- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05178732
The Effect of Menstrual Cycle Phase and a Protein-polyphenol Drink on Muscle Protein Synthesis
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Devon
-
Exeter, Devon, United Kingdom, EX1 2LT
- University of Exeter
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Francis Stephens, University of Exeter
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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