NCT07489690

Energy Dense Fueling for Cold-Weather Operations

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: United States Army Research Institute of Environmental Medicine · Federal
• Sex: All
• Age: 18 Years – 39 Years
• Healthy volunteers: Accepted

Summary

High daily energy expenditures without compensatory increases in energy intakes results in severe energy deficits during cold-weather military operations. Observational and experimental data from our laboratory suggests that consuming higher-fat, energy dense products can increase energy intake and attenuate energy deficits, however, laboratory analysis is needed to understand the impact of macronutrient manipulation on substrate oxidation and aerobic performance. This proof of concept, randomized crossover study will examine the effects of consuming an isocaloric bar (approximately 350 kcal) that is higher in carbohydrate (CHO: 50% carbohydrate, 30% fat, 20% protein) or higher in fat (FAT: 30% carbohydrate, 50% fat, 20% protein) on substrate oxidation and aerobic performance (time trial) during acute cold (5°C) exposure. Volunteers will wear shorts and a t-shirt during cold exposure, with continuous monitoring of core and skin temperatures. Baseline data will be collected on volunteer height, weight, body composition, and V̇O2peak. To ensure volunteers are familiar with exercise protocols, they will complete practice sessions of all exercise before the start of data collection. Exercise and diet will be controlled throughout data collection. 24 hours prior to data collection, volunteers will consume a lead-in study diet and will abstain from exercise. After 24 hours, volunteers will return to the laboratory for assessment of substrate oxidation and aerobic performance. Volunteers will consume the CHO or FAT treatment bars under cold conditions, followed by 60 minutes of rest prior to the start of exercise. Volunteers will then complete 90 minutes of load carriage steady-state (55 ± 5% VO2peak) treadmill exercise, wearing a ruck with weighing 30% of their total body mass. After steady-state exercise, aerobic performance will be assessed by having volunteers complete a 2-mile time trial. Indirect calorimetry will be used to determine substrate oxidation during steady-state exercise. Serial blood draws will be collected during each trial to assess circulating substrate/hormone responses. Protocol days will be separated by a minimum washout period of 6 days.

Detailed description

This randomized crossover double blind control study will examine the effects of consuming an isocaloric bar (approximately 350 kcal) that is higher in carbohydrate (CHO: 50% carbohydrate, 30% fat, 20% protein) or higher in fat (FAT: 30% carbohydrate, 50% fat, 20% protein) on substrate oxidation and aerobic performance (time trial) during acute cold (5°C; Climatic Chamber, Natick, MA) exposure. The order of the treatment bar assignments will be randomized. Randomization will be created using a random numbers generator (http://randomization.com or similar). Only a designated study staff member will be unblinded to the code for the treatment bars. Volunteers will wear shorts and a t-shirt for all study procedures. Baseline data will be collected on volunteer height, weight, body composition (dual energy x-ray absorptiometry), and V̇O2peak. To ensure volunteers are familiar with exercise protocols, they will complete practice sessions of all exercise before the start of data collection. Exercise and diet will be controlled throughout data collection. 24 hours prior to data protocol days, volunteers will consume a lead-in study diet and will abstain from exercise. After 24 hours, volunteers will return to the laboratory for assessment of substrate oxidation and aerobic performance. Volunteers will consume the CHO or FAT treatment under cold conditions, followed by a 60 min rest to induced physiological cold responses prior to the start of exercise. Volunteers will then complete 90 min of load carriage (30% body mass) steady-state (55 ± 5% V̇O2peak) treadmill exercise. Indirect calorimetry will be used to determine substrate oxidation during steady-state exercise. Serial blood draws will be collected during each trial to assess circulating substrate/hormone responses. After steady-state exercise, aerobic performance will be assessed by having volunteers complete a 2-mile time trial. There will be a minimum washout period of 6 days.

Conditions

• Cold Exposure

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	High Fat	Higher FatSupplement Bar
DIETARY_SUPPLEMENT	High Carbohydrate	Higher Carbohydrate Supplement Bar

Timeline

• Start date: 2026-02-14
• Primary completion: 2026-07-15
• Completion: 2026-09-30
• First posted: 2026-03-24
• Last updated: 2026-03-24

Locations

1 site across 1 country: United States