Menstrual Cycle vs. Oral Contraceptives: Effects on Muscle Protein Metabolism After Resistance Exercise

NCT ID: NCT07258576

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-20

Study Completion Date

2026-09-01

Brief Summary

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The muscles of the body are constantly breaking down old proteins and building new ones. These two processes, protein breakdown and protein synthesis, together are known as protein turnover. Protein turnover is essential for maintaining healthy muscle.

Despite its importance, females have historically been underrepresented in protein metabolism research. A long-standing assumption has been that fluctuations in female sex hormones such as estrogen and progesterone, whether across the natural menstrual cycle or in individuals using oral contraceptives (OCs), make metabolism and training responses too variable to study. Because of this, many researchers have excluded female participants for logistical reasons.

Resistance exercise, such as weightlifting, is the most effective way to increase muscle size and strength. Each resistance-training session triggers muscle protein synthesis (MPS), the process by which new muscle proteins are built. Consuming dietary protein or individual amino acids further increases the rate at which new proteins are formed. Over time, higher rates of protein synthesis support muscle growth and the maintenance of other lean tissues in the body.

The purpose of this study is to examine how menstrual cycle phases and OC use influence the synthesis of proteins in both muscle tissue and the rest of the body. Improving scientific understanding in this area will support more effective, evidence-based training and nutrition recommendations for females.

Detailed Description

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Conditions

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Female Sex Hormones Menstrual Cycle Oral Contraceptives Protein Metabolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Between-Subject Crossover Design
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Mid-Luteal Phase

5-9 days post-ovulation

Group Type OTHER

Protein Beverage

Intervention Type DIETARY_SUPPLEMENT

Participants will consume 16 half-hourly (8 hours) isoenergetic, isonitrogenous beverages containing 1.2 g/kg/d protein.

Stable Isotope Tracer [D5]phenylalanine

Intervention Type DIETARY_SUPPLEMENT

Protein beverages will be enriched with the stable isotope \[D5\]phenylalanine. The use of \[D5\]phenylalanine will allow for determination of muscle protein synthesis.

Stable Isotope Tracer [13C]phenylalanine

Intervention Type DIETARY_SUPPLEMENT

Protein beverages will be enriched with the stable isotope tracer \[13C\]phenylalanine. The use of \[13C\]phenylalanine will allow for the determination of the fate of amino acids in the body (incorporation into body protein or oxidation) which can be used to determine protein requirements.

Early Follicular Phase

Days 2-6 post-menses onset

Group Type OTHER

Protein Beverage

Intervention Type DIETARY_SUPPLEMENT

Participants will consume 16 half-hourly (8 hours) isoenergetic, isonitrogenous beverages containing 1.2 g/kg/d protein.

Stable Isotope Tracer [D5]phenylalanine

Intervention Type DIETARY_SUPPLEMENT

Protein beverages will be enriched with the stable isotope \[D5\]phenylalanine. The use of \[D5\]phenylalanine will allow for determination of muscle protein synthesis.

Stable Isotope Tracer [13C]phenylalanine

Intervention Type DIETARY_SUPPLEMENT

Protein beverages will be enriched with the stable isotope tracer \[13C\]phenylalanine. The use of \[13C\]phenylalanine will allow for the determination of the fate of amino acids in the body (incorporation into body protein or oxidation) which can be used to determine protein requirements.

Active Pill Phase

Days 10-20 of active pill

Group Type OTHER

Protein Beverage

Intervention Type DIETARY_SUPPLEMENT

Participants will consume 16 half-hourly (8 hours) isoenergetic, isonitrogenous beverages containing 1.2 g/kg/d protein.

Stable Isotope Tracer [D5]phenylalanine

Intervention Type DIETARY_SUPPLEMENT

Protein beverages will be enriched with the stable isotope \[D5\]phenylalanine. The use of \[D5\]phenylalanine will allow for determination of muscle protein synthesis.

Stable Isotope Tracer [13C]phenylalanine

Intervention Type DIETARY_SUPPLEMENT

Protein beverages will be enriched with the stable isotope tracer \[13C\]phenylalanine. The use of \[13C\]phenylalanine will allow for the determination of the fate of amino acids in the body (incorporation into body protein or oxidation) which can be used to determine protein requirements.

Placebo Pill Phase

At least 48h after last active pill is taken

Group Type OTHER

Protein Beverage

Intervention Type DIETARY_SUPPLEMENT

Participants will consume 16 half-hourly (8 hours) isoenergetic, isonitrogenous beverages containing 1.2 g/kg/d protein.

Stable Isotope Tracer [D5]phenylalanine

Intervention Type DIETARY_SUPPLEMENT

Protein beverages will be enriched with the stable isotope \[D5\]phenylalanine. The use of \[D5\]phenylalanine will allow for determination of muscle protein synthesis.

Stable Isotope Tracer [13C]phenylalanine

Intervention Type DIETARY_SUPPLEMENT

Protein beverages will be enriched with the stable isotope tracer \[13C\]phenylalanine. The use of \[13C\]phenylalanine will allow for the determination of the fate of amino acids in the body (incorporation into body protein or oxidation) which can be used to determine protein requirements.

Interventions

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Protein Beverage

Participants will consume 16 half-hourly (8 hours) isoenergetic, isonitrogenous beverages containing 1.2 g/kg/d protein.

Intervention Type DIETARY_SUPPLEMENT

Stable Isotope Tracer [D5]phenylalanine

Protein beverages will be enriched with the stable isotope \[D5\]phenylalanine. The use of \[D5\]phenylalanine will allow for determination of muscle protein synthesis.

Intervention Type DIETARY_SUPPLEMENT

Stable Isotope Tracer [13C]phenylalanine

Protein beverages will be enriched with the stable isotope tracer \[13C\]phenylalanine. The use of \[13C\]phenylalanine will allow for the determination of the fate of amino acids in the body (incorporation into body protein or oxidation) which can be used to determine protein requirements.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Age: 18-40 years
* BMI between 18.5-29.9 kg/m2 (non-obese)
* Recreationally active (resistance train minimum twice a week)
* Using monophasic or triphasic oral contraceptives for \>1 year (for oral contraceptive users)
* Have regular menstrual cycles (21-35 days) for the past 3 months and discontinued any hormonal contraceptive use for at least 6 months (non-oral contraceptive users)
* Must meet a progesterone sufficiency test (non-oral contraceptive users)

Exclusion Criteria

* Mid-luteal progesterone levels \<16umol
* Chronic disease diagnosis (cardiovascular, thyroid, diabetes)
* Current or recent remission of cancer
* Regular use of non-steroidal anti-inflammatory drugs (NSAIDs; except low-dose aspirin), anticoagulants
* Use of prescription drugs that would impact muscle protein synthesis, e.g. Statins, Lithium, ADHD medication.
* Insertion of intrauterine device (IUD) - exception: copper
* Use of emergency contraception in the last 3 months (e.g. Plan B)
* Severe food allergies (e.g. soy, nuts)
* Smoking, use of performance enhancing drugs (growth hormones, testosterone)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Toronto

OTHER

Sponsor Role lead

Responsible Party

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Daniel Moore

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Goldring Center for High Performance Sport

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Daniel R Moore, PhD

Role: CONTACT

4169464088

Ines Kortebi, PhD Candidate

Role: CONTACT

Facility Contacts

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Ines Kortebi, PhD Candidate

Role: primary

6479392755

Other Identifiers

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MCOC - REB00048059

Identifier Type: -

Identifier Source: org_study_id

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