The Effect of Menstrual Cycle Phase and Protein Dose on Muscle Protein Synthesis

NCT05178732 | Completed

• 1 other identifier: 21-10-20-B-03
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Muscle protein synthesis

  The rate of synthesis of new muscle protein

  7.5 hours

Secondary Outcomes (6)

• Plasma amino acid kinetics

  7.5 hours

• Serum insulin concentrations

  7.5 hours

• Blood flow

  7.5 hours

• Sex hormone concentrations

  5 minutes

• Gene expression

  7.5 hours

Study Arms (6)

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

Interventions

Dose of protein DIETARY_SUPPLEMENT

One of three protein doses provided

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 phase OTHER

Different phase of the menstrual cycle

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

Eligibility Criteria

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

You may qualify if:

• BMI between 18 and 30
• Recreationally active
• Regular menstrual cycle

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Exeter: lead
• P.volve: 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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: January 5, 2022
• Study Start: January 16, 2022
• Primary Completion: February 28, 2023
• Study Completion: March 31, 2023
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)