The Effect of Menstrual Cycle Phase and a Protein-polyphenol Drink on Muscle Protein Synthesis

November 8, 2023 updated by: University of Exeter

The Effect of Menstrual Cycle Phase on Muscle Protein Synthesis in Response to Exercise and a Protein-polyphenol Drink in Young Females

Amino acid (building blocks of protein) and polyphenol supplements are commonly consumed post resistance exercise in order to aid muscle recovery. Both supplements have been shown to be beneficial in isolation, however, there is little known about the effect on recovery of combining the two.

Muscle recovery is related to the ability to build new muscle protein from amino acids (muscle protein synthesis). This response is thought to be impacted in females by hormones that fluctuate across different phases of the menstrual cycle. However, the effect of menstrual cycle phase on muscle protein synthesis during recovery is not known.

Study Overview

Study Type

Interventional

Enrollment (Actual)

28

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • BMI between 18 and 30
  • Recreationally active
  • Regular menstrual cycle

Exclusion Criteria:

  • Smoking
  • Metabolic disease
  • Any motor disorder
  • Use of over-the-counter pharmaceuticals, during the study.
  • Pomegranate, milk or lidocaine allergy
  • Taken contraceptives in the past 3 months
  • Irregular menstrual cycle (less than 9 cycles per year and a length not between 21-35 days)
  • Post-menopausal women
  • Pregnancy and lactation

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: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Protein and early
Different phases of the menstrual cycle
Experimental: Protein and late
Different phases of the menstrual cycle
Experimental: Protein-polyphenol and early
a blend of protein and polyphenol
Experimental: Protein-polyphenol and late
a blend of protein and polyphenol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle protein synthesis
Time Frame: 7.5 hours
The rate of synthesis of new muscle protein
7.5 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma amino acid kinetics
Time Frame: 7.5 hours
The appearance of amino acids in the circulation.
7.5 hours
Serum insulin concentrations
Time Frame: 7.5 hours
Basal and postprandial concentrations of serum insulin
7.5 hours
Blood flow
Time Frame: 7.5 hours
Basal and postprandial blood flow using ultrasound
7.5 hours
Sex hormone concentrations
Time Frame: 5 minutes
Serum oestrogen and progesterone
5 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)

January 16, 2022

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

March 31, 2023

Study Registration Dates

First Submitted

December 7, 2021

First Submitted That Met QC Criteria

January 4, 2022

First Posted (Actual)

January 5, 2022

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 8, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 21-10-20-B-03

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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