The Effect of Menstrual Cycle Phase on Muscle Protein Syn... | NCT06268678

Studies
The Effect of Menstrual Cycle Phase on Muscle Protein Synthesis

NCT06268678

Sponsor

University of Exeter

Status

Completed

Last Update Posted

Nov 15, 2024Actual

Enrollment

14Actual

Phase

Not Applicable

Conditions

Menstrual Cycle Phase
Muscle Protein Synthesis

Interventions

Phase of the menstrual cycle

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 8, 2023Actual

Primary Completion Date

Sep 28, 2024Actual

Completion Date

Sep 28, 2024Actual

First Submitted Date

Jan 10, 2024

First Submission Date that Met QC Criteria

Feb 12, 2024

First Posted Date

Feb 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2024

Last Update Posted Date

Nov 15, 2024Actual

Name	Class
Pvolve	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Follicular	Experimental	Follicular phase assessment of muscle protein synthesis.	Other: Phase of the menstrual cycle
Luteal	Experimental	Luteal phase assessment of muscle protein synthesis	Other: Phase of the menstrual cycle

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Phase of the menstrual cycle	Other	Follicular or luteal phase	Follicular Luteal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Muscle protein synthesis	The rate of synthesis of new muscle protein	7 hours

Secondary Outcomes

Measure	Description	Time Frame
Plasma amino acid kinetics	The appearance of amino acids in the circulation.	7 hours
Serum insulin concentrations	Basal and postprandial concentrations of serum insulin

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Francis Stephens	University of Exeter	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Exeter		Exeter	Devon	EX1 2LT	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided