💬In plain words
What the trial is, and whether it could suit you
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, wi
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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