Menstrual Cycle Phase Muscle Protein Synthesis

Influence of Menstrual Cycle Phase on the Muscle Protein Synthetic Response to Exercise in Young, Healthy, Naturally Cycling Women

Skeletal muscle size and function is regulated by various factors, including hormones. While we understand the role of male sex hormones (testosterone), we aren't sure how female sex hormones (estrogen and progesterone) influence muscle mass and strength. Female physiology is unique in that hormones fluctuate throughout the menstrual cycle. In the first phase (follicular phase) following menstruation, estrogen levels are high while progesterone levels are low. In the second phase (luteal phase), progesterone levels are high. Females are often excluded from studies because researchers are concerned that the menstrual cycle might affect the results. The purpose of this study is to investigate the response to resistance exercise in each phase of the menstrual cycle.

Study Overview

• Status: Active, not recruiting
• Conditions: Muscle Protein Synthesis; Menstrual Cycle; Resistance Exercise
• Intervention / Treatment: Other: Unilateral Resistance Exercise Leg; Other: Control Leg

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4K1
      • Exercise Metabolism Research Laboratory, McMaster Univeristy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy females, between the ages of 18 and 30 y with a regular menstrual cycle
• Body Mass Index between 18.5 and 30.0 kg/m2
• Able and willing to provide informed consent

Exclusion Criteria:

• A history of neuromuscular disorders or muscle/bone wasting diseases
• Any acute or chronic illness, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension, insulin-dependent or insulin-independent diabetes, or the presence of any other metabolic disease - all of which will be determined via a medical history screening questionnaire
• The use of any medications known to affect protein metabolism (glucocorticoids, non-steroidal anti-inflammatory medication, or prescription strength acne medication, etc.)
• A (family) history of thrombosis
• The use of anticoagulant medications
• Consumption of tobacco-containing products
• Excessive alcohol consumption (>21 units/wk)
• History of bleeding diathesis, platelet or coagulation disorders
• Currently pregnant
• The use of hormonal contraceptives
• Irregular menstrual cycle

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pre-Ovulation Unilateral Resistance Exercise; One leg will undergo 2 sessions of unilateral resistance exercise during the follicular phase of the menstrual cycle (pre-ovulation).	Other: Unilateral Resistance Exercise Leg; One leg will perform unilateral resistance exercise; Other: Control Leg; One leg will serve as a non-exercise control
Experimental: Post-Ovulation Unilateral Resistance Exercise; One leg will undergo 2 sessions of unilateral resistance exercise during the luteal phase of the menstrual cycle (post-ovulation).	Other: Unilateral Resistance Exercise Leg; One leg will perform unilateral resistance exercise; Other: Control Leg; One leg will serve as a non-exercise control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Rates of Muscle Protein Synthesis	The investigators will use deuterated water and skeletal muscle biopsies to calculate the synthesis of skeletal muscle proteins.	6 days

Collaborators and Investigators

• Sponsor: McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): March 1, 2023
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 26, 2022

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 14067

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All participants will be assigned a unique subject ID, and therefore, other researchers involved with analyses will not have access to identifying participant information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No