Menstrual Cycle Phase Based Training

Menstrual Cycle Clinical Trial

— MCPBT  

Official title:

Investigating the Effects of Menstrual Cycle Phase Based Training on Muscle Strength and Hypertrophy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05936424
• Other study ID #: 16355
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: March 30, 2025

Study information

• Verified date: June 2024
• Source: McMaster University
• Contact: Stuart Phillips
• Phone: 9058704650
• Email: phillis[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to employ state-of-the-art methods to fill current knowledge gaps on the effects of the menstrual cycle on resistance exercise training adaptations. This work will reduce the sex gap present in exercise physiology, improving women's health information by yielding a deeper understanding of the effect of female physiology on exercise adaptations and subsequent health benefits.

Employing a unilateral training design, participant's will have their legs randomized to one of four groups: non-exercise control (CON), exercise control (EX), Follicular based training (FOL), Luteal based training (LUT)

Researchers will compare these conditions to see if there are greater benefits to prioritizing resistance training around phases of the menstrual cycle,

Description:

Participants will be required to track their menstrual cycle (MC) for a total of four MC's. MC tracking will be done via self-reported menstrual onset and ovulation strips. During the first tracking cycle participants will be asked to come in at three time points for blood draws to confirm hormone concentrations and familiarize them with the strength testing protocol. Following the tracking month participant legs will then be blocked randomized based on leg skeletal muscle mass and strength into one of four groups: non-exercise control (CON), exercise control (EX), follicular based training (FOL) and luteal based training (LUT). Participants will then be asked to come in ~2x per week (4-6x/menstrual cycle phase) for resistance training under direct supervision. Participants will be trained in unilateral leg extension and unilateral leg press. For legs randomized to the FOL and LUT group, training volume will be manipulated by changing the number of sets completed. The FOL group will train high volume (~20+ sets per week) in their follicular phase and low volume (~5 sets/week) in their luteal phase, the opposite will be true for the LUT group. Muscle biopsies will be taken both prior to and after training to assess changes in fiber cross-sectional area (CSA) and capillarization. Segmental body composition will be assessed both prior and post training using bioelectrical impedance analysis (BIA), dual x-ray absorptiometry (DXA), and vastus lateralis cross-sectional area and thickness. Muscle strength will also be assessed pre and post training using the isokinetic dynamometer, unilateral one-repetition maximum (1RM) leg extension and unilateral 1RM leg press.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: March 30, 2025
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Women, between the ages of 18 - 30 years (inclusive)

• Have a body mass index (BMI) between 18-35 kg·m2 (inclusive)

• Be in general good health as assessed by a general health questionnaire

• Non-smoking

• Regular menstrual cycle (21-35 days, inclusive)

• Not using hormonal contraceptives

• Willing and able to provide informed consent

Exclusion Criteria:

• Use of tobacco or related products.

• Ineligible to participate in physical activity based on get active questionnaire (GAQ)

• Any concurrent medical, orthopedic, or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements.

• Current illnesses which could interfere with the study (e.g. prolonged severe diarrhea, regurgitation, difficulty swallowing)

• Use of hormonal contraceptives

• Currently pregnant

• Training more than 3x/week for the past 6 months.

• Have any electronic medical or metal implants

• A history of neuromuscular disorders or muscle/bone wasting diseases

• 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

• Excessive alcohol consumption (>21 units/wk)

• History of bleeding diathesis, platelet or coagulation disorders, or antiplatelet/anticoagulation therapy

Related Conditions & MeSH terms

• Menstrual Cycle
• Resistance Exercise

Intervention

Other:
• Unilateral Resistance Exercise Leg
One will perform unilateral resistance exercise
• Non-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	Muscle Hypertrophy	The investigators will be measuring participant's muscle cross-sectional area of the quadriceps pre and post training intervention via ultrasound (US); US is used to measure skeletal muscle thickness and cross-sectional area. A trained and experienced study investigator will perform the US measures. US will be used to measure the cross-sectional area of the vastus lateralis muscle on both legs. After remaining supine for 15-minute, your feet will be positioned in a custom foot-hold apparatus that prevents depression of the thigh against the bed. Mid-thigh will be identified via palpation. A marker will be used to draw a line down your leg, perpendicular to the surface of the bed, and horizontal markings will be made every 2 cm serving as a guideline for ultrasound probe placement. Ultrasound images will be taken at each horizontal marking and used to measure the muscle cross-sectional area of the quadriceps.	16 weeks
Primary	Muscular Strength	The investigators will be measuring participant's muscle strength via one-repetition maximum testing using the unilateral leg press.	16 Weeks