The effect of citrulline malate supplementation on oxidative stress
Design
Using a table of random numbers, they are divided into two groups (an intervention group and a control group). The third person is done. And the research team will not be aware of the type of supplement provided. The duration of the intervention for each group will be 7 days, during which the intervention group and the control group will be given 6 grams of citrulline malate.
Settings and conduct
Working in Isfahan and Isfahan University of Medical Sciences
Participants/Inclusion and exclusion criteria
1-Willingness to participate in the study
2. Do not use tobacco and alcohol
3. History of playing football for three years
4. Do not use antioxidant supplements, etc. in the past month
5. Age 18 to 22 years
6. No history of any acute or chronic disease
Intervention groups
The intervention group received 6 grams of citrulline malate supplementation half an hour before exercise and the control group received placebo for 7 days.
Main outcome variables
1. There is a difference between the mean serum MDA in the control group before and after supplementation.
2- There is a difference between the mean serum TAC in the control group before and after the supplementation.
3- There is a difference between the mean serum CAT in the control group before and after the supplementation.
4- There is a difference between the mean serum SOD in the control group before and after supplementation.
There is a difference between the mean serum GSH in the control group before and after the supplementation.
6- There is a difference between the mean serum UA in the control group before and after the supplementation.
7- There is a difference between the mean serum LDH in the control group before and after supplementation.
8- There is a difference between the mean serum CK in the control group before and after the supplementation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190915044772N1
Registration date:2021-02-01, 1399/11/13
Registration timing:retrospective
Last update:2021-02-01, 1399/11/13
Update count:0
Registration date
2021-02-01, 1399/11/13
Registrant information
Name
Sadegh Mirenayat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3359 8037
Email address
sadegh.mir1374@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
2019-07-23, 1398/05/01
Actual recruitment end date
2019-09-23, 1398/07/01
Trial completion date
2019-12-06, 1398/09/15
Scientific title
The Effects of Short Term Citrulline malate Supplementation on Oxidative Stress Markers and Muscle damage of Trained Soccer Players
Public title
Citrulline Malate Supplementation on Oxidative Stress Markers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
age18-23years
Professional activity history for at least 3 years
Do not take antioxidant supplements
Satisfaction to participate in the study
Exclusion criteria:
Alcohol and tobacco consumption
Having a specific injury or illness
Allergies or digestive problems
Failure to follow the study
Age
From 18 years old to 23 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
28
Actual sample size reached:
28
More than 1 sample in each individual
Actual sample size in each individual:
2
Before supplementation and after supplementation
Randomization (investigator's opinion)
Randomized
Randomization description
The study is divided into two groups (one intervention group and one control group) using a table of random numbers. Performed by a third party. And the research team will not be aware of the type of supplement provided
Blinding (investigator's opinion)
Double blinded
Blinding description
The subjects were randomly divided into two groups a and b. Supplement and placebo were divided between the two groups without any apparent difference by one of my classmates who was outside the research team and was unaware of the type of supplements. One group received a supplement and the other group received a placebo
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8413647143
Approval date
2019-01-30, 1397/11/10
Ethics committee reference number
IR.MUI.RESEARCH.REC.1397.373
Health conditions studied
1
Description of health condition studied
Footballer and oxidative stress
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
1 - Determining and comparing the mean of serum oxidative stress indices in the control and intervention groups, before and after supplementation
Timepoint
First and 7 days later
Method of measurement
Blood samples in the laboratory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Citrulline malate supplement 6 g for 7 days (Karen Company)
Category
Rehabilitation
2
Description
Control group: placebo (malto dextrin) 6 g for 7 days (Karen Company)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Zobahan Cultural and Sports Club
Full name of responsible person
Saeid Azari
Street address
Shfagh Ave
City
Isfahan
Province
Isfehan
Postal code
8413613147
Phone
+98 31 3359 8037
Email
sadegh.mir1374@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Alavi
Street address
hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8413613147
Phone
+98 31 3792 8000
Email
sadegh.mir1374@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
amir mansoor alavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
hazar jarib
City
esfahan
Province
Isfehan
Postal code
8413613147
Phone
+98 31 3359 8037
Email
am.alavi@nutr.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Alavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8413613147
Phone
+98 31 3359 8037
Email
sadegh.mir1374@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
sadegh.mirenayat
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8413613147
Phone
+98 31 3359 8037
Email
sadegh.mir1374@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Statistical data in the article
When the data will become available and for how long
After publishing the article
To whom data/document is available
Academics
Under which criteria data/document could be used
article
From where data/document is obtainable
00989133766560
What processes are involved for a request to access data/document