Effect of Chronic Supplementation of L-arginine in the Muscular Performance

Muscular Fatigue Clinical Trial

Official title:

Randomized, Double Blind, Placebo Controlled Study of Parallel Groups to Evaluate the Effect of Chronic Supplementation of L-arginine in the Muscular Performance.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00785811
• Other study ID #: LARAS_L_02921
• Status: Terminated
• Phase: Phase 4
• First received: November 4, 2008
• Last updated: March 15, 2011
• Start date: October 2008
• Est. completion date: December 2008

Study information

• Verified date: March 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to evaluate the effect of oral administration of L-arginine in the muscular fatigue of the quadriceps, expressed in terms of the Fatigue Resistance Factor (FRF). The secondary purpose of this study is to evaluate the effect of oral administration of L-arginine in the muscular force the quadriceps.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

Inclusion criteria:

Healthy young adults for both sex; Age between 20 and 55 years; Slight or moderate physical activity, 30 minutes per day, at least 3 times a week;

Exclusion criteria:

Cardiac or pulmonary disease; Previous history of knee surgery or skeletal muscular dysfunctions in hip, knee or ankle joints; Athletic person (intensive anaerobic activity); None practiced of physical activity regularly; Medications usage

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Muscular Fatigue

Intervention

Drug:
• L-arginine aspartate (Targifor)
3g of L-arginine taken orally in a single daily dose for 8 weeks
• Placebo L-arginine aspartate (Targifor)
Placebo of L-arginine taken orally in a single daily dose for 8 weeks

Locations

Country	Name	City	State
Brazil	Sanofi-Aventis Administrative Office	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue Resistance Factor (FRF)		Throughout the study	No
Secondary	Maximum force in Newton (N) and fast or explosive force		at time 30% of the maximum isometric force	No
Secondary	Maximum force in Newton (N) and fast or explosive force		at time 50% of the maximum isometric force	No
Secondary	Maximum force in Newton (N) and fast or explosive force		at time 90% of the maximum isometric force	No