- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06268678
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
Conditions
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.
Sponsor
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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