Examining the Role of Female Endogenous Sex Hormones in Recovery Following Downhill Running

Inflammatory Response Clinical Trial

Official title:

Examining the Role of Female Endogenous Sex Hormones in Recovery Following Downhill Running

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05934708
• Other study ID #: HS-23-00363
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: August 2025

Study information

• Verified date: October 2023
• Source: University of Southern California
• Contact: Bailey McLagan, MS
• Phone: 3234422180
• Email: mclagan[@]usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The fluctuating concentrations of female sex hormones, namely estrogen and progesterone may have an effect on the ability of the tissue to withstand challenging exercise conditions, such as eccentric exercise. Namely, estrogen has been known to provide membrane stabilization and antioxidant conditions to tissues. This study aims to uncover how the different estrogen concentrations (high, medium, and low) present in 3 phases of the menstrual cycle affect inflammatory conditions and perception of muscle damage (i.e., DOMS) in those that participate in a downhill running protocol.

Description:

Although nearly half of the population is female, less than 10% of research resources are allocated to understanding how their dynamic physiology impacts athletic readiness, performance, and recovery. The fluctuating concentrations of female sex hormones, namely estrogen and progesterone may have an effect on the ability of the tissue to withstand challenging exercise conditions, such as eccentric exercise. Namely, estrogen has been known to provide membrane stabilization and antioxidant conditions to tissues. This study aims to uncover how the different estrogen concentrations (high, medium, and low) present in 3 phases of the menstrual cycle affect inflammatory conditions and perception of muscle damage (i.e., DOMS) in those that participate in a downhill running protocol.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• 18-35 years of age

• BMI of 18.5-29.9 as a BMI below or above these cut points results in highly varied menstrual cycle lengths [15]

• Not taking contraception or other types of medication that could influence reproductive status

• Regular menstruation

• Non-pregnant

• Medically free from chronic diseases

• Novel to downhill running

• Weight greater than or equal to 110 lbs

• Not taking exogenous hormones

• Not suffering from known gynecological disease (i.e., PCOS, endometriosis, etc.) that may influence menstrual cycle regularity

Exclusion Criteria:

• Amenorrhea or oligomenorrhea

• Perimenopausal or menopausal

• Recreational or professional trail or downhill runner

• On a form of contraception

• Cardiac disability

• Pacemaker

• Arterial disease

• Uncontrolled hemorrhage

• Blood clots

• Pregnant or trying to become pregnant

• Cancerous lesions

• Sensory or mental impairment

• Unstable fractures

• Weight less than 110 lbs

• Suffering from gynecological disease (i.e., PCOS, endometriosis, etc.) that may influence menstrual cycle regularity

• Taking exogenous hormones

Related Conditions & MeSH terms

• Inflammatory Response

Intervention

Behavioral:
• Downhill Running
Participants will complete a 20 minute downhill running protocol on a -12% grade, at ~6 mph. Before the running protocol a baseline blood sample will be collected, as well as passive and active delayed onset muscle soreness (DOMS), a countermovement jump and maximal voluntary isometric contraction. After the running protocol, the same tests will be performed again. The metrics will be collected a third and fourth time at 24 hours and 48 hours post exercise, respectively.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

References & Publications (1)

Oosthuyse T, Bosch AN. The Effect of Gender and Menstrual Phase on Serum Creatine Kinase Activity and Muscle Soreness Following Downhill Running. Antioxidants (Basel). 2017 Feb 23;6(1):16. doi: 10.3390/antiox6010016. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory markers	Inflammatory markers (IL-6, IL-8, TNF-alpha, and Prostaglandin E2) will be measured in blood serum to understand how the concentration of estrogen changes the inflammatory response to damaging exercise.	Change over time (pre/post, 24 hour, 48 hour)
Primary	Counter movement jump height	A countermovement jump (CMJ) will be performed on VALD ForceDecks to determine muscle function overtime.	Change over time (pre/post, 24 hour, 48 hour)
Primary	Maximal voluntary isometric contraction (MVIC)	A MVIC will be performed on VALD ForceDecks to determine muscle function overtime.	Change over time (pre/post, 24 hour, 48 hour)
Primary	Passive Delayed Onset Muscle Soreness (DOMS)	DOMS will be assessed as participants are stationary to assess their perception of muscle damage over time.	Change over time (pre/post, 24 hour, 48 hour)
Primary	Active Delayed Onset Muscle Soreness (DOMS)	DOMS will be assessed as participants complete a wall sit to assess their perception of muscle soreness over time.	Change over time (pre/post, 24 hour, 48 hour)