Clinical trial NCT02128516: NUTRALYS® Pea Protein Oral Supplementation Effects on Muscle Mass
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Burgundy
Sponsor class: OTHER
Collaborators: name: Roquette Freres
First posted: 2014-05-01
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Biceps brachial thickness measured using ultrasonography
timeFrame: 12 weeks after first ingestion
Secondary outcomes:
measure: Elbow flexor strength
timeFrame: 12 weeks after first ingestion
measure: Biceps circumference
timeFrame: 12 weeks after first ingestion
measure: body weight
timeFrame: 12 weeks after first ingestion
measure: tolerance
timeFrame: 12 weeks after first ingestion
measure: muscle force
timeFrame: 12 weeks after first ingestion
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre d'Expertise de la Performance
Study officials:
affiliation: CEN Nutriment
name: Francois A Allaert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.