The Effect of Menstrual Cycle Phase on Muscle Protein Synthesis

November 13, 2024 updated by: University of Exeter

The Effect of Menstrual Cycle Phase on Muscle Protein Synthesis Following Protein Ingestion and Resistance Exercise in Young Women

The combination of dietary protein ingestion and resistance exercise are essential to increase muscle protein synthesis. The vast majority of studies assessing protein intake following resistance exercise in young adults has been conducted exclusively in men or in studies where both men and women are assessed. The increase in muscle mass is thought to be impacted by sex hormones that fluctuate across different phases of the menstrual cycle. However, the effect of menstrual cycle phase on muscle protein synthesis following exercise is not known.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Devon
      • Exeter, Devon, United Kingdom, EX1 2LT
        • University of Exeter

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Female, aged 18-40 years
  • BMI between 18 and 30 kg/m2
  • Recreationally active
  • Regular menstrual cycle

Exclusion Criteria:

  • Smoking or use of tobacco containing products
  • Irregular menstrual cycle
  • Currently on any form of hormonal contraception
  • Post-menopausal
  • Pregnant or breastfeeding
  • Diagnosed metabolic/pulmonary/musculoskeletal illness
  • Diagnosed cardiovascular disease or hypertension
  • Use of medications that may impact protein metabolism or are anti-inflammatory
  • Gastrointestinal disorders
  • Allergy to pomegranate or amino acids
  • Injuries that would impact ability to complete study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Follicular
Follicular phase assessment of muscle protein synthesis.
Follicular or luteal phase
Experimental: Luteal
Luteal phase assessment of muscle protein synthesis
Follicular or luteal phase

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle protein synthesis
Time Frame: 7 hours
The rate of synthesis of new muscle protein
7 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sex hormone concentrations
Time Frame: 5 minutes
Serum oestrogen and progesterone
5 minutes
Plasma amino acid kinetics
Time Frame: 7 hours
The appearance of amino acids in the circulation.
7 hours
Serum insulin concentrations
Time Frame: 7 hours
Basal and postprandial concentrations of serum insulin
7 hours
Energy expenditure
Time Frame: 20 minutes
Basal metabolic rate
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Francis Stephens, University of Exeter

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2023

Primary Completion (Actual)

September 28, 2024

Study Completion (Actual)

September 28, 2024

Study Registration Dates

First Submitted

January 10, 2024

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

November 15, 2024

Last Update Submitted That Met QC Criteria

November 13, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 4539513

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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