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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
Sponsor:
Collaborator:
Roquette Freres
Information provided by (Responsible Party):
Nicolas Babault, University of Burgundy

April 24, 2014
May 1, 2014
May 1, 2014
January 2012
April 2012   (Final data collection date for primary outcome measure)
Biceps brachial thickness measured using ultrasonography [ Time Frame: 12 weeks after first ingestion ]
biceps muscle thickness measured in millimeter using images from ultrasonography
Same as current
No Changes Posted
  • 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)
Same as current
Not Provided
Not Provided
 
NUTRALYS® Pea Protein Oral Supplementation Effects on Muscle Mass
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
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Healthy
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)
  • Active Comparator: whey protein
    whey protein
    Intervention: Other: oral powder in sachet
  • Placebo Comparator: placebo
    placebo
    Intervention: Other: oral powder in sachet
  • Experimental: pea protein
    pea protein
    Intervention: Other: oral powder in sachet
Babault N, Païzis C, Deley G, Guérin-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
Same as current
August 2012
April 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years to 35 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT02128516
CEN1118
No
Not Provided
Not Provided
Nicolas Babault, University of Burgundy
Nicolas Babault
Roquette Freres
Principal Investigator: Francois A Allaert, MD CEN Nutriment
University of Burgundy
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP