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NUTRALYS® Pea Protein Oral Supplementation Effects on Muscle Mass (nutralys)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02128516
First Posted: May 1, 2014
Last Update Posted: May 1, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Roquette Freres
Information provided by (Responsible Party):
Nicolas Babault, University of Burgundy
  Purpose
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.

Condition Intervention
Healthy Other: oral powder in sachet

Study Type: Interventional
Study Design: 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

Further study details as provided by Nicolas Babault, University of Burgundy:

Primary Outcome Measures:
  • Biceps brachial thickness measured using ultrasonography [ Time Frame: 12 weeks after first ingestion ]
    biceps muscle thickness measured in millimeter using images from ultrasonography


Secondary Outcome Measures:
  • 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)


Enrollment: 150
Study Start Date: January 2012
Study Completion Date: August 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
France
Centre d'Expertise de la Performance
Dijon, France, 21078
Sponsors and Collaborators
Nicolas Babault
Roquette Freres
Investigators
Principal Investigator: Francois A Allaert, MD CEN Nutriment
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nicolas Babault, Scientific and sports coordinators, University of Burgundy
ClinicalTrials.gov Identifier: NCT02128516     History of Changes
Other Study ID Numbers: CEN1118
First Submitted: April 24, 2014
First Posted: May 1, 2014
Last Update Posted: May 1, 2014
Last Verified: April 2014