NUTRALYS® Pea Protein Oral Supplementation Effects on Muscle Mass

NCT ID: NCT02128516

Last Updated: 2014-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-08-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: TRIPLE

Study Groups

whey protein

whey protein

Group Type: ACTIVE_COMPARATOR

oral powder in sachet

Intervention Type: OTHER

placebo

placebo

Group Type: PLACEBO_COMPARATOR

oral powder in sachet

Intervention Type: OTHER

pea protein

pea protein

Group Type: EXPERIMENTAL

oral powder in sachet

Intervention Type: OTHER

Interventions

oral powder in sachet

Intervention Type: OTHER

Other Intervention Names

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

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Roquette Freres

INDUSTRY

Sponsor Role: collaborator

Nicolas Babault

OTHER

Sponsor Role: lead

Responsible Party

Nicolas Babault

Scientific and sports coordinators

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Francois A Allaert, MD

Role: PRINCIPAL_INVESTIGATOR

CEN Nutriment

Locations

Centre d'Expertise de la Performance

Dijon, , France

Countries

France

References

Babault N, Paizis C, Deley G, Guerin-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.

Reference Type: DERIVED

PMID: 25628520 (View on PubMed)

Other Identifiers

CEN1118

Identifier Type: -

Identifier Source: org_study_id