Body Temperature ChangesFFBETNCT06042270
Firefighter Thermoregulatory Responses in Active Fire with Betaine Supplementation
A study testing Betaine in people with Body Temperature Changes and Body Water Dehydration, run by Michael J. Ormsbee at 1 site in United States.
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?… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Body Temperature Changes, Body Water Dehydration, Inflammation
- What is being tested?
- Betaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2023to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Structural Firefighter
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute of Sports Science and Medicine
Tallahassee, Florida, 32301
About this study
Official title: 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
- Being tested
- Betaine, Placebo
- Medical subject headings
- Body Temperature Changes, Dehydration, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetaineDietary supplement
Also called Trimethylglycine, Betaine Anhydrous
3 grams per day for ~4 weeks
PlaceboDietary supplement
Also called Rice Flour
3 grams per day for ~4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 10 participants will be given rice-flour as a placebo Receives: Dietary Supplement: Placebo |
| Betaine | Active comparator | 10 participants will be given betaine Receives: Dietary Supplement: Betaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thermoregulation
Core temperature (Degrees C), skin temperature (Degrees C)
Measured: 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.
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
Measured: 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
Measured: 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.
Measured: 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
Measured: immediately before and immediately after the completion of the live burn
Secondary outcomes (3)
Chronic Stress (enzyme linked immunoassays)
Saliva will be analyzed for testosterone, cortisol, uric acid, and c-reactive protein
Measured: 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.
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)
Measured: Before supplementation and after 4 weeks of supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start20 Dec 2023
- Primary completion1 Mar 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Temperature ChangesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael J. Ormsbee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael J. Ormsbee, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042270
- Sponsor's protocol ID
- STUDY00004218
- Acronym
- FFBET
- Status last verified
- Apr 2024
- First submitted
- 25 Aug 2023
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermoregulatory Responses of Betaine Supplementation in Firefighters During Live Burn
- ClinicalTrials.gov ID
- NCT06042270
- Acronym / sponsor ID
- FFBET / STUDY00004218
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Michael J. OrmsbeeUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo10 participants will be given rice-flour as a placebo |
| Betaine | Active comparator | Dietary Supplement: Betaine10 participants will be given betaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Structural Firefighter
Key exclusion criteria (7 listed)
- • Participants have a cardiometabolic disease for which they take prescribed medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BetaineAlso: Trimethylglycine, Betaine Anhydrous3 grams per day for ~4 weeks | Dietary supplement | Betaine |
| PlaceboAlso: Rice Flour3 grams per day for ~4 weeks | Dietary supplement | Placebo |
Primary outcome
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)
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.
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
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
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.
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
3 secondary outcomes
Chronic Stress (enzyme linked immunoassays)
Time frame: Before supplementation and after 4 weeks of supplementation
Chronic Stress (vitals) professional firefighters.
Time frame: Before supplementation and after 4 weeks of supplementation
Fluid Compartment Volumes (Bioelectrical Impedance Spectrocopy) professional firefighters.
Time frame: Before supplementation and after 4 weeks of supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Betaine in people with Body Temperature Changes and Body Water Dehydration, run by Michael J. Ormsbee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thermoregulation (time frame: 10 minutes before the live burn, during the ~15 minute live burn, 10, 20, and 30 minutes after the live burn.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.