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Completed

NCT Number: NCT05347667

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

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.

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Key information

Conditions

Menstrual Cycle Muscle Protein Synthesis OCP Resistance Exercise

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Exercise Metabolism Research Laboratory, McMaster Univeristy

Hamilton, Ontario, L8S 4K1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • Irregular menstrual cycle as defined in the study protocol

Treatment and study plan

Unilateral Resistance Exercise Leg

Other

One leg will perform unilateral resistance exercise

Control Leg

Other

One leg will serve as a non-exercise control

Primary outcomes

  1. Change in Rates of Muscle Protein Synthesis

    Time frame: 6 days

    The investigators will use deuterated water and skeletal muscle biopsies to calculate the synthesis of skeletal muscle proteins.

Secondary outcomes

  1. Whole-body proteolysis

    Time frame: 6 days

    The investigators will use 3-methylhistidine in urine to calculate the rate of whole-body myofibrillar protelysis

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Natural Science and Engineering Research Council of Canada (NSERC)

Registry information

Official study title

Influence of Menstrual Cycle Phase and Oral Contraceptive Pill (OCP) Use on the Muscle Protein Synthetic Response to Exercise in Young, Healthy Women

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Apr 26, 2022
Registry last updated
Jan 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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