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

This study has been terminated.
(Required by the investigator. The site could not recruit patients anymore.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00785811
First Posted: November 5, 2008
Last Update Posted: March 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  Purpose
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 Intervention Phase
Muscular Fatigue Drug: L-arginine aspartate (Targifor) Drug: Placebo L-arginine aspartate (Targifor) Phase 4

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Fatigue Resistance Factor (FRF) [ Time Frame: Throughout the study ]

Secondary Outcome Measures:
  • Maximum force in Newton (N) and fast or explosive force [ Time Frame: 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 ]
  • Maximum force in Newton (N) and fast or explosive force [ Time Frame: at time 90% of the maximum isometric force ]

Enrollment: 36
Study Start Date: October 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00785811


Locations
Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Jaderson Lima Sanofi
  More Information

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00785811     History of Changes
Other Study ID Numbers: LARAS_L_02921
First Submitted: November 4, 2008
First Posted: November 5, 2008
Last Update Posted: March 16, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms
N-Methylaspartate
Excitatory Amino Acid Agonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs