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

Sponsor

Sanofi (Industry)

Overall Status

Terminated

CT.gov ID

NCT00785811

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Muscular Fatigue	Drug: L-arginine aspartate (Targifor) Drug: Placebo L-arginine aspartate (Targifor)	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

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.

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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
Placebo Comparator: 2 Placebo	Drug: Placebo L-arginine aspartate (Targifor) Placebo of L-arginine taken orally in a single daily dose for 8 weeks

Arm

Intervention/Treatment

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

Placebo Comparator: 2

Placebo

Drug: Placebo L-arginine aspartate (Targifor)

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

Outcome Measures

Primary Outcome Measures

Fatigue Resistance Factor (FRF) [Throughout the study]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis Administrative Office	Sao Paulo		Brazil

Sponsors and Collaborators

Sanofi

Investigators

Study Director: Jaderson Lima, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00785811

Other Study ID Numbers:

LARAS_L_02921

First Posted:

Nov 5, 2008

Last Update Posted:

Mar 16, 2011

Last Verified:

Mar 1, 2011

Additional relevant MeSH terms:

Fatigue

N-Methylaspartate

Study Results

No Results Posted as of Mar 16, 2011