Firefighter Thermoregulatory Responses in Active Fire with Betaine Supplementation

NCT ID: NCT06042270

Last Updated: 2024-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-20

Study Completion Date

2024-09-01

Brief Summary

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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

Detailed Description

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Conditions

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Body Temperature Changes Body Water Dehydration Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

10 participants will be given rice-flour as a placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

3 grams per day for \~4 weeks

Betaine

10 participants will be given betaine

Group Type ACTIVE_COMPARATOR

Betaine

Intervention Type DIETARY_SUPPLEMENT

3 grams per day for \~4 weeks

Interventions

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Betaine

3 grams per day for \~4 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

3 grams per day for \~4 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Trimethylglycine Betaine Anhydrous Rice Flour

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Michael J. Ormsbee

OTHER

Sponsor Role lead

Responsible Party

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Michael J. Ormsbee

Director

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Institute of Sports Science and Medicine

Tallahassee, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00004218

Identifier Type: -

Identifier Source: org_study_id

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