USARIEM
Natick, Massachusetts, 01760, United States
Location status: Recruiting
NCT Number: NCT07489690
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.
Interested in participating?
Request Info18 year–39 year
All sexes
Interventional
Not applicable
Natick, Massachusetts, 01760, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
• Men and women aged 18 - 39 years (17 if active Military)
Exclusion criteria
Higher FatSupplement Bar
Higher Carbohydrate Supplement Bar
Time frame: 30 minutes
2 mile time trial run
Time frame: 90 minutes
Respiratory Exchange Ratio
Contact information is provided by the study sponsor or research team.
United States Army Research Institute of Environmental Medicine
Fed
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