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

• Sponsor: University of Southern California (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05934708
• Collaborator: (none)
• Enrollment: 30
• Arms: 3
• Anticipated Duration (Months): 12

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Response	Behavioral: Downhill Running	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Health Services Research
• Official Title: Examining the Role of Female Endogenous Sex Hormones in Recovery Following Downhill Running
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: May 1, 2024
• Anticipated Study Completion Date: Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low estrogen; low progesterone Participants will come in while on their period. During this time estrogen and progesterone concentrations are low.	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.
Experimental: High estrogen; low progesterone Participants will come in just before ovulation, when estrogen concentrations are high and progesterone concentrations remain low.	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.
Experimental: Medium estrogen; high progesterone Participants will come in just after ovulation when estrogen concentrations are at a medium level, and progesterone concentrations are high.	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.

Outcome Measures

Primary Outcome Measures

1. Inflammatory markers [Change over time (pre/post, 24 hour, 48 hour)]

   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.

2. Counter movement jump height [Change over time (pre/post, 24 hour, 48 hour)]

   A countermovement jump (CMJ) will be performed on VALD ForceDecks to determine muscle function overtime.

3. Maximal voluntary isometric contraction (MVIC) [Change over time (pre/post, 24 hour, 48 hour)]

   A MVIC will be performed on VALD ForceDecks to determine muscle function overtime.

4. Passive Delayed Onset Muscle Soreness (DOMS) [Change over time (pre/post, 24 hour, 48 hour)]

   DOMS will be assessed as participants are stationary to assess their perception of muscle damage over time.

5. Active Delayed Onset Muscle Soreness (DOMS) [Change over time (pre/post, 24 hour, 48 hour)]

   DOMS will be assessed as participants complete a wall sit to assess their perception of muscle soreness over time.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Southern California

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Todd Schroeder, Professor, University of Southern California
• ClinicalTrials.gov Identifier: NCT05934708
• Other Study ID Numbers: HS-23-00363
• First Posted: Jul 7, 2023
• Last Update Posted: Jul 7, 2023
• Last Verified: Jun 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Todd Schroeder, Professor, University of Southern California: menstrual cycle; exercise

Study Results

No Results Posted as of Jul 7, 2023