NCT04240951已完成不适用
Validity of a Prototype Wearable Patch in Measuring Local Sweating Rate and Sweat Electrolyte Concentration During Exercise
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 552
- 试验地点
- 4
- 主要终点
- Sweat chloride concentration
研究概览
简要总结
To determine the validity of a prototype patch in measuring sweating rate and sweat electrolyte concentration during moderate intensity exercise against well-established reference methods in a controlled laboratory and in field conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is male or female
- •Subject is 15-45 years
- •Subject is moderately-trained (engages in moderate-intensity, intermittent, or steady-state exercise at least 4 days per week for at least 1 hour at a time)
- •Subject is capable of moderate-intensity, intermittent exercise for 1-2 hours as assessed by recent training history
- •If participating in Study Session 1, 2, 3, or 4, subject has a treadmill VO2max ≥ 42 ml/kg/min if male or ≥ 38 ml/kg/min if female, as measured during the screening at the GSSI laboratory
- •If participating in Study Session 1, 2, 3, or 4, subject has a normal fasting blood glucose (70-110 mg/dl), as measured during the screening at the GSSI laboratory
- •If participating in Study Session 1, 2, 3, or 4, subject has a normal resting blood pressure (< 140/90 mmHg), as measured during the screening at the GSSI laboratory
- •If participating in Study Session 1, 2, 3, or 4, subject has a normal resting and graded exercise EKG, as measured during the screening at the GSSI laboratory
- •If participating in Study Session 1, 2, 3, or 4, willing to be shaved at patch sites
- •If participating in Study Session 3 or 4, willing to undergo a nude shower by an investigator of the same sex for collection of sweat electrolytes in the whole body wash procedure
- •If participating in Study Session 5 or 6, subject is a trained team-sport athlete currently participating in training/competition at IMG Academy
排除标准
- •Subject is pregnant (self-reported)
- •Subject is a smoker
- •Subject has a body weight that is lighter than 80 pounds
- •Subject has a known or suspected obstructive disease of the gastrointestinal tract, such as diverticulitis or inflammatory bowel disease
- •Subject has a history of problems with the gag reflex
- •Subject has not had previous gastrointestinal surgery
- •Subject has problems with swallowing
- •Subject is planning to have an MRI scan during the time that the CorTemp™ Core Body Temperature Sensor is in the body
- •Subject has slow movement of the gastrointestinal tract
- •Subject has a cardiac pacemaker or other implanted electronic device
- •Subject has asthma or other condition in which breathing can become difficult/labored during exercise (applies to Study Session 1-4 only)
- •Subject is allergic to adhesives
- •Subject is currently taking a medication or oral supplement that could interfere with study results
- •Subject has a condition 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 has been enrolled into a PepsiCo-sponsored study within the past six months
- •Subject has been enrolled into a clinical trial at a laboratory or clinic other than PepsiCo within the past 30 days
- •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 products. 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.
结局指标
主要结局
Sweat chloride concentration
时间窗: 1.5 hours in sessions 1-6
Prototype vs. reference method (regional absorbent patch technique) during exercise
次要结局
- Regional sweating rate(1.5 hours in sessions 1-6)
- Whole body sweat chloride concentration(1.5 hours in sessions 3-4)
- Self-ratings of perceived sweat saltiness vs. sweat electrolyte concentrations(Prior to the start of exercise at sessions 1-6)
- Whole body sweating rate(1.5 hours in sessions 1-6)
- Self-ratings of perceived sweating vs. measured sweating rate(Prior to the start of exercise at sessions 1-6)
- History of exercise-associated muscle cramps(Prior to the start of exercise at sessions 1-6)
- Whole body sweat sodium concentration(1.5 hours in sessions 3-4)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
不适用
Testing of an Electronic Patch During Mild DehydrationDehydrationNCT05129358Mode Sensors AS31
已完成
不适用
NBA G-League Sweat Testing Study: Validity of the Gx Sweat Patch in Measuring Sweating Rate and Sweat Chloride Concentration During On-court Training With Basketball PlayersSweat AnalysisNCT04679532PepsiCo Global R&D65
已完成
不适用
Sweat Sensors for Athletic PerformanceHealthy AdultsNCT03566381Northwestern University4
已完成
不适用
Sweat Rate Measurement With a Sensor (Wearable) in Different Climatic Conditions With Road Cyclists.SweatNCT06308432Universidad Católica San Antonio de Murcia12
终止
不适用
Grasping Rehabilitation With Functional Electrical Stimulation GarmentSpinal Cord InjuriesStrokeNCT03658798Milos Popovic8