Oral Contraceptive vs Menstrual Cycle Ex Vivo Model

NCT ID: NCT06124274

Last Updated: 2023-11-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-09
• Study Completion Date: 2024-09-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Mid-Follicular Phase

7-11 days after onset of menses.

Group Type: EXPERIMENTAL

Protein tracer drink

Intervention Type: BEHAVIORAL

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.

Mid-Luteal Phase

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

Group Type: EXPERIMENTAL

Protein tracer drink

Intervention Type: BEHAVIORAL

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.

Active pill phase

10-20 days after starting new pill cycle.

Group Type: EXPERIMENTAL

Protein tracer drink

Intervention Type: BEHAVIORAL

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.

Withdrawal phase

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

Group Type: EXPERIMENTAL

Protein tracer drink

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Toronto

OTHER

Sponsor Role: lead

Responsible Party

Daniel Moore

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ines Kortebi, PhD Student

Role: STUDY_DIRECTOR

University of Toronto

Cassidy Tinline-Goodfellow, PhD (C)

Role: STUDY_DIRECTOR

University of Toronto

Jonathan Aguilera, PhD Student

Role: STUDY_DIRECTOR

University of Toronto

Locations

Goldring Centre for High Performance Sport at the University of Toronto

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Daniel R Moore, PhD

Role: CONTACT

dr.moore@utoronto.ca

4169464088

Ines Kortebi, PhD Student

Role: CONTACT

ines.kortebi@mail.utoronto.ca

Facility Contacts

Daniel R Moore, PhD

Role: primary

dr.moore@utoronto.ca

416-946-4088

Ines Kortebi, MSc

Role: backup

ines.kortebi@mail.utoronto.ca

Other Identifiers

OCEV

Identifier Type: -

Identifier Source: org_study_id