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Influences of Female Sex and Reproductive Hormones on Physiological Aspects of Heat Acclimation

Influences of Female Sex and Reproductive Hormones on Physiological Aspects of Heat Acclimation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05292170
Enrollment
27
Registered
2022-03-23
Start date
2021-10-01
Completion date
2024-04-30
Last updated
2024-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heat Stress, Exertional

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 estradiol and progesterone clearly have non-reproductive physiological effects, including influences on thermoregulatory and cardiovascular function. However, mechanisms of differing physiological adaptations to repeated heat exposure (i.e., heat acclimation) as a function of reproductive hormone status have yet to be investigated in a systematic way. Understanding possible sex differences in adaptation or mechanisms for adaptation during heat acclimation is important to ultimately optimize interventions to maximize soldier health and safety during training and deployment in the heat. Our goals in the present study are to evaluate physiological and biophysical responses to a standard heat acclimation protocol in a group of young, healthy men and women. Thirty individuals (n=10 males, n=10 women with a low hormonal status (i.e. early follicular phase), n=10 women with a high hormonal status (i.e. midluteal phase)) will complete 10 consecutive days of exercise (treadmill walking: 3.1 mph/2% grade) in the heat (40°C /40% relative humidity) up to 3hr per day. Changes in core temperature, heart rate, and sex hormones will be assessed to examine differences in thermoregulatory response to heat acclimation.

Interventions

10 consecutive days of heat acclimation

Sponsors

United States Army Research Institute of Environmental Medicine
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* • 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 criteria

* • 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

Design outcomes

Primary

MeasureTime frame
Core temperature10 days
Heart rate10 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026