NUTRALYS® Pea Protein Oral Supplementation Effects on Muscle Mass

NCT02128516 — Not applicable, Completed, 150 participants, Nicolas Babault

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT02128516, acronym nutralys
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple
Enrollment	150 (Actual)
Sponsor	Nicolas Babault (Other); collaborators: Roquette Freres
Conditions	Healthy
Interventions	oral powder in sachet (Other)
Dates	start 2012-01-01, primary completion 2012-04-01, completion 2012-08-01, first posted 2014-05-01, last updated 2014-05-01
Locations	1 site in France

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
whey protein	Active comparator	Other: oral powder in sachet	whey protein
placebo	Placebo comparator	Other: oral powder in sachet	placebo
pea protein	Experimental	Other: oral powder in sachet	pea protein

oral powder in sachet (Other), also known as Sachet for oral use composed of proteins (pea or whey) and/or other components (fat-reduced cocoa, flavouring, aspartame, salt, silica dioxide)

+Outcome measures

Primary outcomes

Biceps brachial thickness measured using ultrasonography [12 weeks after first ingestion]: biceps muscle thickness measured in millimeter using images from ultrasonography

Secondary outcomes

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)

+Eligibility

Sex: Male, ages: 18 Years to 35 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Centre d'Expertise de la Performance	Dijon	France

+Publications

Results publication: 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. PMID 25628520

+Investigators

Francois A Allaert, MD, Principal investigator, CEN Nutriment