Menstrual Cycle Phase Muscle Protein Synthesis

Sponsor

McMaster University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05347667

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Menstrual Cycle Resistance Exercise Muscle Protein Synthesis	Other: Unilateral Resistance Exercise Leg Other: Control Leg	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in Rates of Muscle Protein Synthesis [6 days]
The investigators will use deuterated water and skeletal muscle biopsies to calculate the synthesis of skeletal muscle proteins.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Exercise Metabolism Research Laboratory, McMaster Univeristy	Hamilton	Ontario	Canada	L8S 4K1

Sponsors and Collaborators

McMaster University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stuart Phillips, Professor, McMaster University

ClinicalTrials.gov Identifier:

NCT05347667

Other Study ID Numbers:

14067

First Posted:

Apr 26, 2022

Last Update Posted:

Jul 8, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 8, 2022