search
Back to results

Firefighter Thermoregulatory Responses in Active Fire With Betaine Supplementation (FFBET)

Primary Purpose

Body Temperature Changes, Body Water Dehydration, Inflammation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Betaine
Placebo
Sponsored by
Michael J. Ormsbee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Body Temperature Changes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Placebo

    Betaine

    Arm Description

    10 participants will be given rice-flour as a placebo

    10 participants will be given betaine

    Outcomes

    Primary Outcome Measures

    Determine if BET supplementation impacts the thermal response in professional firefighters during live burn training.
    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.
    Determine if BET supplementation impacts acute physiological stress in professional firefighters during a live burn.
    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

    Determine if BET supplementation decreases chronic physiological stress in professional firefighters.
    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.

    Full Information

    First Posted
    August 25, 2023
    Last Updated
    September 11, 2023
    Sponsor
    Michael J. Ormsbee
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06042270
    Brief Title
    Firefighter Thermoregulatory Responses in Active Fire With Betaine Supplementation
    Acronym
    FFBET
    Official Title
    Thermoregulatory Responses of Betaine Supplementation in Firefighters During Live Burn
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    March 2024 (Anticipated)
    Study Completion Date
    September 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Michael J. Ormsbee

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Body Temperature Changes, Body Water Dehydration, Inflammation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    10 participants will be given rice-flour as a placebo
    Arm Title
    Betaine
    Arm Type
    Active Comparator
    Arm Description
    10 participants will be given betaine
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Betaine
    Other Intervention Name(s)
    Trimethylglycine, Betaine Anhydrous
    Intervention Description
    3 grams per day for ~4 weeks
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Rice Flour
    Intervention Description
    3 grams per day for ~4 weeks
    Primary Outcome Measure Information:
    Title
    Determine if BET supplementation impacts the thermal response in professional firefighters during live burn training.
    Description
    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.
    Time Frame
    1 month
    Title
    Determine if BET supplementation impacts acute physiological stress in professional firefighters during a live burn.
    Description
    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.
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    Determine if BET supplementation decreases chronic physiological stress in professional firefighters.
    Description
    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.
    Time Frame
    2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Liliana Renteria
    Phone
    8506451016
    Email
    lir20@fsu.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michael Ormsbee, PhD
    Email
    mormsbee@fsu.edu

    12. IPD Sharing Statement

    Learn more about this trial

    Firefighter Thermoregulatory Responses in Active Fire With Betaine Supplementation

    We'll reach out to this number within 24 hrs