Menstrual Cycle PhaseNCT06268678
The Effect of Menstrual Cycle Phase on Muscle Protein Synthesis
A study testing Phase of the menstrual cycle in people with Menstrual Cycle Phase and Muscle Protein Synthesis, run by University of Exeter at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Cycle Phase, Muscle Protein Synthesis
- What is being tested?
- Phase of the menstrual cycle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Dec 2023to 28 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female, aged 18-40 years
- BMI between 18 and 30 kg/m2
- Recreationally active
- Regular menstrual cycle
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Menstrual Cycle Phase, Muscle Protein Synthesis
- Being tested
- Phase of the menstrual cycle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase of the menstrual cycleOther
Follicular or luteal phase
| Study group | Role | What they receive |
|---|---|---|
| Follicular | Experimental | Follicular phase assessment of muscle protein synthesis. Receives: Other: Phase of the menstrual cycle |
| Luteal | Experimental | Luteal phase assessment of muscle protein synthesis Receives: Other: Phase of the menstrual cycle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle protein synthesis
The rate of synthesis of new muscle protein
Measured: 7 hours
Secondary outcomes (4)
Plasma amino acid kinetics
The appearance of amino acids in the circulation.
Measured: 7 hours
Serum insulin concentrations
Basal and postprandial concentrations of serum insulin
Measured: 7 hours
Sex hormone concentrations
Serum oestrogen and progesterone
Measured: 5 minutes
Energy expenditure
Basal metabolic rate
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start8 Dec 2023
- Primary completion28 Sep 2024
- Study completion28 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual Cycle PhaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised cross-over design.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- Pvolve
- Responsible party
- Sponsor
- Investigators
- Francis Stephens, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268678
- Sponsor's protocol ID
- 4539513
- Status last verified
- Nov 2024
- First submitted
- 10 Jan 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Menstrual Cycle Phase on Muscle Protein Synthesis Following Protein Ingestion and Resistance Exercise in Young Women
- ClinicalTrials.gov ID
- NCT06268678
- Acronym / sponsor ID
- 4539513
- Conditions
- Menstrual Cycle Phase, Muscle Protein Synthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- Pvolve
- Study start
- 8 Dec 2023 (actual)
- Primary completion
- 28 Sep 2024 (actual)
- Study completion
- 28 Sep 2024 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised cross-over design.
| Arm | Type | Receives |
|---|---|---|
| Follicular | Experimental | Other: Phase of the menstrual cycleFollicular phase assessment of muscle protein synthesis. |
| Luteal | Experimental | Other: Phase of the menstrual cycleLuteal phase assessment of muscle protein synthesis |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female, aged 18-40 years
- BMI between 18 and 30 kg/m2
- Recreationally active
- Regular menstrual cycle
Key exclusion criteria (11 listed)
- Smoking or use of tobacco containing products
- Irregular menstrual cycle
- Currently on any form of hormonal contraception
- Post-menopausal
- Pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phase of the menstrual cycleFollicular or luteal phase | Other | Follicular, Luteal |
Primary outcome
Muscle protein synthesis
Time frame: 7 hours
The rate of synthesis of new muscle protein
4 secondary outcomes
Plasma amino acid kinetics
Time frame: 7 hours
Serum insulin concentrations
Time frame: 7 hours
Sex hormone concentrations
Time frame: 5 minutes
Energy expenditure
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis Stephens principal investigator
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phase of the menstrual cycle in people with Menstrual Cycle Phase and Muscle Protein Synthesis, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle protein synthesis (time frame: 7 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.