Effect of Glycerol-Electrolyte Beverages on Fluid Balance in Healthy Euhydrated Men and Women at Rest
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Fluid balance
研究概览
简要总结
The objective of this study is to determine the effect of consumption of drinks with varying amounts of glycerol and electrolytes on fluid balance at rest.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •You are 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 as indicated on the general health questionnaire (GHQ), 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
- •Able to speak, write, and read English
- •Provision of written consent to participate
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 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.
研究组 & 干预措施
Control
No sodium, No glycerol
干预措施: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order. (Other)
Sodium only group 1
55 mmol/L sodium
干预措施: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order. (Other)
Sodium and Glycerol group 1
55 mmol/L sodium and 4.6% glycerol
干预措施: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order. (Other)
Sodium only group 2
27.5 mmol/L sodium
干预措施: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order. (Other)
Glycerol only
4.6% glycerol
干预措施: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order. (Other)
Sodium and Glycerol group 2
27.5 mmol/L sodium and 2.3% glycerol
干预措施: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order. (Other)
结局指标
主要结局
Fluid balance
时间窗: Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90,120 and 180 minutes
Change in body mass to the nearest 0.005 kilogram (kg) using a platform scale
次要结局
- Blood pressure(Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90, 120 and 180 minutes)
- Urine mass(Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90, 120 and 180 minutes)
- Urine specific gravity(Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90,120 and 180 minutes)
- Blood glucose(Change from baseline (pre-beverage) to post-beverage Time 0, 60 min, 120 min and 180 minutes)
- Subjective measures of gastrointestinal discomfort and headache(Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90, 120 and 180 minutes)
- Fluid retention(Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90,120 and 180 minutes)
- Blood sodium(Change from baseline (pre-beverage) to post-beverage Time 0, 60 min, 120 min and 180 minutes)
- Percent change in plasma volume(Change from baseline (pre-beverage) to post-beverage Time 0, 60 min, 120 min and 180 minutes)
- Serum glycerol concentration(Change from baseline (pre-beverage) to post-beverage Time 0, 60 min, 120 min and 180 minutes)
- Heart rate(Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90, 120 and 180 minutes)
- Menstrual cycle phase(Female participants log menstrual flow throughout study participation. The three study sessions (2-45 days apart) are scheduled to avoid menses and can be completed in the same menstrual cycle, or in 3 different cycles (3 different months) if needed.)