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临床试验/NCT06042270
NCT06042270已完成不适用

Thermoregulatory Responses of Betaine Supplementation in Firefighters During Live Burn

Michael J. Ormsbee2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2023年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
17
试验地点
2
主要终点
Subjective measures

研究概览

简要总结

The goal of this clinical trial is to compare betaine supplementation to placebo in firefighters undergoing live burn training regarding thermoregulation and inflammation. The main questions it aims to answer are:

  • Does betaine supplementation mitigate rises in core temperature during firefighter live burn training?
  • Does betaine supplementation decrease inflammation from firefighter training?
  • Does betaine supplementation increase total body water stores?

Participants will supplement with betaine for 1 month and complete:

  • Total Body Water measures
  • Body Composition measures
  • Live Burn training with Core Temperature Measurements
  • Provide Salivary samples

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Structural Firefighter

排除标准

  • • Participants have a cardiometabolic disease for which they take prescribed medications
  • Participants consume supplements known to impact hydration status or performance that they are not willing to stop taking for the study
  • Participants are pregnant
  • Female participants that have irregular menstrual cycles
  • Participants are injured and would not be able to fulfill the live burn scenario
  • Participants have sickle cell disease
  • Participants have experienced heat stroke within the last 2 years

结局指标

主要结局

Subjective measures

时间窗: immediately before and immediately after the completion of the live burn

Visual analog scales will be given to participants for subjective thermal sensation, rate of perceived exertion, and thirst

Thermoregulation

时间窗: 10 minutes before the live burn, during the ~15 minute live burn, 10, 20, and 30 minutes after the live burn.

Core temperature (Degrees C), skin temperature (Degrees C)

Stress (enzyme linked immunoassays)

时间窗: before, immediately after, 10 minutes, and 20 minutes after live burn

Salivary expression of Testosterone, Cortisol, interleukin-8, and interleukin 6 will be measured.

Sweat Rate

时间窗: immediately before and immediately after the completion of the live burn

Changes in body weight in kg will be used to find loss of sweat in L

Stress (respiration efficiency)

时间窗: immediately before and immediately after the completion of the live burn

Air tank pounds per square inch (PSI) will be recorded

Sweat Content

时间窗: immediately before and immediately after the completion of the live burn

Tegaderm patches will be worn during the live burn to analyze sodium concentration in sweat.

次要结局

  • Chronic Stress (enzyme linked immunoassays)(Before supplementation and after 4 weeks of supplementation)
  • Chronic Stress (vitals) professional firefighters.(Before supplementation and after 4 weeks of supplementation)
  • Fluid Compartment Volumes (Bioelectrical Impedance Spectrocopy) professional firefighters.(Before supplementation and after 4 weeks of supplementation)

研究者

发起方
Michael J. Ormsbee
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Michael J. Ormsbee

Director

Florida State University

研究点 (2)

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