Contraceptives, OralOCEVNCT06124274
Oral Contraceptive vs Menstrual Cycle Ex Vivo Model
A study testing Protein tracer drink in people with Contraceptives, Oral and Sex Hormone, run by University of Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraceptives, Oral, Sex Hormone
- What is being tested?
- Protein tracer drink
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 9 Aug 2023to 1 Sep 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Ines Kortebi, PhD Student contact
Canada1 site, 1 recruiting
- Recruiting
Goldring Centre for High Performance Sport at the University of Toronto
Toronto, Ontario, M5S2C9
Daniel R Moore, PhD, 416-946-4088, dr.moore@utoronto.ca
Ines Kortebi, MSc, ines.kortebi@mail.utoronto.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Contraceptives, Oral, Sex Hormone
- Being tested
- Protein tracer drink
- Keywords
- Oral Contraceptive Use, Menstrual Cycle Phases, Protein Metabolism, Ex Vivo Model, Breath Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein tracer drinkBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mid-Follicular Phase | Experimental | 7-11 days after onset of menses. Receives: Behavioral: Protein tracer drink |
| Mid-Luteal Phase | Experimental | 5-9 days after ovulation (as confirmed with ovulation test kits). Receives: Behavioral: Protein tracer drink |
| Active pill phase | Experimental | 10-20 days after starting new pill cycle. Receives: Behavioral: Protein tracer drink |
| Withdrawal phase | Experimental | 48hrs after last pill (during placebo pill phase). Receives: Behavioral: Protein tracer drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein Synthesis (Murine Cell-Based Experiments, ex-vivo experiments)
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
Measured: 60 minutes
Secondary outcomes (2)
Whole-body protein synthesis
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).
Measured: 6 hours
Urinary Measures (Muscle Protein Breakdown)
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.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start9 Aug 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contraceptives, OralStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study uses a 4-way counterbalanced crossover design. A total 10 young women (Ages: 18-35 years old; 5 per OC and non-OC group) will be recruited and randomized to begin in either the mid-follicular (7-11 days after the onset of menses) or mid-luteal phase (5-9 days after ovulation) if part of non-OC group; and active pill (10-20 days within starting their new pill cycle) or withdrawal phase (at least 48hrs after their last pill) if part of the OC group. Participants of each group will take part in two metabolic trials, one in each phase of their menstrual cycle or pill cycle.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Moore, University of Toronto
- Investigators
- Ines Kortebi, PhD Student, Study director, University of TorontoCassidy Tinline-Goodfellow, PhD (C), Study director, University of TorontoJonathan Aguilera, PhD Student, Study director, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124274
- Sponsor's protocol ID
- OCEV
- Acronym
- OCEV
- Status last verified
- Nov 2023
- First submitted
- 17 Aug 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Menstrual Phase and Oral Contraceptives on Muscle Protein Metabolism
- ClinicalTrials.gov ID
- NCT06124274
- Acronym / sponsor ID
- OCEV / OCEV
- Conditions
- Contraceptives, Oral, Sex Hormone
- Keywords
- Oral Contraceptive Use, Menstrual Cycle Phases, Protein Metabolism, Ex Vivo Model, Breath Test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 9 Nov 2023 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This study uses a 4-way counterbalanced crossover design. A total 10 young women (Ages: 18-35 years old; 5 per OC and non-OC group) will be recruited and randomized to begin in either the mid-follicular (7-11 days after the onset of menses) or mid-luteal phase (5-9 days after ovulation) if part of non-OC group; and active pill (10-20 days within starting their new pill cycle) or withdrawal phase (at least 48hrs after their last pill) if part of the OC group. Participants of each group will take part in two metabolic trials, one in each phase of their menstrual cycle or pill cycle.
| Arm | Type | Receives |
|---|---|---|
| Mid-Follicular Phase | Experimental | Behavioral: Protein tracer drink7-11 days after onset of menses. |
| Mid-Luteal Phase | Experimental | Behavioral: Protein tracer drink5-9 days after ovulation (as confirmed with ovulation test kits). |
| Active pill phase | Experimental | Behavioral: Protein tracer drink10-20 days after starting new pill cycle. |
| Withdrawal phase | Experimental | Behavioral: Protein tracer drink48hrs after last pill (during placebo pill phase). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Protein tracer drinkSubjects 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. | Behavioural | Active pill phase, Mid-Follicular Phase, Mid-Luteal Phase, Withdrawal phase |
Primary outcome
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
2 secondary outcomes
Whole-body protein synthesis
Time frame: 6 hours
Urinary Measures (Muscle Protein Breakdown)
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Ines Kortebi, PhD Student contact
Ines Kortebi, PhD Student study director
University of Toronto
Cassidy Tinline-Goodfellow, PhD (C) study director
University of Toronto
Jonathan Aguilera, PhD Student study director
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein tracer drink in people with Contraceptives, Oral and Sex Hormone, run by University of Toronto 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 9 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: status not confirmed, as of the sponsor's last update on 9 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel R Moore, PhD (4169464088, dr.moore@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein Synthesis (Murine Cell-Based Experiments, ex-vivo experiments) (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2023.