NUTRALYS® Pea Protein Oral Supplementation Effects on Muscle Mass

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Other: oral powder in sachet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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