Natick, MANCT07489690Now EnrollingIRB Ready

Cold Exposure Clinical Trial in Natick, MA

Access cutting-edge cold exposure treatment through this clinical trial at a research site in Natick. Study-provided care at no cost to qualified participants.

Sponsored by United States Army Research Institute of Environmental Medicine

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Expert Care in Natick

Access cold exposure specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related cold exposure treatment provided free

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Check if you qualify for this cold exposure clinical trial in Natick, MA

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Natick

    Convenient for MA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Natick site if eligible
  4. 4Begin participation

About This Cold Exposure Study in Natick

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.

Sponsor: United States Army Research Institute of Environmental Medicine

Who Can Participate

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Natick?

Yes, this clinical trial (NCT07489690) has an active research site in Natick, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Cold Exposure Treatment Options in Natick, MA

If you're searching for cold exposure treatment options in Natick, MA, this clinical trial (NCT07489690) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Natick research site is actively enrolling participants for this clinical trial. You'll receive care from experienced cold exposure specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all cold exposure clinical trials near you to find additional studies recruiting in your area.

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