Effects of Beverage Volume, Glycerol Concentration, and Sodium Concentration 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
- 60
- 试验地点
- 3
- 主要终点
- Fluid balance
研究概览
简要总结
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)
- •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
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
Base with glycerol beverage 1
No electrolytes, higher glycerol, lower volume
干预措施: Base with glycerol, no electrolytes beverage 1 (Other)
Base with glycerol beverage 2
No electrolytes, lower glycerol, mid-volume
干预措施: Base with glycerol, no electrolytes beverage 2 (Other)
Base with glycerol beverage 3
No electrolytes, higher glycerol, higher volume
干预措施: Base with glycerol, no electrolytes beverage 3 (Other)
Placebo beverage
Base beverage, no electrolytes, no glycerol
干预措施: Placebo beverage, kiwi-strawberry flavor (Other)
Electrolyte solution without glycerol beverage 1
Higher electrolytes lower volume
干预措施: Electrolyte solution without glycerol beverage 1 (Other)
Electrolyte solution without glycerol beverage 2
Lower electrolytes mid-volume
干预措施: Electrolyte solution without glycerol beverage 2 (Other)
Electrolyte solution with glycerol beverage 1
Lower electrolytes, lower glycerol, lower volume
干预措施: Electrolyte solution with glycerol beverage 1 (Other)
Electrolyte solution without glycerol beverage 3
Higher electrolytes higher volume
干预措施: Electrolyte solution without glycerol beverage 3 (Other)
Electrolyte solution with glycerol beverage 3
Higher electrolytes, higher glycerol, higher volume
干预措施: Electrolyte solution with glycerol beverage 3 (Other)
Electrolyte solution with glycerol beverage 2
Higher electrolytes, higher glycerol, lower volume
干预措施: Electrolyte solution with glycerol beverage 2 (Other)
结局指标
主要结局
Fluid balance
时间窗: 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 %
次要结局
- Urine mass(Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes)
- Urine specific gravity(Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes)
- Urine osmolality(Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes)
- Whole blood hematocrit(Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes)
- Whole blood hemoglobin concentration(Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes)
- Serum sodium concentration(Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes)
- Serum potassium concentration(Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes)
- Serum chloride concentration (mmol/L)(Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes)
- Serum glucose concentration(Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes)
- Serum glycerol concentration(Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes)
- Serum copeptin concentration(Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes)
- Serum osmolality(Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes)
- Blood pressure(Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes)
- Heart rate(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)(Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes)
- Menstrual categorization(Screening visit)
- Adverse Events(From Screening (Visit 1) through the fifth and final beverage testing day (Visit 6))