Menstrual CycleNCT05347667
Menstrual Cycle Phase and Oral Contraceptive Pill (OCP) Use on Muscle Protein Synthesis
A study testing Unilateral Resistance Exercise Leg in people with Menstrual Cycle and Resistance Exercise, run by McMaster University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Cycle, Resistance Exercise, Muscle Protein Synthesis
- What is being tested?
- Unilateral Resistance Exercise Leg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2022to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Exercise Metabolism Research Laboratory, McMaster Univeristy
Hamilton, Ontario, L8S 4K1
About this study
Official title: Influence of Menstrual Cycle Phase and Oral Contraceptive Pill (OCP) Use on the Muscle Protein Synthetic Response to Exercise in Young, Healthy Women
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
- Being tested
- Unilateral Resistance Exercise Leg, Control Leg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral Resistance Exercise LegOther
One leg will perform unilateral resistance exercise
Control LegOther
One leg will serve as a non-exercise control
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Unilateral Resistance Exercise Leg; Other: Control Leg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 days
Secondary outcomes (1)
Whole-body proteolysis
The investigators will use 3-methylhistidine in urine to calculate the rate of whole-body myofibrillar protelysis
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start1 May 2022
- Primary completion1 Mar 2023
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Menstrual CycleStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 OR each pill phase (active vs. placebo)
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Science and Engineering Research Council of Canada (NSERC)
- Responsible party
- Principal investigator, Stuart Phillips, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347667
- Sponsor's protocol ID
- 14067
- Status last verified
- Dec 2024
- First submitted
- 21 Apr 2022
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All participants will be assigned a unique subject ID, and therefore, other researchers involved with analyses will not have access to identifying participant information.
Publications
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.
PubMed 39630025
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Menstrual Cycle Phase and Oral Contraceptive Pill (OCP) Use on the Muscle Protein Synthetic Response to Exercise in Young, Healthy Women
- ClinicalTrials.gov ID
- NCT05347667
- Acronym / sponsor ID
- 14067
- Conditions
- Menstrual Cycle, Resistance Exercise, Muscle Protein Synthesis, OCP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Natural Science and Engineering Research Council of Canada (NSERC)
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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 OR each pill phase (active vs. placebo)
| Arm | Type | Receives |
|---|---|---|
| Pre-Ovulation Unilateral Resistance Exercise OR Active OCP Phase | Experimental | Other: Unilateral Resistance Exercise Leg, Other: Control LegOne 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 |
| Post-Ovulation Unilateral Resistance Exercise OR Inactive OCP Phase | Experimental | Other: Unilateral Resistance Exercise Leg, Other: Control LegOne 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 |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unilateral Resistance Exercise LegOne leg will perform unilateral resistance exercise | Other | Post-Ovulation Unilateral Resistance Exercise OR Inactive OCP Phase, Pre-Ovulation Unilateral Resistance Exercise OR Active OCP Phase |
| Control LegOne leg will serve as a non-exercise control | Other | Post-Ovulation Unilateral Resistance Exercise OR Inactive OCP Phase, Pre-Ovulation Unilateral Resistance Exercise OR Active OCP Phase |
Primary outcome
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.
1 secondary outcome
Whole-body proteolysis
Time frame: 6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- Results publication: PubMed 39630025Colenso-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.
- Individual participant dataSharing planned: No. All participants will be assigned a unique subject ID, and therefore, other researchers involved with analyses will not have access to identifying participant information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unilateral Resistance Exercise Leg in people with Menstrual Cycle and Resistance Exercise, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Rates of Muscle Protein Synthesis (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05347667, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2025; AzTrials last refreshed its copy on 7 Nov 2026.