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临床试验/NCT06995768
NCT06995768招募中不适用

Normative Data for Sweating Rate, Sweat Sodium Concentration and Sweat Sodium Loss in Female Athlete

PepsiCo Global R&D1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2025年4月22日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
Regional sweat [Na+]

研究概览

简要总结

The main objectives are to determine sweat sodium concentration [Na+], whole body sweat rate (WBSR) and rate of sweat sodium loss (RSSL) in female athletes aged 13 and above during their normal planned training session across various sports (basketball, soccer, volleyball, cheer, flag football and softball).

详细描述

The testing procedures will follow the standardized Gatorade Sports Sciences GSSI sweat testing protocol using the absorbent sweat patch technique, to measure local sweat [Na+], which will be normalized to whole-body sweat [Na+]. Whole-body sweat rate (WBSR) will be calculated based on changes in exercise body mass, pre to post training, and adjusted for food and fluid intake, as well as urine and stool loss. The rate of sweat sodium loss (RSSL) will be determined as the product of sweat [Na+] and WBSR.

Secondary outcomes are pre-exercise hydration status measured by urine specific gravity (USG) and estimation of menstrual cycle phase collected by self-report date of last menstrual cycle.

Athletes will complete a single day of testing, unless a repeat test is requested by the team's performance staff. In this case, athletes will undergo the exact same protocol as described above.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
13 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Subject is female
  • Subject is 13yrs+
  • Subject has been cleared for sport participation by their personal or team physician and/or coach-led practice/training.
  • Subject is participating in sport on the youth/ amateur/ collegiate/professional/elite level
  • If under 18, a parental/guardian consent form will be completed.

排除标准

  • As this study is undertaken at the athletes training facility, the medical staff at the team/club will advise on who should/ should not take part.
  • Subject has an allergy to adhesives (e.g., experiences rash reactions to typical adhesive bandages

结局指标

主要结局

Regional sweat [Na+]

时间窗: One day from start through end of a single coach-led normal training practice session. Practice duration will be dictated by coaching staff.

Absorbent patch technique (3M TegadermTM + Pad; 3M, St. Paul, MN; pad size 10 cm2 with an absorbent capacity of \~1.3 g) to left and right dorsal arm. An additional patch on the right scapula may be added depending on the accessibility to the sites on the body and the nature of the sport. Analyzed using a HORIBA (LAQUAtwin Na-11)

Whole body sweat rate (WBSR) WBSR

时间窗: One day from start through end of a single coach-led training normal training practice session. Practice duration will be dictated by coaching staff.A

Pre- versus post body mass on scale, taking into account food and fluid intake, urine and stool output

Rate of sweat sodium loss (RSSL)

时间窗: One day from start through end of a single coach-led normal training practice session. Duration will be dictated by coaching staff.

The rate of sodium sweat loss (RSSL) will be determined as the product of sweat \[Na+\] and whole-body sweat rate (WBSR)

次要结局

  • Urine specific gravity (USG)(Pre-exercise at one coach-led normal training practice session.)
  • Fluid intake(One day from start through end of a single coach-led normal training practice session. Duration will be dictated by coaching staff.)
  • Carbohydrate intake(One day from start through end of a single coach-led normal training practice session. Duration will be dictated by coaching staff.)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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