Energy Dense Fueling for Cold-Weather Operations

United States Army Research Institute of Environmental Medicine

Status: Enrolling

Conditions: Cold Exposure

Treatments: Dietary Supplement: High Fat; Dietary Supplement: High Carbohydrate

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT07489690

25-09H

MO240033 (Other Grant/Funding Number)

Details and patient eligibility

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.

Full 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.

Enrollment: 8 estimated patients

Sex: All

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

8 participants in 2 patient groups, including a placebo group

Higher Fat Supplement Bar

Experimental group

Description:

Higher Fat, then High Carbohydrate

Treatment:

Dietary Supplement: High Fat

Higher Carbohydrate Supplement Bar

Placebo Comparator group

Description:

High Carbohydrate, then High Fat

Treatment:

Dietary Supplement: High Carbohydrate