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Clinical Trial Summary

A randomised, double-blind, placebo controlled study to evaluate the effect of PeptiStrong supplementation in conjunction with an exercise program to enhance muscle strength and endurance in young male and female subjects.


Clinical Trial Description

This study aims to further investigate the use of PeptiStrong as a sports supplement by evaluating its efficacy for improving muscle strength in healthy males and females. PeptiStrong will be supplemented as a single oral dose of 2.4g/day into the volunteers' diet for 56 days in conjunction with a predefined whole body exercise programme to be performed 3 times per week. The primary outcome will measure the difference in muscle strength as assessed by one-repetition maximum (1RM) using leg extension from baseline to Day 56 between PeptiStrong and placebo. Secondary endpoints investigated during the trial will include changes in strength via the leg extension at Day 28 between PeptiStrong and Placebo, strength via bench press 1RM at Days 28 and 56, muscle endurance using 80% of baseline 1RM to failure via bench press and leg extension, number of repetitions on leg extension, muscle size measurements, muscle mass via DEXA scanning, arm, chest, thigh and waist circumference, safety and tolerability via adverse event reporting and vital sign recording. In addition to the measurements described above, volunteers will be asked to fill out a quality of life questionnaire for subjective endpoint analysis and also to record their food intake at predefined intervals during the trial. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05946746
Study type Interventional
Source Nuritas Ltd
Contact Niamh Mohan, PhD
Phone +35314301290
Email mohan.niamh@nuritas.com
Status Recruiting
Phase N/A
Start date August 9, 2023
Completion date May 23, 2024

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