Menstrual Cycle Phase Muscle Protein Synthesis

Menstrual Cycle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05347667
• Other study ID #: 14067
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: October 2023
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: April 30, 2024
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Menstrual Cycle
• Muscle Protein Synthesis
• Resistance Exercise

Intervention

Other:
• Unilateral Resistance Exercise Leg
One leg will perform unilateral resistance exercise
• Control Leg
One leg will serve as a non-exercise control

Locations

Country	Name	City	State
Canada	Exercise Metabolism Research Laboratory, McMaster Univeristy	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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