NUTRALYS® Pea Protein Oral Supplementation Effects on Muscle Mass (nutralys)

Controlled, Randomized, Parallel, Double-blind Study of the Effect of NUTRALYS® Pea Protein Supplementation Versus Whey Protein and Placebo on the Muscle Mass and Strength of Volunteers Engaged in Training

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: oral powder in sachet

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21078
    • Centre d'Expertise de la Performance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Other: oral powder in sachet; Other Names: Sachet for oral use composed of proteins (pea or whey) and/or other components (fat-reduced cocoa, flavouring, aspartame, salt, silica dioxide)
Active Comparator: whey protein	Other: oral powder in sachet; Other Names: Sachet for oral use composed of proteins (pea or whey) and/or other components (fat-reduced cocoa, flavouring, aspartame, salt, silica dioxide)
Experimental: pea protein	Other: oral powder in sachet; Other Names: Sachet for oral use composed of proteins (pea or whey) and/or other components (fat-reduced cocoa, flavouring, aspartame, salt, silica dioxide)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biceps brachial thickness measured using ultrasonography	biceps muscle thickness measured in millimeter using images from ultrasonography	12 weeks after first ingestion

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nicolas Babault
• Collaborators: Roquette Freres
• Investigators: Principal Investigator: Francois A Allaert, MD, CEN Nutriment

Publications and helpful links

General Publications

• Babault N, Paizis C, Deley G, Guerin-Deremaux L, Saniez MH, Lefranc-Millot C, Allaert FA. Pea proteins oral supplementation promotes muscle thickness gains during resistance training: a double-blind, randomized, Placebo-controlled clinical trial vs. Whey protein. J Int Soc Sports Nutr. 2015 Jan 21;12(1):3. doi: 10.1186/s12970-014-0064-5. eCollection 2015.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: April 24, 2014
• First Submitted That Met QC Criteria: April 29, 2014
• First Posted (Estimate): May 1, 2014

Study Record Updates

• Last Update Posted (Estimate): May 1, 2014
• Last Update Submitted That Met QC Criteria: April 29, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: CEN1118