Recruiting

CHO & FAT

Sponsor:

United States Army Research Institute of Environmental Medicine

Code:

NCT07489690

Conditions

Cold Exposure

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Accepted

Interventions

High Fat

High Carbohydrate

Study Details

Brief 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.

Conditions

Cold Exposure

Study ID

NCT07489690

Start date

Feb 14, 2026

Status verified date

Feb, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Jul 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Accepted

Inclusion Criteria: • Men and women aged 18 - 39 years (17 if active Military)

  • Physically active (exercise minimum 2 days per week)
  • Have supervisor approval (permanent party military and civilians at NSSC)
  • Willing to refrain from alcohol, nicotine products and dietary supplement use while on study diets
  • Females must have normal menstrual cycles between 26-32 days in duration; 5 menstrual cycles within the past 6 months; or using oral/hormonal contraceptive which contains low-dose estrogen/progesterone to maintain continuous levels throughout the 28-day cycle (i.e., no placebos)
  • Only consume caffeine products while on study diets if provided by study staff
  • Body mass index (BMI) between 18.5-30 kg/m2
  • In good health as determined by OMSO (Office of Medical Support and Oversight)

Exclusion Criteria:

  • Metabolic or cardiovascular abnormalities, gastrointestinal disorders (i.e., kidney disease, diabetes, cardiovascular disease, hypertension etc.) that is unsuitable for the study determined by OMSO
  • Disease or medication (i.e., diabetes medications, statins, corticosteroids, etc) that affects macronutrient utilization and/or the ability to participate in strenuous exercise
  • Allergies or intolerance to foods (including but not limited to lactose intolerance/milk allergy), vegetarian practices
  • Present condition of alcoholism, anabolic steroids (testosterone, enanthate, undecanoate, etc), or other substance abuse issues
  • Unwilling to stop use of nutritional/sports supplements (creatine, multivitamins, whey etc.) while enrolled in the study
  • Sensitivity to medical adhesives resulting in significant skin irritation
  • Acute or chronic musculoskeletal injury that compromises the ability to run and ruck march
  • History of disease of the gastrointestinal tract including (but not limited to) diverticulosis, diverticulitis and inflammatory bowel disease, peptic ulcer disease, Crohn's disease, ulcerative colitis; or previous gastrointestinal surgery
  • Difficulty swallowing large pills or unwilling to insert rectal temperature sensor
  • Raynaud's syndrome.
  • History of cold injuries of any severity (e.g., frostbite, trench foot, chilblains) that puts the volunteers at increased risk for an adverse effect
  • Cold-induced bronchospasms/asthma
  • Blood donation within 8 weeks of the study
  • Unwillingness or inability to adhere to study exercise restrictions
  • Scheduled MRI within 2 weeks after completing test in cold

Study Design

Enrollment

8 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Higher Fat Supplement Bar

Higher Fat, then High Carbohydrate

placebo comparator: Higher Carbohydrate Supplement Bar

High Carbohydrate, then High Fat

Interventions

High Fat

Higher FatSupplement Bar

High Carbohydrate

Higher Carbohydrate Supplement Bar

Primary outcome measure

  • Endurance Performance [ Time Frame: 30 minutes ]
  • Substrate Oxidation [ Time Frame: 90 minutes ]

Central Contacts and Locations

Central contacts

Locations

USARIEM

Recruiting

Natick, Massachusetts, United States, 01760

Contacts

More Information

Sponsor

United States Army Research Institute of Environmental Medicine

Last update posted

Mar 24, 2026

Last verified

Feb, 2026

Keywords

  • endurance exercise
  • dietary fat
  • dietary carbohydrate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by United States Army Research Institute of Environmental Medicine on 2026-03-24.