Effect of supplementation of L- arginine on exercise performance, body composition,Hematological indices in 35-18 year old male athletes with cardiovascular disease prevention approach
The aim of this study is investigation the effect of l-arginine supplementation on performance, lipid profile, fasting blood glucose, blood sodium and potassium, body composition and blood pressure in 18-35 years male athletes. 50 male athletes ingest l-arginine (2 g/day) or placebo (2 g/day) for 45 days after randomized in a double blind manner. Some of the main inclusion criteria in our study: males 18-35 age؛ no consumption dietary supplement in the last two months & each of participants does not follow the intervention or catching acute or chronic disease during intervention will be excluded. Venous blood samples for determination of indicators will be taken at the beginning & end of the intervention, as well as athletic performance will be measured indirectly by the Harvard Step. Athletes during the intervention do two sessions exercise per week. They fill physical activity questionnaire and food record for each one of them at the beginning and end of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013121515807N1
Registration date:2014-03-07, 1392/12/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-03-07, 1392/12/16
Registrant information
Name
Naseh Pahlavani
Name of organization / entity
Student at Isfahan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 918 781 0104
Email address
nasehpahlavanine91@yahoo.com
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Science
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2013-11-06, 1392/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of supplementation of L- arginine on exercise performance, body composition,Hematological indices in 35-18 year old male athletes with cardiovascular disease prevention approach
Public title
Effect of sports supplements L- Arginine on athletic performance
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria included: 18-35 years old males; willing to participate in study; no smoking and alcohol; history of continuous exercise at least twice a week in a years ago; no consumption dietary supplement in the last two months; lack of history of acute or chronic disease. Exclusion criteria: failure to follow of intervention; consumption of any dietary supplements in duration of study; catching acute or chronic disease during intervention.
Age
From 18 years old to 35 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization include: L - arginine and placebo is Randomly coded by someone outside the research team and the research team know the type of supplement. The statistical analysis is unaware of the type of intervention and after the end of the project and the final report will determine the type of intervention.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan Regional Bioethics Committee
Street address
Isfahan University of Medical Sciences, Hezarjarib St., Isfahan, Iran
City
Isfahan
Postal code
6677599-33
Approval date
2013-10-23, 1392/08/01
Ethics committee reference number
392435
2
Ethics committee
Name of ethics committee
Isfahan University of Medical Science
Street address
Iran, Isfahan, hezarjerib Ave, Isfahan University of Medical Science,Faculty of Nutrition and Food Science
City
Isfahan
Postal code
12345
Approval date
2013-08-20, 1392/05/29
Ethics committee reference number
392435
Health conditions studied
1
Description of health condition studied
Prevention of cardiovascular disease risk and improve exercise performance in healthy subjects
ICD-10 code
Z00.8
ICD-10 code description
Other general examinations
Primary outcomes
1
Description
Performance
Timepoint
Before& after 45 intervention
Method of measurement
Harvard Step Test
2
Description
Sodium, potassium, fasting blood glucose and lipid profile
Timepoint
Before& after 45 intervention
Method of measurement
Blood tests
3
Description
Blood Pressure
Timepoint
Before& after 45 intervention
Method of measurement
Mercurial pressure gauge
4
Description
Body composition
Timepoint
Before& after 45 intervention
Method of measurement
Body composition analyser
Secondary outcomes
empty
Intervention groups
1
Description
Intervention with l- arginine supplementation (2 g per day) in 45 days in the intervention group. L-arginine pills is 1 gram & athletes take 2 tablets daily.
Category
Treatment - Drugs
2
Description
Placebo (2 g per day) in 45 days in the control group. Malto dextrin pills is 1 gram & athletes take 2 tablets daily.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sports Clubs of Isfahan University of Medical Science
Full name of responsible person
Dr.Mohamma hasan Entezari
Street address
Iran, Isfahan Hezar jerib Ave, Isfahan University of Medical Science, faculty of nutrition and food science
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Isfahan University of Medical Sciences
Full name of responsible person
Dr.Peyman Adibi
Street address
Isfahan University of Medical Sciences, Hezarjarib St, Isfahan Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Isfahan University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Dr.Peyman Adibi
Street address
Isfahan University of Medical Sciences, Hezarjarib St, Isfahan Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Science
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
3
Sponsor
Name of organization / entity
Assistance Reaserch of Isfahan University of Medical Science
Full name of responsible person
Dr.Peyman Adibi
Street address
Isfahan University of Medical Sciences, Hezarjarib St, Isfahan Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Assistance Reaserch of Isfahan University of Medical Science
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Student
Full name of responsible person
Naseh Pahlavani
Position
Isfahan University of Medical Science
Other areas of specialty/work
Street address
Faculty of Nutrition & Food Science, Isfahan University of Medical Science, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 937 608 1205
Fax
Email
Nasehp67@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University f Medical Science
Full name of responsible person
Dr.Mohammad Hasan Entezari
Position
Specialist in nutrition and diet therapy
Other areas of specialty/work
Street address
Faculty of Nutrition and Food Science, Isfahan University of Medical Sciences, Hezarjarib St, Isfahan Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 1792 2776
Fax
Email
Entezari@hlth.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Dr.Mohammad Hasan Entezari
Position
Specialist in nutrition and diet therapy
Other areas of specialty/work
Street address
Faculty of Nutrition and Food Science, Isfahan University of Medical Sciences, Hezarjarib St, Isfahan Isfahan, Iran
City
Isfahan
Postal code
12345
Phone
+98 31 1792 2776
Fax
Email
Entezari@hlth.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)