Oral Contraceptive vs Menstrual Cycle Ex Vivo Model (OCEV)

November 8, 2023 updated by: Daniel Moore, University of Toronto

The Effect of Menstrual Phase and Oral Contraceptives on Muscle Protein Metabolism

Despite comprising half the population, females are often left out of muscle research due to the impact of changing hormones during the menstrual cycle and when using oral contraceptives. This makes it hard to perform costly and invasive studies involving tracers to study muscle protein metabolism. Consequently, we lack a clear understanding of how these hormonal changes affect muscle growth.

There is a need for less invasive methods to study how sex hormones and oral contraceptives influence muscle protein metabolism. Ex vivo models, where serum from participants is applied to mouse muscle cell cultures, mimic the conditions of human muscle cells and can provide initial insights.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim of the study is to develop a non-invasive model using serum from both oral contraceptive users and non-users at various stages of their cycles, to understand if different cycle or pill stages affect how muscles process proteins.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S2C9

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • BMI between 18.5-29.9 kg/m2 (I.e., non-obese).
  • For OC users: on monophasic OCs for > 3 months prior to study enrollment
  • For non-OC users: regular menstrual cycles length (25-35 days) for at least 3 months prior to study and at least 6 months off of OCs.

Exclusion Criteria:

  • Chronic disease diagnosis (cardiovascular, thyroid, diabetes)
  • Current or recent remission of cancer
  • Regular use of NSAID (except low-dose aspirin), anticoagulants
  • Use of prescription drugs that would impact metabolism, e.g. Statins, Lithium, Attention-Deficit/Hyperactivity Disorder (ADHD) medication.
  • Insertion of intrauterine device (IUD) - exception: copper
  • Use of ergogenic aids such as creatine
  • Regular Tabacco use
  • Use of illicit drugs (growth hormones, testosterone)
  • For non-OC users: Use of oral contraceptives for > 6 months prior to study enrollment - to ensure return to regular menstrual cycle.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mid-Follicular Phase
7-11 days after onset of menses.
Behavioral: Protein tracer drink
Subjects will be fed a mixed-macronutrient beverage at rest (0.75g/kg lean body mass of carbohydrates; 0.125g/kg lean body mass of protein). Amino acid composition of the protein will be modelled off the composition of egg. Leucine content will be enriched to 5% with [13 Carbon(13C)]-leucine.
Experimental: Mid-Luteal Phase
5-9 days after ovulation (as confirmed with ovulation test kits).
Behavioral: Protein tracer drink
Subjects will be fed a mixed-macronutrient beverage at rest (0.75g/kg lean body mass of carbohydrates; 0.125g/kg lean body mass of protein). Amino acid composition of the protein will be modelled off the composition of egg. Leucine content will be enriched to 5% with [13 Carbon(13C)]-leucine.
Experimental: Active pill phase
10-20 days after starting new pill cycle.
Behavioral: Protein tracer drink
Subjects will be fed a mixed-macronutrient beverage at rest (0.75g/kg lean body mass of carbohydrates; 0.125g/kg lean body mass of protein). Amino acid composition of the protein will be modelled off the composition of egg. Leucine content will be enriched to 5% with [13 Carbon(13C)]-leucine.
Experimental: Withdrawal phase
48hrs after last pill (during placebo pill phase).
Behavioral: Protein tracer drink
Subjects will be fed a mixed-macronutrient beverage at rest (0.75g/kg lean body mass of carbohydrates; 0.125g/kg lean body mass of protein). Amino acid composition of the protein will be modelled off the composition of egg. Leucine content will be enriched to 5% with [13 Carbon(13C)]-leucine.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Protein Synthesis (Murine Cell-Based Experiments, ex-vivo experiments)
Time Frame: 60 minutes
Investigators will use human serum obtained from fasted and fed timepoints (-15, 20, 40 and 60 minutes following beverage consumption) to condition cell culture media (20% volume). To determine the effects of using fasted and/or fed 'human-conditioned' culture media on cell protein synthesis, puromycin incorporation (measure of protein synthesis) will be measured via western blot and expressed relative to a no-serum control. A two-way repeated measures ANOVA will be used to analyze outcomes with cycle stage and group (OC vs non-OC) used as factors
60 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Urinary Measures (Muscle Protein Breakdown)
Time Frame: 6 hours
Investigators will measure urinary 3-methylhistidine (3MH) as an indirect marker of muscle protein breakdown over the course of the trial (6 hours) through pooled urine collection vs baseline urine.
6 hours
Whole-body protein synthesis
Time Frame: 6 hours
Investigators will measure the enrichment of [13 Carbon CO2 (13CO2)] in the breath by isotope ratio mass spectrometry (IRMS) in atom percent excess (APE). The measurement of carbon dioxide production (VCO2) and stable isotope tracer enrichment in the breath allows for the assessment of the rate at which amino acids are used for energy (i.e., oxidized), rather than for protein synthesis (i.e., retained in the body) by calculating the fraction of expired CO2 that contains 13C. Leucine retention (umol/kg) will then be calculated from the difference between the known amount of leucine provided (ingested) and leucine oxidation (as determined from 13CO2 breath enrichment).
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Toronto

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ines Kortebi, PhD Student, University of Toronto
  • Study Director: Cassidy Tinline-Goodfellow, PhD (C), University of Toronto
  • Study Director: Jonathan Aguilera, PhD Student, University of Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 9, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OCEV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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