Healthy
Conditions
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.
Interventions
OTHERoral powder in sachet
Sponsors
Roquette Freres
Nicolas Babault
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biceps brachial thickness measured using ultrasonography | 12 weeks after first ingestion | biceps muscle thickness measured in millimeter using images from ultrasonography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
France
Outcome results
None listed