Menstrual Cycle Phase and Oral Contraceptive Pill (OCP) Use on Muscle Protein Synthesis

NCT05347667 | Completed

• 1 other identifier: 14067
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Menstrual Cycle; Resistance Exercise; Muscle Protein Synthesis; OCP

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Whole-body proteolysis

  6 days

Study Arms (2)

Pre-Ovulation Unilateral Resistance Exercise OR Active OCP Phase

EXPERIMENTAL

One leg will undergo 2 sessions of unilateral resistance exercise during the follicular phase of the menstrual cycle (pre-ovulation) OR during the active phase of taking the OCP

Other: Unilateral Resistance Exercise Leg; Other: Control Leg

Post-Ovulation Unilateral Resistance Exercise OR Inactive OCP Phase

EXPERIMENTAL

One leg will undergo 2 sessions of unilateral resistance exercise during the luteal phase of the menstrual cycle (post-ovulation) OR during the inactive phase of taking the OCP

Other: Unilateral Resistance Exercise Leg; Other: Control Leg

Interventions

Unilateral Resistance Exercise Leg OTHER

One leg will perform unilateral resistance exercise

Post-Ovulation Unilateral Resistance Exercise OR Inactive OCP Phase; Pre-Ovulation Unilateral Resistance Exercise OR Active OCP Phase

Control Leg OTHER

One leg will serve as a non-exercise control

Post-Ovulation Unilateral Resistance Exercise OR Inactive OCP Phase; Pre-Ovulation Unilateral Resistance Exercise OR Active OCP Phase

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Irregular menstrual cycle as defined in the study protocol

Sponsors & Collaborators

• McMaster University: lead
• Natural Science and Engineering Research Council of Canada (NSERC): collaborator

Study Sites (1)

Exercise Metabolism Research Laboratory, McMaster Univeristy

Hamilton, Ontario, L8S 4K1, Canada

Location

Related Publications (1)

• Colenso-Semple LM, McKendry J, Lim C, Atherton PJ, Wilkinson DJ, Smith K, Phillips SM. Menstrual cycle phase does not influence muscle protein synthesis or whole-body myofibrillar proteolysis in response to resistance exercise. J Physiol. 2025 Mar;603(5):1109-1121. doi: 10.1113/JP287342. Epub 2024 Dec 4.

  PMID: 39630025 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: In a randomized fashion, participants will have one leg undergo unilateral resistance exercise training to assess the muscle protein synthetic response in each menstrual cycle phase OR each pill phase (active vs. placebo)

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: April 26, 2022
• Study Start: May 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: April 30, 2024
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)