Oral Contraceptive vs Menstrual Cycle Ex Vivo Model

NCT06124274 | Unknown

• 1 other identifier: OCEV
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraceptives, Oral; Sex Hormone

Keywords

Oral Contraceptive Use; Menstrual Cycle Phases; Protein Metabolism; Ex Vivo Model; Breath Test

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Whole-body protein synthesis

  6 hours

• Urinary Measures (Muscle Protein Breakdown)

  6 hours

Study Arms (4)

Mid-Follicular Phase

EXPERIMENTAL

7-11 days after onset of menses.

Behavioral: Protein tracer drink

Mid-Luteal Phase

EXPERIMENTAL

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

Behavioral: Protein tracer drink

Active pill phase

EXPERIMENTAL

10-20 days after starting new pill cycle.

Behavioral: Protein tracer drink

Withdrawal phase

EXPERIMENTAL

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

Behavioral: Protein tracer drink

Interventions

Protein tracer drink 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; Mid-Follicular Phase; Mid-Luteal Phase; Withdrawal phase

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Goldring Centre for High Performance Sport at the University of Toronto

Toronto, Ontario, M5S2C9, Canada

RECRUITING

Study Officials

• Ines Kortebi, PhD Student

  University of Toronto

  STUDY DIRECTOR

• Cassidy Tinline-Goodfellow, PhD (C)

  University of Toronto

  STUDY DIRECTOR

• Jonathan Aguilera, PhD Student

  University of Toronto

  STUDY DIRECTOR

Central Study Contacts

Daniel R Moore, PhD

CONTACT

4169464088; dr.moore@utoronto.ca

Ines Kortebi, PhD Student

CONTACT

ines.kortebi@mail.utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study uses a 4-way counterbalanced crossover design. A total 10 young women (Ages: 18-35 years old; 5 per OC and non-OC group) will be recruited and randomized to begin in either the mid-follicular (7-11 days after the onset of menses) or mid-luteal phase (5-9 days after ovulation) if part of non-OC group; and active pill (10-20 days within starting their new pill cycle) or withdrawal phase (at least 48hrs after their last pill) if part of the OC group. Participants of each group will take part in two metabolic trials, one in each phase of their menstrual cycle or pill cycle.

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: November 9, 2023
• Study Start: August 9, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)