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New treatment option for Cold Exposure
Official title Energy Dense Fueling for Cold-Weather Operations
ClinicalTrials.gov ID: NCT07489690
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 39. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- Metabolic or cardiovascular abnormalities, gastrointestinal disorders (i.e., kidney disease, diabetes, cardiovascular disease, hypertension etc.)...
- Disease or medication (i.e., diabetes medications, statins, corticosteroids, etc) that affects macronutrient utilization and/or the ability to...
- 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
See the full eligibility 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Natick, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 39 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Natick, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.