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OpenTrials
Completed

NCT Number: NCT02128516

NUTRALYS® Pea Protein Oral Supplementation Effects on Muscle Mass

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.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centre d'Expertise de la Performance

Dijon, 21078, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

oral powder in sachet

Other

Other names: Sachet for oral use composed of proteins (pea or whey) and/or other components (fat-reduced cocoa, flavouring, aspartame, salt, silica dioxide)

Primary outcomes

  1. Biceps brachial thickness measured using ultrasonography

    Time frame: 12 weeks after first ingestion

    biceps muscle thickness measured in millimeter using images from ultrasonography

Secondary outcomes

  1. 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.

  2. 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)

  3. body weight

    Time frame: 12 weeks after first ingestion

    Body mass in kg on a scale

  4. tolerance

    Time frame: 12 weeks after first ingestion

    Tolerance measured by quantifying adverse events

  5. muscle force

    Time frame: 12 weeks after first ingestion

    maximal weight lifted during an arm curl exercise (kg)

Sponsors and collaborators

Lead sponsor

Nicolas Babault

Other

Collaborators

  • Roquette Freres

Registry information

Official study 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

Acronym: nutralys

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 1, 2014
Registry last updated
May 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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