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Clinical Trial NCT07489690 for Cold Exposure is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Energy Dense Fueling for Cold-Weather Operations 8 Randomized Crossover Design Observational Dietary

Recruiting
Clinical Trial NCT07489690 is an interventional study for Cold Exposure that is recruiting. It started on 14 February 2026 with plans to enroll 8 participants. Led by United States Army Research Institute of Environmental Medicine, it is expected to complete by 30 September 2026. The latest data from ClinicalTrials.gov was last updated on 24 March 2026.
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...Show More
Detailed 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 trea...

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Official Title

Energy Dense Fueling for Cold-Weather Operations

Conditions
Cold Exposure
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • 25-09H
  • MO240033 (Other Grant/Funding Number) (MRDC)
NCT ID Number
NCT07489690
Start Date (Actual)
2026-02-14
Last Update Posted
2026-03-24
Completion Date (Estimated)
2026-09-30
Enrollment (Estimated)
8
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
endurance exercise
dietary fat
dietary carbohydrate
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalHigher Fat Supplement Bar
Higher Fat, then High Carbohydrate
High Fat
Higher FatSupplement Bar
Placebo ComparatorHigher Carbohydrate Supplement Bar
High Carbohydrate, then High Fat
High Carbohydrate
Higher Carbohydrate Supplement Bar
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Endurance Performance
2 mile time trial run
30 minutes
Substrate Oxidation
Respiratory Exchange Ratio
90 minutes
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes

• 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)

  • 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
United States Army Research Institute of Environmental Medicine logoUnited States Army Research Institute of Environmental Medicine
Study Central Contact
Contact: USARIEM Recruitment, 508-206-2278, [email protected]
1 Study Locations in 1 Countries

Massachusetts

USARIEM, Natick, Massachusetts, 01760, United States
Michael A Dawson, PhD, Contact, 508-206-2278, [email protected]
Recruiting