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Oral Contraceptive vs Menstrual Cycle Ex Vivo Model

NCT06124274 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-11-09

No results posted yet for this study

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. 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.

Conditions

  • Contraceptives, Oral
  • Sex Hormone

Interventions

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.

Sponsors & Collaborators

  • University of Toronto

    lead OTHER

Principal Investigators

  • Ines Kortebi, PhD Student · University of Toronto

  • Cassidy Tinline-Goodfellow, PhD (C) · University of Toronto

  • Jonathan Aguilera, PhD Student · University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-09
Primary Completion
2024-09-01
Completion
2024-09-01

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06124274 on ClinicalTrials.gov