FatigueNCT06172543
The Effects of Nutritional Supplementation on Occupational Performance in Firefighters
A study testing Creatine Monohydrate in people with Fatigue, run by Ward Dobbs at 1 site in United States.
Trial summary
The purpose of this study was to assess the usefulness of protein and carbohydrate supplementation, with and without creatine, on occupational performance in firefighters. Research has examined the effects of adding creatine to whey protein and carbohydrates on training adaptations in resistance-trained individuals… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- Creatine Monohydrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 1 Aug 2023
- 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 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being a firefighter between the ages of 18-55 years of age, and medically cleared for field duty.
Who cannot join
- Any current musculoskeletal or neurological condition that would prohibit the completion of performance testing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Protein and Carbohydrate Supplementation, With and Without Creatine, on Occupational Performance in Firefighters
The purpose of this study was to assess the usefulness of protein and carbohydrate supplementation, with and without creatine, on occupational performance in firefighters. Research has examined the effects of adding creatine to whey protein and carbohydrates on training adaptations in resistance-trained individuals with mixed finding.
Furthermore, the ergogenic benefit of protein and carbohydrate supplementation, with or without creatine, in firefighters is largely unknown. Therefore, the primary aim of the current study was to examine the effects of protein and carbohydrate supplementation, with or without creatine, on occupational performance in firefighters.
- Conditions
- Fatigue
- Being tested
- Creatine Monohydrate, Control
- Keywords
- Creatine
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine MonohydrateDietary supplement
Participants were assigned to ingest a single serving daily of either A) a 25-gram dose of whey protein isolate + 25-gram dose of carbohydrate powder (ProCarb); or B) a 25-gram dose of Whey Protein Isolate + 25-gram dose of carbohydrate powder + 5-gram dose of creatine monohydrate (Creatine) for a 17-21-day period.
ControlDietary supplement
A 25-gram dose of whey protein isolate + 25-gram dose of carbohydrate powder (ProCarb)
| Study group | Role | What they receive |
|---|---|---|
| Creatine Monohydrate Group | Experimental | 25 grams of Whey Protein Isolate + 25 grams of Carbohydrate Powder + 5 grams of Creatine Receives: Dietary Supplement: Creatine Monohydrate |
| Non Creatine Group | Placebo comparator | 25 grams of Whey Protein Isolate + 25 grams of Carbohydrate Powder only Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to completion
Time to completion for tasks including a hose carry, body drag, stair climb, and forcible entry (Keiser sled hammer) for time. For the hose carry, firefighters advanced a 30.48 m section of a charged 4.45 cm hose line over a distance of 30.5 m in a straight line before flowing water for 2 seconds. Rescue consisted of firefighters being instructed to grasp a mannequin (mass 50 kg, height: 180 cm) underneath the shoulders using a "seatbelt" grip and dragging the mannequin 30.5 m backward. This test is known as the body drag. Stair climb consisted of climbing four flights of stairs and returning to the bottom as quickly as possible. In the forcible entry, firefighters struck a simulated forcible entry chopping device (Keiser FORCE Machine, Keiser Co., USA) using a 3.6 kg sledgehammer until completed. The total time to complete each task was recorded, in addition to the total completion time for all tasks summed together.
Measured: 24 Days
Time Trial
A maximal effort, 3.5 km time trial on an air-braked cycle ergometer (Assault Bike, As-sault Fitness Products, Carlsbad, CA, USA).
Measured: 24 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start1 Mar 2023
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ward Dobbs
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, Des Moines University, Lindenwood University
- Responsible party
- Sponsor-investigator, Ward Dobbs, University of Wisconsin, La Crosse
- Investigators
- Andrew Jagim, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172543
- Sponsor's protocol ID
- UWisconsinLaCrosse
- Status last verified
- Dec 2023
- First submitted
- 22 Nov 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Deidentified data is available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Protein and Carbohydrate Supplementation, With and Without Creatine, on Occupational Performance in Firefighters
- ClinicalTrials.gov ID
- NCT06172543
- Acronym / sponsor ID
- UWisconsinLaCrosse
- Conditions
- Fatigue
- Keywords
- Creatine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ward DobbsUniversity, hospital or other
- Collaborators
- Mayo Clinic, Des Moines University, Lindenwood University
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 15 Dec 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 purpose of this study was to assess the usefulness of protein and carbohydrate supplementation, with and without creatine, on occupational performance in firefighters. Research has examined the effects of adding creatine to whey protein and carbohydrates on training adaptations in resistance-trained individuals with mixed finding.
Furthermore, the ergogenic benefit of protein and carbohydrate supplementation, with or without creatine, in firefighters is largely unknown. Therefore, the primary aim of the current study was to examine the effects of protein and carbohydrate supplementation, with or without creatine, on occupational performance in firefighters.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Creatine Monohydrate Group | Experimental | Dietary Supplement: Creatine Monohydrate25 grams of Whey Protein Isolate + 25 grams of Carbohydrate Powder + 5 grams of Creatine |
| Non Creatine Group | Placebo comparator | Dietary Supplement: Control25 grams of Whey Protein Isolate + 25 grams of Carbohydrate Powder only |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Being a firefighter between the ages of 18-55 years of age, and medically cleared for field duty.
Key exclusion criteria (1 listed)
- Any current musculoskeletal or neurological condition that would prohibit the completion of performance testing.
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 |
|---|---|---|
| Creatine MonohydrateParticipants were assigned to ingest a single serving daily of either A) a 25-gram dose of whey protein isolate + 25-gram dose of carbohydrate powder (ProCarb); or B) a 25-gram dose of Whey Protein Isolate + 25-gram dose of carbohydrate powder + 5-gram dose of creatine monohydrate (Creatine) for a 17-21-day period. | Dietary supplement | Creatine Monohydrate Group |
| ControlA 25-gram dose of whey protein isolate + 25-gram dose of carbohydrate powder (ProCarb) | Dietary supplement | Non Creatine Group |
Primary outcome
Time to completion
Time frame: 24 Days
Time to completion for tasks including a hose carry, body drag, stair climb, and forcible entry (Keiser sled hammer) for time. For the hose carry, firefighters advanced a 30.48 m section of a charged 4.45 cm hose line over a distance of 30.5 m in a straight line before flowing water for 2 seconds. Rescue consisted of firefighters being instructed to grasp a mannequin (mass 50 kg, height: 180 cm) underneath the shoulders using a "seatbelt" grip and dragging the mannequin 30.5 m backward. This test is known as the body drag. Stair climb consisted of climbing four flights of stairs and returning to the bottom as quickly as possible. In the forcible entry, firefighters struck a simulated forcible entry chopping device (Keiser FORCE Machine, Keiser Co., USA) using a 3.6 kg sledgehammer until completed. The total time to complete each task was recorded, in addition to the total completion time for all tasks summed together.
Time Trial
Time frame: 24 Days
A maximal effort, 3.5 km time trial on an air-braked cycle ergometer (Assault Bike, As-sault Fitness Products, Carlsbad, CA, USA).
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 15 Dec 2023.
- Individual participant dataSharing planned: Undecided. Deidentified data is available upon request.
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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.
Andrew Jagim, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine Monohydrate in people with Fatigue, run by Ward Dobbs 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 1 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 15 Dec 2023. 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?
Time to completion (time frame: 24 Days). The study lists 2 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 15 Dec 2023.