Firefighter Thermoregulatory Responses in Active Fire With Betaine Supplementation

Inflammation Clinical Trial

— FFBET  

Official title:

Thermoregulatory Responses of Betaine Supplementation in Firefighters During Live Burn

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06042270
• Other study ID #: STUDY00004218
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 20, 2023
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 17
• Est. completion date: September 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Temperature Changes
• Body Water Dehydration
• Dehydration
• Inflammation

Intervention

Dietary Supplement:
• Betaine
3 grams per day for ~4 weeks
• Placebo
3 grams per day for ~4 weeks

Locations

Country	Name	City	State
United States	Institute of Sports Science and Medicine	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Michael J. Ormsbee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	Stress (respiration efficiency)	Air tank pounds per square inch (PSI) will be recorded	immediately before and immediately after the completion of the live burn
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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