolytes
干预措施: Experimental glycerol beverage, kiwi-strawberry flavor (Other)
结局指标
主要结局
Fluid balance
时间窗: Through study completion, average of 3 weeks
Calculated as change in nude body mass, %
次要结局
- Beverage Hydration Index(Through study completion, average of 3 weeks)
- Fluid Balance(Through study completion, average of 3 weeks)
- Urine Mass(Through study completion, average of 3 weeks)
- Urine specific gravity(Through study completion, average of 3 weeks)
- Blood Pressure(Through study completion, average of 3 weeks)
- Heart Rate(Through study completion, average of 3 weeks)
- Subjective measures of thirst, gastrointestinal discomfort, lightheadedness and headache(Through study completion, average of 3 weeks)
- Menstrual categorization(Reported by female subjects one time at screening visit.)
- Adverse Events(Through study completion, average of 3 weeks.)
研究者
研究点 (2)
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