Energy Dense Fueling for Cold-Weather Operations
Part of paid clinical trials in Natick, Massachusetts.
- Sponsor
- United States Army Research Institute of Environmental Medicine
- Study ID
- NCT07489690
- Status
- Recruiting
Conditions
- Cold Exposure
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 39 Years
- Healthy Volunteers
- Accepted
Interventions
- High Fat — DIETARY_SUPPLEMENTHigher FatSupplement Bar
- High Carbohydrate — DIETARY_SUPPLEMENTHigher Carbohydrate Supplement Bar
Study Details
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.
Key Dates
- Start date
- Feb 14, 2026
- Status verified
- Feb 2026
- Primary completion
- Jul 15, 2026
- Completion
- Sep 30, 2026
Study Design
- Enrollment
- 8 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Experimental: Higher Fat Supplement BarHigher Fat, then High Carbohydrate
- Placebo Comparator: Higher Carbohydrate Supplement BarHigh Carbohydrate, then High Fat
Primary Outcome Measure
Endurance Performance [ Time Frame: 30 minutes ]
Central Contacts
- USARIEM Recruitment508-206-2278
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| USARIEM | Natick | Massachusetts | 01760 |
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