Clinical trial NCT06042270: Firefighter Thermoregulatory Responses in Active Fire with Betaine Supplementation
Official title: Thermoregulatory Responses of Betaine Supplementation in Firefighters During Live Burn
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Temperature Changes
Body Water Dehydration
Inflammation
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* Structural Firefighter

Exclusion Criteria:

* • 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

Primary outcomes:
measure: Thermoregulation
timeFrame: 10 minutes before the live burn, during the ~15 minute live burn, 10, 20, and 30 minutes after the live burn.
measure: Stress (enzyme linked immunoassays)
timeFrame: before, immediately after, 10 minutes, and 20 minutes after live burn
measure: Stress (respiration efficiency)
timeFrame: immediately before and immediately after the completion of the live burn
measure: Sweat Rate
timeFrame: immediately before and immediately after the completion of the live burn
measure: Sweat Content
timeFrame: immediately before and immediately after the completion of the live burn
measure: Subjective measures
timeFrame: immediately before and immediately after the completion of the live burn
Secondary outcomes:
measure: Chronic Stress (enzyme linked immunoassays)
timeFrame: Before supplementation and after 4 weeks of supplementation
measure: Chronic Stress (vitals) professional firefighters.
timeFrame: Before supplementation and after 4 weeks of supplementation
measure: Fluid Compartment Volumes (Bioelectrical Impedance Spectrocopy) professional firefighters.
timeFrame: Before supplementation and after 4 weeks of supplementation
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Institute of Sports Science and Medicine
state: Florida
Study officials:
References: