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

NCT05292170 | Completed

• 1 other identifier: 21-07Hc
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Heat Stress, Exertional

Outcome Measures

Primary Outcomes (2)

• Core temperature

  10 days

• Heart rate

  10 days

Study Arms (3)

Males

EXPERIMENTAL

10 consecutive day heat acclimation in males

Other: Heat acclimation

Females + high hormones

EXPERIMENTAL

10 consecutive day heat acclimation in females with high hormonal dose

Other: Heat acclimation

Females + low hormones

EXPERIMENTAL

10 consecutive day heat acclimation in females with low hormonal dose

Other: Heat acclimation

Interventions

Heat acclimation OTHER

10 consecutive days of heat acclimation

Females + high hormones; Females + low hormones; Males

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Cis gender males and females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• United States Army Research Institute of Environmental Medicine: lead

Study Sites (1)

U.S. Army Research Institute of Environmental Medicine

Natick, Massachusetts, 01760, United States

Location

MeSH Terms

Conditions

Heat Stress Disorders

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: March 23, 2022
• Study Start: October 1, 2021
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

US (1)