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临床试验/NCT04920266
NCT04920266已完成不适用

Validity of a Smart Cap in Measuring Fluid Intake and a Smart Sweat Patch in Measuring Sweat Rate and Sweat Chloride Concentration During Exercise

PepsiCo Global R&D6 个研究点 分布在 1 个国家目标入组 173 人开始时间: 2021年6月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
173
试验地点
6
主要终点
Regional sweating rate

研究概览

简要总结

The main objectives are to determine the validity of a Smart Cap in measuring fluid intake during running and fitness exercise and the validity of a Smart Sweat Patch in measuring sweat rate and sweat chloride concentration during outdoor cycling, running, and fitness exercise. A secondary objective is to compare regional sweating rate and sweat electrolyte concentrations (sodium, chloride, and potassium) on contralateral arms with vs. without tattoos.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
16 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject is male or female
  • Subject is 16-65 years of age
  • Subject is moderately-trained (participates in regular outdoor fitness (~1 h), cycling (1-2 h), or running (0.5-1 h) sessions ≥2x per week)
  • Subject is participating in an instructor-led fitness session, typical training run, or group bicycle ride

排除标准

  • Subject is pregnant
  • Subject is a smoker
  • Subject is taking a medication or oral supplement that could interfere with study results
  • Subject has an allergy to adhesives (e.g., experiences rash reactions to typical adhesive bandages)
  • Subject has ≥ 2 cardiovascular risk factors as assessed on the General Health History Questionnaire
  • Subject has participated in a clinical trial within past 30 days
  • Subject has participated in any PepsiCo trial within past 6 months
  • 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 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

Regional sweating rate

时间窗: Change from baseline to up to 2 hours of exercise

Sweat Patch versus Reference patch method

Regional sweat chloride concentration

时间窗: Change from baseline to up to 2 hours of exercise

Sweat Patch versus Reference patch method

Fluid intake

时间窗: Change from baseline to up to 1 hour of exercise

Smart Cap (sensor) versus Reference method (bottle weight)

次要结局

  • Regional sweat sodium and potassium with versus without tattoos(Change from baseline to up to 2 hours of exercise)
  • Regional sweating rate with versus without tattoos(Change from baseline to up to 2 hours of exercise)
  • Whole body sweat rate(Body mass change from baseline to up to 2 hours of exercise)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (6)

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