Status:
COMPLETED
Influences of Female Sex and Reproductive Hormones on Physiological Aspects of Heat Acclimation
Lead Sponsor:
United States Army Research Institute of Environmental Medicine
Conditions:
Heat Stress, Exertional
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
Women are often understudied in thermal physiology research, leaving recommendations for Soldier safety and performance in hot conditions based largely on data collected in men. Female sex hormones es...
Eligibility Criteria
Inclusion
- • Males and females, age 18-40 y (17 y for active duty military)
- Eumenorrheic females (menstrual cycle length between 24-35 days) or females taking oral contraceptives
- In good health as determined by OMSO (Office of Medical Support and Oversight) General Medical Clearance and willing to report all medications and dietary supplements (i.e. cold medication, Tylenol. Aleve) to the PI and OMSO.
- Passed his/her most recent Army Combat Fitness Test (ACFT) (military volunteers only) or exercise at least 2 times per week (civilian volunteers)
- Willing to not exercise, or drink alcoholic beverages for 24 hours before each testing session
- Willing to not consume caffeine 12 hours prior to any testing sessions
- Willing to refrain from additional moderate to strenuous physical activity throughout testing period
- Males and females with BMI \<30
Exclusion
- • Females who are pregnant or planning to become pregnant during the study
- Females utilizing implantable contraception (intrauterine device, implantable bar)
- Tested positive for COVID-19 within the past 30 days.
- Taking prescription or over the counter medication, other than a contraceptive (unless approved by OMSO and Principal Investigator (PI))
- Tobacco users, or anyone who has used tobacco within the last four months
- Physical problems/injuries that would affect walking or running on a treadmill
- Allergy to skin adhesive
- Heart, lung, kidney, muscle, endocrine, or nerve disorder(s)
- History of heat intolerance or orthostatic intolerance
- Diagnosed and/or treated for fluid/electrolyte imbalance within the last 30 days
- History of obstructive disease of the gastrointestinal tract including (but not limited to) diverticulosis, diverticulitis and inflammatory bowel disease, peptic ulcer disease, Crohn's disease, ulcerative colitis.
- Scheduled MRI during testing
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2024
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT05292170
Start Date
October 1 2021
End Date
April 30 2024
Last Update
August 7 2024
Active Locations (1)
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1
U.S. Army Research Institute of Environmental Medicine
Natick, Massachusetts, United States, 01760