NCT07819565

Brief Summary

The goal of this clinical trial is to learn whether consuming pork-based protein before and after physically demanding simulated firefighting activities can improve recovery, physical performance, and cognitive performance in healthy adult firefighters. The study will also compare pork-based protein meals with plant-based protein meals and a carbohydrate-focused control condition. The main questions this study aims to answer are: Does consuming pork-based protein reduce changes in markers of muscle damage, physiological stress, and muscle soreness following a simulated fire ground test? Does consuming pork-based protein help maintain or improve physical and cognitive performance during recovery compared with plant-based protein and a carbohydrate-focused control condition? Researchers will compare three ready-to-eat meal conditions: pork-based protein, plant-based protein, and a carbohydrate-focused control condition. Each participant will complete all three conditions in a randomized crossover design, with 14 to 21 days between conditions.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Jun 2026Dec 2026

Study Start

First participant enrolled

June 1, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 15, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

September 15, 2026

Status Verified

September 1, 2026

Enrollment Period

6 months

First QC Date

September 8, 2026

Last Update Submit

September 8, 2026

Conditions

Keywords

FirefightersPork ProteinDietary ProteinReady-to-Eat MealsTactical AthletesFireground TestOccupational PerformanceExercise RecoveryMuscle SorenessCognitive Performance

Outcome Measures

Primary Outcomes (4)

  • Change in Testosterone and Cortisol

    Serum testosterone and cortisol concentrations will be measured to characterize anabolic and catabolic hormonal responses following the simulated fire ground test. Changes in testosterone, cortisol, and the testosterone-to-cortisol ratio will be compared across dietary conditions.

    Baseline, 24, 48, and 72 hours following the simulated fire ground test

  • Change in Serum Creatine Kinase

    Serum creatine kinase (CK) concentration will be measured as a marker of muscle damage and recovery following the simulated fire ground test. Changes in CK will be compared across the pork-based protein, plant-based protein, and carbohydrate-focused lower-protein dietary conditions.

    Baseline, 24, 48, and 72 hours following the simulated fire ground test

  • Change in Perceived Muscle Soreness

    Participants will report perceived muscle soreness to characterize subjective recovery following the simulated fire ground test. Muscle soreness responses will be compared across dietary conditions.

    Pre-fire ground test and 24, 48, and 72 hours of recovery

  • Fire Ground Test Completion Time

    Total time required to complete the simulated fire ground test (FGT) will be recorded as a measure of occupational firefighting performance. The FGT consists of standardized firefighting-related tasks performed while wearing personal protective equipment and a self-contained breathing apparatus.

    During each simulated fire ground test on Day 1 (baseline) and Day 4 (72 hour mark)

Secondary Outcomes (5)

  • Change in Complete Blood Count With Differential

    Baseline, 24, 48, and 72 hours following the simulated fire ground test

  • Change in Comprehensive Metabolic Panel

    Baseline, 24, 48, and 72 hours following the simulated fire ground test

  • Food Satisfaction

    At Baseline, 24, 48, and 72 hours

  • Heart Rate During the Fire Ground Test

    During each simulated fire ground test on Day 1 (baseline) and Day 4 (72 hour mark)

  • Change in Vertical Jump Performance

    Pre-fire ground test on Day 1 and Day 4

Other Outcomes (4)

  • Frequency and Severity of Adverse Symptoms

    At Baseline, 24, 48, and 72 hours

  • Change in Profile of Mood States

    Pre-fire ground test and through 24, 48, and 72 hours of recovery

  • Change in Trail Making Test Performance

    Pre-fire ground test and through 24, 48, and 72 hours of recovery

  • +1 more other outcomes

Study Arms (3)

Pork-Based Protein Ready-to-Eat Meals

EXPERIMENTAL

Participants will consume pork-based protein ready-to-eat meals (RTEM) during this experimental condition. Meals will provide approximately 700.- 800 kcal, 80 g carbohydrate, 50 g protein, and 30 g fat per meal, with lean pork serving as the primary protein source. The dietary intervention is designed to provide a total daily protein intake consistent with study targets. Participants will consume the study-provided meals surrounding the simulated fire ground testing and recovery period, with physiological, cognitive, and physical performance outcomes assessed during recovery.

Other: Pork-Based Protein Ready-to-Eat Meals

Plant-Based Protein Ready-to-Eat Meals

ACTIVE COMPARATOR

Participants will consume plant-based protein ready-to-eat meals (RTEM) during this comparator condition. Meals will be designed to approximate the energy and macronutrient content of the pork-based condition, providing approximately 700-800 kcal, 80 g carbohydrate, 50 g protein, and 30 g fat per meal, with plant-based foods such as soy, tempeh, or tofu as the primary protein sources. Participants will consume the study-provided meals surrounding the simulated fire ground testing and recovery period, with the same physiological, cognitive, and physical performance outcomes assessed.

Other: Plant-Based Protein Ready-to-Eat Meals

Carbohydrate-Focused Lower-Protein Control

ACTIVE COMPARATOR

Participants will consume carbohydrate-focused ready-to-eat meals during the control condition. This condition will provide a lower total daily protein intake of approximately 0.8 g/kg/day and will serve as a dietary control for comparison with the higher-protein pork-based and plant-based conditions. Participants will consume the study-provided meals surrounding the simulated fire ground testing and recovery period, with the same physiological, cognitive, and physical performance outcomes assessed.

Other: Carbohydrate-Focused Lower-Protein Ready-to-Eat Meals

Interventions

Pork-Based Protein Ready-to-Eat Meals: Participants will consume study-provided ready-to-eat meals (RTEM) in which lean pork serves as the primary protein source. Meals are designed to provide approximately 700 - 800 kcal, 80 g carbohydrate, 50 g protein, and 30 g fat per meal, with total daily protein intake targeted at approximately 1.4-2.0 g/kg/day. Pork-based meals will be provided during the approximately 3-day experimental period surrounding the simulated fire ground test and subsequent recovery assessments. Meals are designed to match the energy and macronutrient content of the plant-based protein condition.

Pork-Based Protein Ready-to-Eat Meals

Plant-Based Protein Ready-to-Eat Meals: Participants will consume study-provided ready-to-eat meals (RTEM) in which plant-based foods serve as the primary protein source. Plant protein sources may include soy, tempeh, tofu, and other soy-based foods. Meals are designed to provide approximately 700 - 800 kcal, 80 g carbohydrate, 50 g protein, and 30 g fat per meal, with total daily protein intake targeted at approximately 1.4-2.0 g/kg/day. Plant-based meals will be provided during the approximately 3-day experimental period surrounding the simulated fire ground test and subsequent recovery assessments and will be matched as closely as feasible to the pork-based condition for energy and macronutrient content.

Plant-Based Protein Ready-to-Eat Meals

Carbohydrate-Focused Lower-Protein Ready-to-Eat Meals: Participants will consume study-provided carbohydrate-focused ready-to-eat meals (RTEM) designed to provide a lower total daily protein intake of approximately 0.8 g/kg/day. This condition serves as the lower-protein dietary control for comparison with the pork-based and plant-based higher-protein conditions. Meals will be provided during the approximately 3-day experimental period surrounding the simulated fire ground test and subsequent recovery assessments.

Carbohydrate-Focused Lower-Protein Control

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • to 60 years of age
  • Current trained male or female firefighter with the Fort Worth Fire Department
  • Able to comply with all study procedures and the study timeline
  • Willing to consume only the study-provided ready-to-eat meals (RTEM) during designated study periods
  • Willing to refrain from alcohol, nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, and over-the-counter pain medications for 48 hours before testing sessions
  • Available to complete the study visits and required testing procedures

You may not qualify if:

  • Younger than 18 years or older than 60 years
  • Not a current firefighter with the Fort Worth Fire Department
  • Pregnant, breastfeeding, or planning to become pregnant during the study
  • Orthopedic or musculoskeletal limitations that prevent safe completion of the vertical jump or simulated fire ground test
  • Use of weight-loss dietary supplements or medications within the previous 2 weeks
  • Unwilling to refrain from alcohol, NSAIDs, aspirin, or over-the-counter pain medications for 48 hours before testing sessions
  • Unwilling or unable to consume only the study-provided RTEM during designated study periods
  • Heavy smoking, defined as more than 1 pack of cigarettes per day during the previous 3 months
  • Allergy to any of the protein sources or study foods

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bob Bolen Public Safety Complex Administration

Fort Worth, Texas, 76115, United States

RECRUITING

Sam Houston State University

Huntsville, Texas, 77340, United States

RECRUITING

Related Publications (3)

  • Ferrando AA, Wolfe RR, Hirsch KR, Church DD, Kviatkovsky SA, Roberts MD, Stout JR, Gonzalez DE, Sowinski RJ, Kreider RB, Kerksick CM, Burd NA, Pasiakos SM, Ormsbee MJ, Arent SM, Arciero PJ, Campbell BI, VanDusseldorp TA, Jager R, Willoughby DS, Kalman DS, Antonio J. International Society of Sports Nutrition Position Stand: Effects of essential amino acid supplementation on exercise and performance. J Int Soc Sports Nutr. 2023 Dec;20(1):2263409. doi: 10.1080/15502783.2023.2263409. Epub 2023 Oct 6.

    PMID: 37800468BACKGROUND
  • Gonzalez DE, McAllister MJ, Waldman HS, Ferrando AA, Joyce J, Barringer ND, Dawes JJ, Kieffer AJ, Harvey T, Kerksick CM, Stout JR, Ziegenfuss TN, Zapp A, Tartar JL, Heileson JL, VanDusseldorp TA, Kalman DS, Campbell BI, Antonio J, Kreider RB. International society of sports nutrition position stand: tactical athlete nutrition. J Int Soc Sports Nutr. 2022 Jun 23;19(1):267-315. doi: 10.1080/15502783.2022.2086017. eCollection 2022.

    PMID: 35813846BACKGROUND
  • Gonzalez DE, Hines KE, Sowinski RJ, Estes L, Johnson SE, Chun J, Lee H, Leon S, Gil A, Ko J, Broeckel J, Barringer ND, Rasmussen CJ, Kreider RB. Effects of Pork Protein Ingestion Prior to and Following Performing the Army Combat Fitness Test on Markers of Catabolism, Inflammation, and Recovery. Nutrients. 2025 Jun 13;17(12):1995. doi: 10.3390/nu17121995.

    PMID: 40573107BACKGROUND

MeSH Terms

Conditions

Myalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Drew E Gonzalez, PhD

    Sam Houston State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Drew Edward Gonzalez, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Tenure Track Assistant Professor

Study Record Dates

First Submitted

September 8, 2026

First Posted

September 15, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

September 15, 2026

Record last verified: 2026-09

Locations