The Effect of Menstrual Cycle Phase on Muscle Protein Synthesis

NCT06268678 | Completed

• 1 other identifier: 4539513
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Menstrual Cycle Phase; Muscle Protein Synthesis

Outcome Measures

Primary Outcomes (1)

• Muscle protein synthesis

  The rate of synthesis of new muscle protein

  7 hours

Secondary Outcomes (4)

• Plasma amino acid kinetics

  7 hours

• Serum insulin concentrations

  7 hours

• Sex hormone concentrations

  5 minutes

• Energy expenditure

  20 minutes

Study Arms (2)

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

Phase of the menstrual cycle OTHER

Follicular or luteal phase

Follicular; Luteal

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female, aged 18-40 years
• BMI between 18 and 30 kg/m2
• Recreationally active
• Regular menstrual cycle

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Exeter: lead
• Pvolve: collaborator

Study Sites (1)

University of Exeter

Exeter, Devon, EX1 2LT, United Kingdom

Location

Study Officials

• Francis Stephens

  University of Exeter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised cross-over design.

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: February 20, 2024
• Study Start: December 8, 2023
• Primary Completion: September 28, 2024
• Study Completion: September 28, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)