NCT06172543

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 15, 2023

Completed
Last Updated

December 15, 2023

Status Verified

December 1, 2023

Enrollment Period

5 months

First QC Date

November 22, 2023

Last Update Submit

December 6, 2023

Conditions

Fatigue

Keywords

Creatine

Outcome Measures

Primary Outcomes (2)

  • 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.

    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).

    24 Days

Study Arms (2)

Creatine Monohydrate Group

EXPERIMENTAL

25 grams of Whey Protein Isolate + 25 grams of Carbohydrate Powder + 5 grams of Creatine

Dietary Supplement: Creatine Monohydrate

Non Creatine Group

PLACEBO COMPARATOR

25 grams of Whey Protein Isolate + 25 grams of Carbohydrate Powder only

Dietary Supplement: Control

Interventions

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.

Creatine Monohydrate Group
ControlDIETARY_SUPPLEMENT

A 25-gram dose of whey protein isolate + 25-gram dose of carbohydrate powder (ProCarb)

Non Creatine Group

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being a firefighter between the ages of 18-55 years of age, and medically cleared for field duty.

You may not qualify if:

  • Any current musculoskeletal or neurological condition that would prohibit the completion of performance testing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fire Department

La Crosse, Wisconsin, 54601, United States

Location

MeSH Terms

Conditions

Fatigue

Interventions

Creatine

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Andrew Jagim, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 22, 2023

First Posted

December 15, 2023

Study Start

March 1, 2023

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

December 15, 2023

Record last verified: 2023-12

Locations

US(1)