Muscle Protein SynthesisNCT05178732
The Effect of Menstrual Cycle Phase and Protein Dose on Muscle Protein Synthesis
A study testing Dose of protein and Menstrual cycle phase in people with Muscle Protein Synthesis, run by University of Exeter at 1 site in United Kingdom.
Trial summary
Adaptation to resistance exercise requires maximal rates of muscle protein synthesis, which can be achieved with post-exercise ingestion of ~20g of protein. These recommendations are based on studies in males and responses in females may vary. 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
- Muscle Protein Synthesis
- What is being tested?
- Dose of protein and Menstrual cycle phase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Jan 2022to 31 Mar 2023
- 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
- BMI between 18 and 30
- Recreationally active
- Regular menstrual cycle
Who cannot join
- 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
Show all 9Show fewer
- Irregular menstrual cycle (less than 9 cycles per year and a length not between 21-35 days)
- Post-menopausal women
- Pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Menstrual Cycle Phase and Protein Dose on Muscle Protein Synthesis in Response to Exercise in Young Females
Adaptation to resistance exercise requires maximal rates of muscle protein synthesis, which can be achieved with post-exercise ingestion of ~20g of protein. These recommendations are based on studies in males and responses in females may vary.
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 is not known.
- Conditions
- Muscle Protein Synthesis
- Being tested
- Dose of protein, Menstrual cycle phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose of proteinDietary supplement
One of three protein doses provided
Menstrual cycle phaseOther
Different phase of the menstrual cycle
| Study group | Role | What they receive |
|---|---|---|
| Protein dose 1 and early | Experimental | Not described Receives: Dietary Supplement: Dose of protein; Other: Menstrual cycle phase |
| Protein dose 1 and late | Experimental | Not described Receives: Dietary Supplement: Dose of protein; Other: Menstrual cycle phase |
| Protein dose 2 and early | Experimental | Not described Receives: Dietary Supplement: Dose of protein; Other: Menstrual cycle phase |
| Protein dose 2 and late | Experimental | Not described Receives: Dietary Supplement: Dose of protein; Other: Menstrual cycle phase |
| Protein dose 3 and early | Experimental | Not described Receives: Dietary Supplement: Dose of protein; Other: Menstrual cycle phase |
| Protein dose 3 and late | Experimental | Not described Receives: Dietary Supplement: Dose of protein; Other: Menstrual cycle phase |
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: 7.5 hours
Secondary outcomes (6)
Plasma amino acid kinetics
The appearance of amino acids in the circulation.
Measured: 7.5 hours
Serum insulin concentrations
Basal and postprandial concentrations of serum insulin
Measured: 7.5 hours
Blood flow
Basal and postprandial blood flow using ultrasound
Measured: 7.5 hours
Sex hormone concentrations
Serum oestrogen and progesterone
Measured: 5 minutes
Gene expression
Gene expression of muscle samples using RNA extraction
Measured: 7.5 hours
Blood glucose
Basal and postprandial concentrations of blood glucose
Measured: 7.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start16 Jan 2022
- Primary completion28 Feb 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Protein SynthesisStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- P.volve
- Responsible party
- Sponsor
- Investigators
- Francis Stephens, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178732
- Sponsor's protocol ID
- 21-10-20-B-03
- Status last verified
- Jul 2024
- First submitted
- 7 Dec 2021
- Last updated
- 24 Jul 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 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Menstrual Cycle Phase and Protein Dose on Muscle Protein Synthesis in Response to Exercise in Young Females
- ClinicalTrials.gov ID
- NCT05178732
- Acronym / sponsor ID
- 21-10-20-B-03
- Conditions
- Muscle Protein Synthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- P.volve
- Study start
- 16 Jan 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 5 Jan 2022 (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.
Adaptation to resistance exercise requires maximal rates of muscle protein synthesis, which can be achieved with post-exercise ingestion of ~20g of protein. These recommendations are based on studies in males and responses in females may vary.
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 is not known.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Protein dose 1 and early | Experimental | Dietary Supplement: Dose of protein, Other: Menstrual cycle phase |
| Protein dose 1 and late | Experimental | Dietary Supplement: Dose of protein, Other: Menstrual cycle phase |
| Protein dose 2 and early | Experimental | Dietary Supplement: Dose of protein, Other: Menstrual cycle phase |
| Protein dose 2 and late | Experimental | Dietary Supplement: Dose of protein, Other: Menstrual cycle phase |
| Protein dose 3 and early | Experimental | Dietary Supplement: Dose of protein, Other: Menstrual cycle phase |
| Protein dose 3 and late | Experimental | Dietary Supplement: Dose of protein, Other: Menstrual cycle phase |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI between 18 and 30
- Recreationally active
- Regular menstrual cycle
Key exclusion criteria (9 listed)
- Smoking
- Metabolic disease
- Any motor disorder
- Use of over-the-counter pharmaceuticals, during the study.
- Pomegranate, milk or lidocaine allergy
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 |
|---|---|---|
| Dose of proteinOne of three protein doses provided | Dietary supplement | Protein dose 1 and early, Protein dose 1 and late, Protein dose 2 and early, Protein dose 2 and late, Protein dose 3 and early, Protein dose 3 and late |
| Menstrual cycle phaseDifferent phase of the menstrual cycle | Other | Protein dose 1 and early, Protein dose 1 and late, Protein dose 2 and early, Protein dose 2 and late, Protein dose 3 and early, Protein dose 3 and late |
Primary outcome
Muscle protein synthesis
Time frame: 7.5 hours
The rate of synthesis of new muscle protein
6 secondary outcomes
Plasma amino acid kinetics
Time frame: 7.5 hours
Serum insulin concentrations
Time frame: 7.5 hours
Blood flow
Time frame: 7.5 hours
Sex hormone concentrations
Time frame: 5 minutes
Gene expression
Time frame: 7.5 hours
Blood glucose
Time frame: 7.5 hours
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 24 Jul 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 Dose of protein and Menstrual cycle phase in people with 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 3 inclusion and 9 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 24 Jul 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: 7.5 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 24 Jul 2024.