Firefighter Thermoregulatory Responses in Active Fire With Betaine Supplementation

Study Overview
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Brief Summary
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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

Official Title
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Thermoregulatory Responses of Betaine Supplementation in Firefighters During Live Burn

Conditions
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Body Temperature Changes, Body Water Dehydration, Inflammation

Intervention / Treatment
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* Dietary Supplement: Betaine
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>10 participants will be given rice-flour as a placebo | Dietary Supplement: Placebo<br>* 3 grams per day for  4 weeks<br>* Other names: Rice Flour;|
| Active Comparator: Betaine<br>10 participants will be given betaine | Dietary Supplement: Betaine<br>* 3 grams per day for  4 weeks<br>* Other names: Betaine Anhydrous;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thermoregulation | Core temperature (Degrees C), skin temperature (Degrees C) | 10 minutes before the live burn, during the  15 minute live burn, 10, 20, and 30 minutes after the live burn. | 
| Stress (enzyme linked immunoassays) | Salivary expression of Testosterone, Cortisol, interleukin-8, and interleukin 6 will be measured. | before, immediately after, 10 minutes, and 20 minutes after live burn | 
| Stress (respiration efficiency) | Air tank pounds per square inch (PSI) will be recorded | immediately before and immediately after the completion of the live burn | 
| Sweat Rate | Changes in body weight in kg will be used to find loss of sweat in L | immediately before and immediately after the completion of the live burn | 
| Sweat Content | Tegaderm patches will be worn during the live burn to analyze sodium concentration in sweat. | immediately before and immediately after the completion of the live burn | 
| Subjective measures | Visual analog scales will be given to participants for subjective thermal sensation, rate of perceived exertion, and thirst | immediately before and immediately after the completion of the live burn | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic Stress (enzyme linked immunoassays) | Saliva will be analyzed for testosterone, cortisol, uric acid, and c-reactive protein | Before supplementation and after 4 weeks of supplementation | 
| Chronic Stress (vitals) professional firefighters. | Resting blood pressure in mmHg and heart rate in beats per minute will be measured. | Before supplementation and after 4 weeks of supplementation | 
| Fluid Compartment Volumes (Bioelectrical Impedance Spectrocopy) professional firefighters. | Intracellular fluid volume (L), extracellular fluid volume (L), plasma volume (L), total body water (L) | Before supplementation and after 4 weeks of supplementation |