- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07822048
Effects of Beef-Forward Ready-to-Eat Meals on Recovery Following Simulated Fire Suppression Activities (FIRE-BEEF)
Effects of Beef-forward Ready-to-eat Meals Before and After Simulated Fire Suppressive Activities on Markers of Cardiometabolic Health, Catabolism, and Recovery: A Pilot Feasibility Study
This clinical trial aims to determine whether consuming beef-based protein before and after physically demanding simulated firefighting activities improves recovery, physical performance, and cognitive performance in healthy adult firefighters. The study will also compare beef-based protein meals with plant-based protein meals.
The main questions this study aims to answer are:
Does consuming beef-based protein reduce changes in markers of muscle damage, physiological stress, and muscle soreness following a simulated fire ground test?
Does consuming beef-based protein help maintain or improve physical and cognitive performance during recovery compared with plant-based protein?
Researchers will compare two ready-to-eat meal conditions: beef-based protein, and plant-based protein. Each participant will complete all two conditions in a randomized crossover design, with 14 to 21 days between conditions.
Přehled studie
Postavení
Podmínky
Detailní popis
Firefighting is a physically and cognitively demanding occupation characterized by repeated exposure to strenuous activity, heat stress, heavy personal protective equipment, and time-sensitive occupational tasks. These demands can produce substantial physiological stress and fatigue that may influence recovery and readiness for subsequent occupational activities. Despite the importance of maintaining readiness between demanding events, relatively little is known about how short-term dietary strategies, particularly protein source and intake, influence recovery in career firefighters.
This study will examine the effects of short-term consumption of ready-to-eat meals (RTEM) differing in protein source and quantity on physiological recovery and occupational performance following strenuous simulated firefighting activity. The study uses a randomized, double-blind, repeated-measures crossover design in healthy adult career firefighters. Participants will complete two experimental conditions separated by a 14- to 21-day washout period. The dietary conditions consist of beef-based protein RTEM and plant-based protein RTEM. The beef- and plant-based conditions are designed to provide comparable energy and macronutrient intake while allowing investigation of potential differences associated with protein source.
During each experimental condition, participants will complete a simulated fire ground test (FGT) consisting of nine occupationally relevant firefighting tasks while wearing personal protective equipment and a self-contained breathing apparatus. The FGT includes hose deployment and pulling, charged hose deployment, equipment carrying, a low-room search, forcible entry, ladder carrying, stair climbing and hose hoisting, ceiling breach activities, and a victim-dummy drag. Measures of FGT completion time, heart rate, air consumption, and work efficiency will be collected to characterize occupational performance and physiological demand.
Recovery will be evaluated before the simulated firefighting activity and during the subsequent recovery period. Assessments will characterize blood-based markers of catabolism, immune stress, muscle damage, and clinical safety, as well as muscle soreness, mood, cognitive function, vertical jump performance, and subsequent occupational performance.
The primary hypothesis is that the beef-based RTEM condition will attenuate catabolic responses, immune stress, muscle damage, soreness, and perceptions of fatigue following the FGT while supporting the maintenance or recovery of cognitive and physical performance. The inclusion of plant-based protein condition will help determine whether recovery responses differ according to dietary protein source and protein quantity.
The findings are intended to provide preliminary evidence regarding practical, food-based nutritional strategies that may support recovery and occupational readiness among firefighters following strenuous firefighting activity.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Drew E Gonzalez, PhD
- Telefonní číslo: 2107888616
- E-mail: drewgonzalez418@shsu.edu
Studijní místa
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Texas
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Fort Worth, Texas, Spojené státy, 76115
- Nábor
- Bob Bolen Public Safety Complex Administration
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Kontakt:
- Drew E Gonzalez, PhD
- Telefonní číslo: 2107888616
- E-mail: drewgonzalez418@shsu.edu
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Dílčí vyšetřovatel:
- Andrew Wolfe, EdD
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Dílčí vyšetřovatel:
- Nick Barringer, PhD
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Dílčí vyšetřovatel:
- Brian Newman, PhD
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Kontakt:
- Brian Newman, PhD
- Telefonní číslo: 360-393-5702
- E-mail: Brian.Newman@fortworthtexas.gov
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Dílčí vyšetřovatel:
- David Church, PhD
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Dílčí vyšetřovatel:
- Austin Garybeal, PhD
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Huntsville, Texas, Spojené státy, 77340
- Nábor
- Sam Houston State University
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Kontakt:
- Drew E Gonzalez, PhD
- Telefonní číslo: 2107888616
- E-mail: drewgonzalez418@shsu.edu
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- 18 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
Exclusion Criteria:
- 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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: Plant-Based Protein Ready-to-Eat Meals
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.
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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.
|
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Experimentální: Beef-Based Protein Ready-to-Eat Meals
Participants will consume beef-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 beef 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.
|
Beef-Based Protein Ready-to-Eat Meals: Participants will consume study-provided ready-to-eat meals (RTEM) in which lean beef 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.
Beef-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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Testosterone and Cortisol
Časové okno: Baseline, 24, 48, and 72 hours following the simulated fire ground test
|
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.
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Baseline, 24, 48, and 72 hours following the simulated fire ground test
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Change in Serum Creatine Kinase
Časové okno: Baseline, 24, 48, and 72 hours following the simulated fire ground test
|
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.
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Baseline, 24, 48, and 72 hours following the simulated fire ground test
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Change in Perceived Muscle Soreness
Časové okno: Pre-fire ground test and 24, 48, and 72 hours of recovery
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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.
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Pre-fire ground test and 24, 48, and 72 hours of recovery
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Fire Ground Test Completion Time
Časové okno: During each simulated fire ground test on Day 1 (baseline) and Day 4 (72 hour mark)
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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.
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During each simulated fire ground test on Day 1 (baseline) and Day 4 (72 hour mark)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Complete Blood Count With Differential
Časové okno: Baseline, 24, 48, and 72 hours following the simulated fire ground test
|
A complete blood count (CBC) with differential will be assessed to characterize hematological responses and monitor clinical safety across the experimental conditions.
Measures will include standard hematological indices and leukocyte differential components reported by the clinical laboratory.
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Baseline, 24, 48, and 72 hours following the simulated fire ground test
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Change in Comprehensive Metabolic Panel
Časové okno: Baseline, 24, 48, and 72 hours following the simulated fire ground test
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A comprehensive metabolic panel (CMP) will be assessed to characterize metabolic responses and monitor clinical safety across the experimental conditions.
Standard CMP components, including markers related to renal and hepatic function, electrolytes, glucose, and protein status, will be evaluated as reported by the clinical laboratory.
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Baseline, 24, 48, and 72 hours following the simulated fire ground test
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Food Satisfaction
Časové okno: At Baseline, 24, 48, and 72 hours
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Participants will report satisfaction with the study-provided ready-to-eat meals to characterize acceptability of each dietary condition.
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At Baseline, 24, 48, and 72 hours
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Heart Rate During the Fire Ground Test
Časové okno: During each simulated fire ground test on Day 1 (baseline) and Day 4 (72 hour mark)
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Heart rate will be monitored during the simulated fire ground test to characterize cardiovascular demand during occupational firefighting activity.
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During each simulated fire ground test on Day 1 (baseline) and Day 4 (72 hour mark)
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Change in Vertical Jump Performance
Časové okno: Pre-fire ground test on Day 1 and Day 4
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Vertical jump performance will be assessed as an indicator of lower-body neuromuscular performance and recovery following the simulated fire ground test.
Performance will be compared across dietary conditions.
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Pre-fire ground test on Day 1 and Day 4
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Frequency and Severity of Adverse Symptoms
Časové okno: At Baseline, 24, 48, and 72 hours
|
Participants will report the frequency and severity of general symptoms or side effects associated with each dietary condition, including gastrointestinal distress, dizziness, and shortness of breath.
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At Baseline, 24, 48, and 72 hours
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Change in Profile of Mood States
Časové okno: Pre-fire ground test and through 24, 48, and 72 hours of recovery
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The Profile of Mood States (POMS) questionnaire will be used to assess changes in mood state and perceived fatigue associated with the simulated fire ground test and subsequent recovery.
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Pre-fire ground test and through 24, 48, and 72 hours of recovery
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Change in Trail Making Test Performance
Časové okno: Pre-fire ground test and through 24, 48, and 72 hours of recovery
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The Trail Making Test (TMT) will be used to assess cognitive performance during recovery from the simulated fire ground test.
Performance will be compared across dietary conditions.
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Pre-fire ground test and through 24, 48, and 72 hours of recovery
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Change in Psychomotor Vigilance Test Performance
Časové okno: Pre-fire ground test and through 24, 48, and 72 hours of recovery
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The Psychomotor Vigilance Test (PVT) will be used to assess sustained attention and reaction-time performance during recovery from the simulated fire ground test.
Performance will be compared across dietary conditions.
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Pre-fire ground test and through 24, 48, and 72 hours of recovery
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Drew E Gonzalez, PhD, Sam Houston State University
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- IRB-2026-110
- 2735 (Jiné číslo grantu/financování: The National Cattlemen's Beef Association)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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