Firefighter Thermoregulatory Responses in Active Fire with Betaine Supplementation

NCT06042270 | Completed

• 1 other identifier: STUDY00004218
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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

Conditions

Body Temperature Changes; Body Water Dehydration; Inflammation

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Chronic Stress (enzyme linked immunoassays)

  Before supplementation and after 4 weeks of supplementation

• Chronic Stress (vitals) professional firefighters.

  Before supplementation and after 4 weeks of supplementation

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

  Before supplementation and after 4 weeks of supplementation

Study Arms (2)

Placebo

PLACEBO COMPARATOR

10 participants will be given rice-flour as a placebo

Dietary Supplement: Placebo

Betaine

ACTIVE COMPARATOR

10 participants will be given betaine

Dietary Supplement: Betaine

Interventions

Betaine DIETARY_SUPPLEMENT

3 grams per day for \~4 weeks

Also known as: Trimethylglycine, Betaine Anhydrous

Betaine

Placebo DIETARY_SUPPLEMENT

3 grams per day for \~4 weeks

Also known as: Rice Flour

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Structural Firefighter

You may not qualify if:

• 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

Sponsors & Collaborators

• Michael J. Ormsbee: lead

Study Sites (1)

Institute of Sports Science and Medicine

Tallahassee, Florida, 32301, United States

Location

MeSH Terms

Conditions

Body Temperature Changes; Dehydration; Inflammation

Interventions

Betaine; Flour

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: September 18, 2023
• Study Start: December 20, 2023
• Primary Completion: March 1, 2024
• Study Completion: September 1, 2024
• Last Updated: October 17, 2024

Record last verified: 2024-04

Locations

US (1)