Actively Recruiting

Phase Not Applicable
Age: 18Years - 39Years
All Genders
Healthy Volunteers
NCT07489690

Energy Dense Fueling for Cold-Weather Operations

Led by United States Army Research Institute of Environmental Medicine · Updated on 2026-03-24

8

Participants Needed

1

Research Sites

32 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Energy Dense Fueling for Cold-Weather Operations

Who Can Participate

Age: 18Years - 39Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women aged 18 to 39 years (17 if active military)
  • Physically active, exercising at least 2 days per week
  • Have supervisor approval if permanent party military or civilians at NSSC
  • Willing to avoid alcohol, nicotine products, and dietary supplements during study diets
  • Females with normal menstrual cycles (26-32 days) or using continuous low-dose hormonal contraceptives
  • Only consume caffeine products provided by study staff during study diets
  • Body mass index (BMI) between 18.5 and 30 kg/m2
  • In good health as determined by Office of Medical Support and Oversight (OMSO)
Not Eligible

You will not qualify if you...

  • Metabolic, cardiovascular, or gastrointestinal disorders unsuitable for study as determined by OMSO
  • Diseases or medications affecting macronutrient use or ability to exercise strenuously
  • Food allergies or intolerances, including lactose intolerance or milk allergy, and vegetarian practices
  • Current alcoholism, anabolic steroid use, or other substance abuse issues
  • Unwillingness to stop nutritional or sports supplements during the study
  • Sensitivity to medical adhesives causing significant skin irritation
  • Acute or chronic musculoskeletal injuries limiting running or ruck marching
  • History of gastrointestinal diseases or surgeries
  • Difficulty swallowing large pills or unwillingness to use rectal temperature sensor
  • Raynaud's syndrome
  • History of cold injuries like frostbite or chilblains
  • Cold-induced bronchospasms or asthma
  • Blood donation within 8 weeks before the study
  • Unwillingness or inability to follow study exercise restrictions
  • Scheduled MRI within 2 weeks after completing cold test

AI-Screening

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Trial Site Locations

Total: 1 location

1

USARIEM

Natick, Massachusetts, United States, 01760

Actively Recruiting

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Research Team

U

USARIEM Recruitment

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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