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_SUPPLEMENT
    Higher FatSupplement Bar
  • High Carbohydrate — DIETARY_SUPPLEMENT
    Higher 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 Bar
    Higher Fat, then High Carbohydrate
  • Placebo Comparator: Higher Carbohydrate Supplement Bar
    High Carbohydrate, then High Fat

Primary Outcome Measure

Endurance Performance [ Time Frame: 30 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
USARIEMNatickMassachusetts01760
Michael A Dawson, PhD
508-206-2278

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