NUTRALYS® Pea Protein Oral Supplementation Effects on Muscle Mass (nutralys)
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ClinicalTrials.gov Identifier: NCT02128516 |
Recruitment Status :
Completed
First Posted : May 1, 2014
Last Update Posted : May 1, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Other: oral powder in sachet | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
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 Start Date : | January 2012 |
Actual Primary Completion Date : | April 2012 |
Actual Study Completion Date : | August 2012 |
Arm | Intervention/treatment |
---|---|
Active Comparator: whey protein
whey protein
|
Other: oral powder in sachet
Other Name: 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
placebo
|
Other: oral powder in sachet
Other Name: 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
pea protein
|
Other: oral powder in sachet
Other Name: Sachet for oral use composed of proteins (pea or whey) and/or other components (fat-reduced cocoa, flavouring, aspartame, salt, silica dioxide) |
- Biceps brachial thickness measured using ultrasonography [ Time Frame: 12 weeks after first ingestion ]biceps muscle thickness measured in millimeter using images from ultrasonography
- Elbow flexor strength [ Time Frame: 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 [ Time Frame: 12 weeks after first ingestion ]the circumference of the arm in three sites (proximal, middle and distal) using a tape (centimeter)
- body weight [ Time Frame: 12 weeks after first ingestion ]Body mass in kg on a scale
- tolerance [ Time Frame: 12 weeks after first ingestion ]Tolerance measured by quantifying adverse events
- muscle force [ Time Frame: 12 weeks after first ingestion ]maximal weight lifted during an arm curl exercise (kg)

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Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128516
France | |
Centre d'Expertise de la Performance | |
Dijon, France, 21078 |
Principal Investigator: | Francois A Allaert, MD | CEN Nutriment |
Responsible Party: | Nicolas Babault, Scientific and sports coordinators, University of Burgundy |
ClinicalTrials.gov Identifier: | NCT02128516 |
Other Study ID Numbers: |
CEN1118 |
First Posted: | May 1, 2014 Key Record Dates |
Last Update Posted: | May 1, 2014 |
Last Verified: | April 2014 |