Oral Contraceptive vs Menstrual Cycle Ex Vivo Model
OCEV
The Effect of Menstrual Phase and Oral Contraceptives on Muscle Protein Metabolism
OCEV
The Effect of Menstrual Phase and Oral Contraceptives on Muscle Protein Metabolism
Sponsor study identifier
interventional
10
1 country
1
Study Start
August 9, 2023
Actual (reported)Primary Completion
September 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 9, 2023
Actual (reported)August 17, 2023
Actual (reported)November 9, 2023
Actual (reported)September 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
60 minutes
Whole-body protein synthesis
6 hours
Urinary Measures (Muscle Protein Breakdown)
6 hours
7-11 days after onset of menses.
5-9 days after ovulation (as confirmed with ovulation test kits).
10-20 days after starting new pill cycle.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Goldring Centre for High Performance Sport at the University of Toronto
Toronto, Ontario, M5S2C9, Canada
Ines Kortebi, PhD Student
University of Toronto
Cassidy Tinline-Goodfellow, PhD (C)
University of Toronto
Jonathan Aguilera, PhD Student
University of Toronto
First Submitted
August 17, 2023
First Posted
November 9, 2023
Study Start
A Study of Continuous Oral Contraceptives and Doxycycline
48hrs after last pill (during placebo pill phase).
Contact the study team to confirm eligibility.
August 9, 2023
Actual (reported)Primary Completion
September 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 9, 2023
Record last verified: 2023-11
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Source: ClinicalTrials.gov.
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