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Protein Tracer Drink to Study Muscle Growth Influence by Oral Contraceptives (OCEV Trial)

N/A

Recruiting

Research Sponsored by University of Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

BMI between 18.5-29.9 kg/m2 (non-obese)

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 minutes

Awards & highlights

OCEV Trial Summary

This trial aims to close the gender gap in muscle research, investigating how sex hormones and oral contraceptives influence muscle growth.

Who is the study for?

This trial is for non-obese women with a BMI of 18.5-29.9 who either use monophasic oral contraceptives for more than 3 months or have regular menstrual cycles and haven't used oral contraceptives for at least 6 months.Check my eligibility

What is being tested?

The study tests how sex hormones and oral contraceptives affect muscle protein metabolism using an ex vivo model, where human serum is applied to mouse muscle cells instead of invasive tracer studies in humans.See study design

What are the potential side effects?

Since this trial uses an ex vivo model rather than direct medication, participants are not expected to experience side effects from the intervention itself.

OCEV Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My BMI is between 18.5 and 29.9, so I am not obese.

OCEV Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Protein Synthesis (Murine Cell-Based Experiments, ex-vivo experiments)

Secondary outcome measures

Urinary Measures (Muscle Protein Breakdown)

Whole-body protein synthesis

OCEV Trial Design

4Treatment groups

Experimental Treatment

Group I: Withdrawal phaseExperimental Treatment1 Intervention

48hrs after last pill (during placebo pill phase).

Group II: Mid-Luteal PhaseExperimental Treatment1 Intervention

5-9 days after ovulation (as confirmed with ovulation test kits).

Group III: Mid-Follicular PhaseExperimental Treatment1 Intervention

7-11 days after onset of menses.

Group IV: Active pill phaseExperimental Treatment1 Intervention

10-20 days after starting new pill cycle.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of TorontoLead Sponsor

690 Previous Clinical Trials

1,019,633 Total Patients Enrolled

Jonathan Aguilera, PhD StudentStudy DirectorUniversity of Toronto

1 Previous Clinical Trials

10 Total Patients Enrolled

Cassidy Tinline-Goodfellow, PhD (C)Study DirectorUniversity of Toronto

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this investigation include senior participants above the age of seventy?

"This trial is open to participants who are between 18 and 35 years of age."

Answered by AI

Is it feasible for me to become a participant in this experiment?

"The requirements for this clinical trial are that the participant is between 18 to 35 years of age and currently taking oral contraceptives. It has a goal of recruiting 10 people in total."

Answered by AI

What is the number of participants enrolled in this research?

"Affirmative. According to the data accessible on clinicaltrials.gov, this research project is presently recruiting study participants; it was initially posted on 8/9/2023 and updated most recently 11/8/2023. The trial requires 10 individuals from a single site for full enrolment completion."

Answered by AI

Is there an influx of participants currently joining this research endeavor?

"Affirmative, clinicaltrials.gov affirms that the research is actively seeking recruits with a post-date of August 9th 2023 and an update on November 8th 2023. The trial requires 10 people to enroll from one medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Oral Contraceptive vs Menstrual Cycle Ex Vivo Model

Daniel Moore 2023. "Oral Contraceptive vs Menstrual Cycle Ex Vivo Model". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06124274.