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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06268678
Other study ID # 4539513
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 8, 2023
Est. completion date January 30, 2025

Study information

Verified date February 2024
Source University of Exeter
Contact Marianna Apicella
Phone 07947803099
Email ma997@exeter.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date January 30, 2025
Est. primary completion date January 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Phase of the menstrual cycle
Follicular or luteal phase

Locations

Country Name City State
United Kingdom University of Exeter Exeter Devon

Sponsors (2)

Lead Sponsor Collaborator
University of Exeter Pvolve

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle protein synthesis The rate of synthesis of new muscle protein 7 hours
Secondary Plasma amino acid kinetics The appearance of amino acids in the circulation. 7 hours
Secondary Serum insulin concentrations Basal and postprandial concentrations of serum insulin 7 hours
Secondary Sex hormone concentrations Serum oestrogen and progesterone 5 minutes
Secondary Energy expenditure Basal metabolic rate 20 minutes
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