NCT06124274

Oral Contraceptive vs Menstrual Cycle Ex Vivo Model

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University of Toronto · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-08-09
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2023-11-09
• Last updated: 2023-11-09

Locations

1 site across 1 country: Canada