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OpenTrials
Completed

NCT Number: NCT06042270

Firefighter Thermoregulatory Responses in Active Fire with Betaine Supplementation

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

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Key information

Conditions

Body Temperature Changes Body Water Dehydration Dehydration Inflammation Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Sports Science and Medicine

Tallahassee, Florida, 32301, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Betaine

Dietary Supplement

3 grams per day for ~4 weeks

Other names: Trimethylglycine, Betaine Anhydrous

Placebo

Dietary Supplement

3 grams per day for ~4 weeks

Other names: Rice Flour

Primary outcomes

  1. Thermoregulation

    Time frame: 10 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)

  2. Stress (enzyme linked immunoassays)

    Time frame: before, immediately after, 10 minutes, and 20 minutes after live burn

    Salivary expression of Testosterone, Cortisol, interleukin-8, and interleukin 6 will be measured.

  3. Stress (respiration efficiency)

    Time frame: immediately before and immediately after the completion of the live burn

    Air tank pounds per square inch (PSI) will be recorded

  4. Sweat Rate

    Time frame: immediately before and immediately after the completion of the live burn

    Changes in body weight in kg will be used to find loss of sweat in L

  5. Sweat Content

    Time frame: immediately before and immediately after the completion of the live burn

    Tegaderm patches will be worn during the live burn to analyze sodium concentration in sweat.

  6. Subjective measures

    Time frame: immediately before and immediately after the completion of the live burn

    Visual analog scales will be given to participants for subjective thermal sensation, rate of perceived exertion, and thirst

Secondary outcomes

  1. Chronic Stress (enzyme linked immunoassays)

    Time frame: Before supplementation and after 4 weeks of supplementation

    Saliva will be analyzed for testosterone, cortisol, uric acid, and c-reactive protein

  2. Chronic Stress (vitals) professional firefighters.

    Time frame: Before supplementation and after 4 weeks of supplementation

    Resting blood pressure in mmHg and heart rate in beats per minute will be measured.

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

    Time frame: Before supplementation and after 4 weeks of supplementation

    Intracellular fluid volume (L), extracellular fluid volume (L), plasma volume (L), total body water (L)

Sponsors and collaborators

Lead sponsor

Michael J. Ormsbee

Other

Registry information

Official study title

Thermoregulatory Responses of Betaine Supplementation in Firefighters During Live Burn

Acronym: FFBET

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 18, 2023
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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