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CompletedNCT06042270FFBETUpdated Oct 17, 2024

Firefighter Thermoregulatory Responses in Active Fire with Betaine Supplementation

An interventional study of Betaine and Placebo in Body Temperature Changes, Body Water Dehydration and Inflammation, sponsored by Michael J. Ormsbee. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-17.

Sponsored by Michael J. Ormsbee · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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
02

Conditions studied

  • Body Temperature Changes
  • Body Water Dehydration
  • Inflammation
03

In context

Body Temperature Changes

97 studies on the registry are indexed under Body Temperature Changes; 20 are open to participants now.

This study's enrollment of 17 is below the median of 40 across 68 interventional studies indexed under Body Temperature Changes.

Browse Body Temperature Changes studies →

Lead sponsor

This is the only study on the registry with Michael J. Ormsbee as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Structural Firefighter

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
17 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    10 participants will be given rice-flour as a placebo

    Dietary Supplement: Placebo

  • Active comparator
    Betaine

    10 participants will be given betaine

    Dietary Supplement: Betaine

Interventions

  • Dietary supplementBetaine

    3 grams per day for \~4 weeks

    Also known as: Trimethylglycine, Betaine Anhydrous

  • Dietary supplementPlacebo

    3 grams per day for \~4 weeks

    Also known as: Rice Flour

06

What researchers measure

Primary outcomes

  1. Thermoregulation

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

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

  2. Stress (enzyme linked immunoassays)

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

    Time frame: before, immediately after, 10 minutes, and 20 minutes after live burn

  3. Stress (respiration efficiency)

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

    Time frame: immediately before and immediately after the completion of the live burn

  4. Sweat Rate

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

    Time frame: immediately before and immediately after the completion of the live burn

  5. Sweat Content

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

    Time frame: immediately before and immediately after the completion of the live burn

  6. Subjective measures

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

    Time frame: immediately before and immediately after the completion of the live burn

Secondary outcomes

  1. Chronic Stress (enzyme linked immunoassays)

    Saliva will be analyzed for testosterone, cortisol, uric acid, and c-reactive protein

    Time frame: Before supplementation and after 4 weeks of supplementation

  2. Chronic Stress (vitals) professional firefighters.

    Resting blood pressure in mmHg and heart rate in beats per minute will be measured.

    Time frame: Before supplementation and after 4 weeks of supplementation

  3. Fluid Compartment Volumes (Bioelectrical Impedance Spectrocopy) professional firefighters.

    Intracellular fluid volume (L), extracellular fluid volume (L), plasma volume (L), total body water (L)

    Time frame: Before supplementation and after 4 weeks of supplementation

07

Study locations

1 site
  • Institute of Sports Science and Medicine
    Tallahassee, Florida 32301, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06042270
Lead sponsor
Michael J. Ormsbee
Responsible party
Michael J. Ormsbee (Director, Florida State University) — Sponsor-investigator
First posted
Sep 18, 2023
Start date
Dec 20, 2023
Primary completion
Mar 1, 2024
Completion
Sep 1, 2024
Last update
Oct 17, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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