NUTRALYS® Pea Protein Oral Supplementation Effects on Muscle Mass

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: oral powder in sachet

• Registration Number: NCT02128516
• Lead Sponsor: Nicolas Babault

Brief Summary

this clinical trial would try to confirm whether NUTRALYS®, a fast pea protein with an intermediate profile, rich in leucines and other essential amino acids, can significantly enhance muscle mass gain during strength training. This study will compare the efficacy of NUTRALYS® to a reference product. If the results of the study demonstrate a significant improvement in relation to the placebo, not inferior to that of whey, NUTRALYS® could be considered as an alternative to sports nutrition products, to which many people are intolerant.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-04
• Study Completion: 2012-08
• Status Verified: 2014-04
• Study First Submitted: 2014-04-24
• Study First Submitted QC: 2014-04-29
• Last Update Submitted: 2014-04-29
• Study First Posted: 2014-05-01
• Last Update Posted: 2014-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 150

Inclusion Criteria

• Male subjects from 18 to 35 years of age:
• engaged in moderate or occasional sports activity;
• having given their written informed consent;
• in gainful employment or a student;
• in possession of a medical certificate of fitness for sports

Exclusion Criteria

• Subject already engaged in regular sports or training increasing muscle strength or volume in the upper limbs and particularly the biceps brachial;
• Subject engaged or having engaged in the last 6 months in weight training more than once a week;
• Subject having had a muscle injury in the 3 months prior to the study;
• Asthmatic subject liable to be administered corticosteroids;
• Subject taking part in another trial;
• Subject with a known hypersensitivity to whey or pea proteins;
• Subject deprived of their freedom for administrative, medical or legal reasons or not in possession of the legal or ethical capacity to enter into a contract due to cognitive function impairment;
• Subject liable not to comply with the constraints required by the protocol;
• Subject not covered by health insurance;
• Subject having taken in the previous month or currently taking: medication, a dietary supplement, sports drink, food for particular nutritional uses or functional foods, of any kind, liable or described as liable to increase physical performance and notably to increase muscle mass;
• Subject taking anabolic protein or corticosteroid treatment;
• Subject on a high-protein diet.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
whey protein	oral powder in sachet	whey protein
placebo	oral powder in sachet	placebo
pea protein	oral powder in sachet	pea protein

Primary Outcome Measures

Name	Time	Method
Biceps brachial thickness measured using ultrasonography	12 weeks after first ingestion	biceps muscle thickness measured in millimeter using images from ultrasonography

Secondary Outcome Measures

Name	Time	Method
Elbow flexor strength	12 weeks after first ingestion	Elbow flexors muscle strength measured in Newton meter using a Biodex isokinetic dynamometer in concentric, eccentric and isometric conditions.
Biceps circumference	12 weeks after first ingestion	the circumference of the arm in three sites (proximal, middle and distal) using a tape (centimeter)
body weight	12 weeks after first ingestion	Body mass in kg on a scale
tolerance	12 weeks after first ingestion	Tolerance measured by quantifying adverse events
muscle force	12 weeks after first ingestion	maximal weight lifted during an arm curl exercise (kg)

Trial Locations

Locations (1)

Centre d'Expertise de la Performance; 🇫🇷 Dijon, France