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

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

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.

Study Overview

• Status: Terminated
• Conditions: Muscular Fatigue
• Intervention / Treatment: Drug: L-arginine aspartate (Targifor); Drug: Placebo L-arginine aspartate (Targifor)

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil
    • Sanofi-Aventis Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; Placebo	Drug: Placebo L-arginine aspartate (Targifor); Placebo of L-arginine taken orally in a single daily dose for 8 weeks
Experimental: 1; L-arginine aspartate (Targifor)	Drug: L-arginine aspartate (Targifor); 3g of L-arginine taken orally in a single daily dose for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fatigue Resistance Factor (FRF)	Throughout the study

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum force in Newton (N) and fast or explosive force	at time 30% of the maximum isometric force
Maximum force in Newton (N) and fast or explosive force	at time 50% of the maximum isometric force
Maximum force in Newton (N) and fast or explosive force	at time 90% of the maximum isometric force

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: November 4, 2008
• First Submitted That Met QC Criteria: November 4, 2008
• First Posted (Estimate): November 5, 2008

Study Record Updates

• Last Update Posted (Estimate): March 16, 2011
• Last Update Submitted That Met QC Criteria: March 15, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Excitatory Amino Acid Agents; Excitatory Amino Acid Agonists; N-Methylaspartate
• Other Study ID Numbers: LARAS_L_02921