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FFBET: Firefighter Thermoregulatory Responses in Active Fire With Betaine Supplementation

Sponsor
Michael J. Ormsbee (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06042270
Collaborator
(none)
20
Enrollment
2
Arms
12
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Betaine
  • Dietary Supplement: Placebo
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Thermoregulatory Responses of Betaine Supplementation in Firefighters During Live Burn
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

10 participants will be given rice-flour as a placebo

Dietary Supplement: Placebo
3 grams per day for ~4 weeks
Other Names:
  • Rice Flour

    		•
    Active Comparator: Betaine

    10 participants will be given betaine

    Dietary Supplement: Betaine
    3 grams per day for ~4 weeks
    Other Names:
  • Trimethylglycine
  • Betaine Anhydrous

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Determine if BET supplementation impacts the thermal response in professional firefighters during live burn training. [1 month]

      To address Aim 1, we will measure and record changes in core temperature and skin temperature. Temperature will be measured before, during, and after the live burn. Physiological strain index will be calculated based off initial core temperature and heart rate, as well as ending core temperature and heart rate during the live burn. Tegaderm patches will be worn during the live burn to analyze sodium concentration in sweat. Additionally, subjective thermal sensation, rate of perceived exertion, and thirst will be measured before and after the live burn.

    2. Determine if BET supplementation impacts acute physiological stress in professional firefighters during a live burn. [1 month]

      To address Aim 2, we will collect saliva samples before, immediately after, 10 minutes, and 20 minutes after live burn. These saliva samples will be analyzed for cortisol and testosterone to determine Testosterone Cortisol ratios and markers of inflammation (Interleukin 8 [IL-8] and interleukin-6 [IL-6]). Additionally, heart rate will be measured throughout the live burn. Last, pounds per square inch (PSI) in the firefighter's air tank will be recorded to indicate the amount of air usage.

    Secondary Outcome Measures

    1. Determine if BET supplementation decreases chronic physiological stress in professional firefighters. [2 months]

      To address Aim 3, we will collect saliva samples before and after the 4-week supplementation period to be analyzed for testosterone, cortisol, uric acid, and c-reactive protein. Resting blood pressure, total body water, and heart rate will also be measured.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Michael J. Ormsbee

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michael J. Ormsbee, Director, Florida State University
    ClinicalTrials.gov Identifier:
    NCT06042270
    Other Study ID Numbers:
    • STUDY00004218
    First Posted:
    Sep 18, 2023
    Last Update Posted:
    Sep 18, 2023
    Last Verified:
    Sep 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dehydration
    Inflammation
    Body Temperature Changes
    Betaine

    Study Results

    No Results Posted as of Sep 18, 2023