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

March 15, 2011 updated by: Sanofi

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 51 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: Throughout the study
Throughout the study

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • LARAS_L_02921

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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