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

NCT00785811 | Terminated Phase 4

• 1 other identifier: LARAS_L_02921
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Muscular Fatigue

Outcome Measures

Primary Outcomes (1)

• Fatigue Resistance Factor (FRF)

  Throughout the study

Secondary Outcomes (3)

• 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

Study Arms (2)

1

EXPERIMENTAL

L-arginine aspartate (Targifor)

Drug: L-arginine aspartate (Targifor)

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo L-arginine aspartate (Targifor)

Interventions

L-arginine aspartate (Targifor) DRUG

3g of L-arginine taken orally in a single daily dose for 8 weeks

1

Placebo L-arginine aspartate (Targifor) DRUG

Placebo of L-arginine taken orally in a single daily dose for 8 weeks

2

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

São Paulo, Brazil

Location

Study Officials

• Jaderson Lima

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 4, 2008
• First Posted: November 5, 2008
• Study Start: October 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 16, 2011

Record last verified: 2011-03

Locations

BR (1)