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Firefighter Thermoregulatory Responses in Active Fire with Betaine Supplementation

Thermoregulatory Responses of Betaine Supplementation in Firefighters During Live Burn

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06042270
Acronym
FFBET
Enrollment
17
Registered
2023-09-18
Start date
2023-12-20
Completion date
2024-09-01
Last updated
2024-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Temperature Changes, Body Water Dehydration, Inflammation

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

Interventions

DIETARY_SUPPLEMENTBetaine

3 grams per day for \ 4 weeks

DIETARY_SUPPLEMENTPlacebo

3 grams per day for \ 4 weeks

Sponsors

Michael J. Ormsbee
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Subjective measuresimmediately before and immediately after the completion of the live burnVisual analog scales will be given to participants for subjective thermal sensation, rate of perceived exertion, and thirst
Sweat Rateimmediately before and immediately after the completion of the live burnChanges in body weight in kg will be used to find loss of sweat in L
Thermoregulation10 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)
Sweat Contentimmediately before and immediately after the completion of the live burnTegaderm patches will be worn during the live burn to analyze sodium concentration in sweat.
Stress (enzyme linked immunoassays)before, immediately after, 10 minutes, and 20 minutes after live burnSalivary expression of Testosterone, Cortisol, interleukin-8, and interleukin 6 will be measured.
Stress (respiration efficiency)immediately before and immediately after the completion of the live burnAir tank pounds per square inch (PSI) will be recorded

Secondary

MeasureTime frameDescription
Chronic Stress (vitals) professional firefighters.Before supplementation and after 4 weeks of supplementationResting blood pressure in mmHg and heart rate in beats per minute will be measured.
Fluid Compartment Volumes (Bioelectrical Impedance Spectrocopy) professional firefighters.Before supplementation and after 4 weeks of supplementationIntracellular fluid volume (L), extracellular fluid volume (L), plasma volume (L), total body water (L)
Chronic Stress (enzyme linked immunoassays)Before supplementation and after 4 weeks of supplementationSaliva will be analyzed for testosterone, cortisol, uric acid, and c-reactive protein

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026