Protocol summary

Study aim
The purpose of this study is to determine the effect of L-arginine with Vitamin C supplementation on Nitrogen balance, Body composition, Vo2max, Growth hormone, Testosterone and Cortisol in male body builders
Design
This is a double- blind randomized with control (placebo) clinical trial. The final sample includes 54 athletes who have been selected by convenience sampling method and are placed randomly in two groups of intervention (n=27) and control (n=27) for 6 weeks.
Settings and conduct
At The beginning and at the end of the study blood and urine samples are collected and the growth hormone, cortisol, testosterone, Vo2max, nitrogen balance and body composition are compared before and after the intervention
Participants/Inclusion and exclusion criteria
Inclusion criteria: tend to participate in the study; male gender; healthy people; age group between 18-35 years old; Exclusion criteria: Using anabolic drugs, cigarette, alcohol, any supplement during the study and before the study; cardiovascular diseases, diabetes, hypertension, acute psychiatric disorders, cold, inflammatory diseases, physical injury.
Intervention groups
The intervention group will receive daily 3 grams of L-arginine supplement 3 times a day with 500 mg vitamin C once a day for 6 weeks;The control group will receive 3 grams of L-arginine supplement 3 times a day with 500 mg of vitamin C as a placebo ( starch) for 6 weeks.Each 2 groups will have a training protocol for 6 weeks, 3 sessions per week for 1 hour , based on the Cramer and Ratans protocols.
Main outcome variables
Nitrogen balance; Body composition; Vo2max; Growth Hormone; Testosterone;Cortisol

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130616013678N28
Registration date: 2019-02-14, 1397/11/25
Registration timing: retrospective

Last update: 2019-02-14, 1397/11/25
Update count: 0
Registration date
2019-02-14, 1397/11/25
Registrant information
Name
Saeed Ghavamzadeh
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 1278 0803
Email address
ghavamzadeh_s@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-01, 1397/04/10
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of L-arginine with vitamin C supplementation on nitrogen balance , body composition, VO2max, serum growth hormone, testosterone and cortisol in male body builders
Public title
The effect of L-arginine with vitamin C supplementation on nitrogen balance , body composition, VO2max, serum growth hormone, testosterone and cortisol in male body builders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
tend to participate in the study male gender; Due to better access to male athletes rather than female athletes and tend to use supplemen healthy people age group between 18-35 years old Participants have done strength training for at least 1 year 3 times a week
Exclusion criteria:
Consumption of anabolic drugs Using cigarette and alcohol Consumption of vitamin C and L-arginine supplement before the intervention Having a certain diet Consumption of any supplement during the study People with cardiovascular diseases, pulmonary disease, diabetes, hypertension, acute psychiatric disorders, cold, inflammatory diseases, hypothyroidism Physical injury and illness during the intervention period Consumption of anti-inflammatory agents before and during the intervention Consumption of other supplements at least one month before the intervention
Age
From 18 years old to 35 years old
Gender
Male
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
Numbers 1 to 54 are written on the sheets and placed in a container and each patient is asked to pick a sheet randomly. At the end the ones with even numbers are placed in intervention group and the ones with odd numbers are placed in control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double blinded clinical trial that participants are randomly classified into two groups of intervention and control and none of them know in which group they are. Researchers are unaware which participants are receiving the real treatment.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
Orjhans street, Resalat Blvd, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2018-03-07, 1396/12/16
Ethics committee reference number
IR.UMSU.rec.1396.412

Health conditions studied

1

Description of health condition studied
l-arginine and vitamin c supplementation
ICD-10 code
ICD-10 code description

2

Description of health condition studied
athletic performance,vo2max
ICD-10 code
ICD-10 code description

3

Description of health condition studied
nitrogen balance
ICD-10 code
ICD-10 code description

4

Description of health condition studied
Growth Hormone ,testosterone and cortisol
ICD-10 code
ICD-10 code description

5

Description of health condition studied
male body builders
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Growth Hormone
Timepoint
before and 6 weeks after trials
Method of measurement
lab test

2

Description
Testostrone Hormone
Timepoint
before and 6 weeks after trials
Method of measurement
lab test

3

Description
Cortisol Hormone
Timepoint
before and 6 weeks after trials
Method of measurement
lab test

4

Description
Nitrogen Balance
Timepoint
before and 6 weeks after trials
Method of measurement
lab test(24 hours urine collection and measurement of nitrogen urinary urea ) and 24 hours recall (Determination of protein intake and calculation of nitrogen intake)

5

Description
Body composition (fat and protein percentage)
Timepoint
before and 6 weeks after trials
Method of measurement
Body composition analyzer (BIA)

6

Description
maximal oxygen consumption
Timepoint
before and 6 weeks after trials
Method of measurement
Queens step Test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The first group will receive a 3 gram L-Arginine supplement(karen pharmaceutical company) per day with 500 mg vitamin C (Jalinous pharmaceutical company) for the period of 6 weeks.
Category
Treatment - Other

2

Description
Control group: The second group will receive a 3 gram L-Arginine supplement per day with 500 mg placebo (instead of vitamin C) for the period of 6 weeks.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
sports and health counseling of Urmia University
Full name of responsible person
Sara Sohrabi Athar
Street address
upper floor of Shahid yaghoubi Hall , Urmia University , Shahid beheshti street
City
Urmia
Province
West Azarbaijan
Postal code
5756151818
Phone
+98 44 3275 2741
Email
info@urmia.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr Iraj Mohebbi
Street address
Urmia University of Medical Sciences staffs department, Orjhans Street, Resalat Blvd, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
mohebbi_iraj@yahoo.co.uk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr Saeed Ghavamzadeh
Position
PhD in Nutrition Science and associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Department, Faculty of Medicine, Urmia University of Medical Science, 11th Km of Nazloo Road, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3278 0803
Email
Ghavamzadeh_s@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr Saeed Ghavamzadeg
Position
PhD in Nutrition Science and Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Department, Faculty of Medicine , Urmia University of Medical Science, 11th Km of Nazloo Road, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3278 0803
Email
Ghavamzadeh_s@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Sara Sohrabi Athar
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Nutrition Department, Faculty of Medicine, Urmia University of Medical Science, 11th Km of Nazloo Road, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3278 0803
Email
s_sara41@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
-
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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