Back to resultsEffect of Chronic Supplementation of L-arginine in the Muscular Performance
Primary Purpose
Muscular Fatigue
Status
Terminated
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
L-arginine aspartate (Targifor)
Placebo L-arginine aspartate (Targifor)
Sponsored by
About this trial
This is an interventional supportive care trial for Muscular Fatigue
Eligibility 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.
Sites / Locations
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
L-arginine aspartate (Targifor)
Placebo
Outcomes
Primary Outcome Measures
Fatigue Resistance Factor (FRF)
Secondary Outcome Measures
Maximum force in Newton (N) and fast or explosive force
Maximum force in Newton (N) and fast or explosive force
Maximum force in Newton (N) and fast or explosive force
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00785811
Brief Title
Effect of Chronic Supplementation of L-arginine in the Muscular Performance
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 Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Terminated
Why Stopped
Required by the investigator. The site could not recruit patients anymore.
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Fatigue
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
L-arginine aspartate (Targifor)
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
L-arginine aspartate (Targifor)
Intervention Description
3g of L-arginine taken orally in a single daily dose for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo L-arginine aspartate (Targifor)
Intervention Description
Placebo of L-arginine taken orally in a single daily dose for 8 weeks
Primary Outcome Measure Information:
Title
Fatigue Resistance Factor (FRF)
Time Frame
Throughout the study
Secondary Outcome Measure Information:
Title
Maximum force in Newton (N) and fast or explosive force
Time Frame
at time 30% of the maximum isometric force
Title
Maximum force in Newton (N) and fast or explosive force
Time Frame
at time 50% of the maximum isometric force
Title
Maximum force in Newton (N) and fast or explosive force
Time Frame
at time 90% of the maximum isometric force
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaderson Lima
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Sao Paulo
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Effect of Chronic Supplementation of L-arginine in the Muscular Performance
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