NCT05946746

The Effects of PeptiStrong and Exercise to Enhance Muscle Strength in Young Subjects

A Randomised, Double-blind, Placebo Controlled Study to Evaluate the Effect of PeptiStrong Supplementation in Conjunction with an Exercise Program to Enhance Muscle Strength in Young Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Nuritas Ltd · Industry
• Sex: All
• Age: 19 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Muscle Injury

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	PeptiStrong	PeptiStrong is a protein hydrolysate derived from Vicia faba. It is a free-flowing powder, pale yellow in colour. For the purposes of the trial, PeptiStrong will be encapsulated in size '00' hydroxypropyl methylcellulose capsules.
DIETARY_SUPPLEMENT	Placebo SMCC silicated micro-crystalline cellulose	Placebo - SMCC silicated microcrystalline cellulose (INCI name: MCC, cellulose gel), For the purposes of the trial, SMCC will be encapsulated in size '00' hydropropyl methylcellulose.

Timeline

• Start date: 2023-08-09
• Primary completion: 2024-01-23
• Completion: 2024-05-23
• First posted: 2023-07-14
• Last updated: 2024-11-20

Locations

1 site across 1 country: Canada