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

Thermoregulatory Responses of Betaine Supplementation in Firefighters During Live Burn

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

Study Overview

• Status: Active, not recruiting
• Conditions: Inflammation; Body Temperature Changes; Body Water Dehydration
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Betaine

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liliana Renteria; Phone Number: 8506451016; Email: lir20@fsu.edu
• Study Contact Backup: Name: Michael Ormsbee, PhD; Email: mormsbee@fsu.edu

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Michael J. Ormsbee

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2023
• Primary Completion (Actual): March 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: August 25, 2023
• First Submitted That Met QC Criteria: September 11, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Water-Electrolyte Imbalance; Inflammation; Dehydration; Body Temperature Changes; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Gastrointestinal Agents; Hypolipidemic Agents; Lipid Regulating Agents; Lipotropic Agents; Betaine
• Other Study ID Numbers: STUDY00004218

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No