Protocol summary

Study aim
Evaluation of the effects of a resistance-endurance training course along with supplementation of l-citrulline malate on VEGF and FGF in young bodybuilders
Design
Exercise + Supplement Exercise Supplement control A clinical trial with a control group, with parallel groups, has been randomized The sample size is 10 people in each group
Settings and conduct
pishva/ varamin- Saeed Sports Room- Weekly, 4 days a week- Exercise based on elastomeric strength training and supplementation of l-citrulline-malate-Variation in vascular endothelial growth factor and fibroblastic growth factor- By comparing the averages in the four groups at the beginning and end of the study.
Participants/Inclusion and exclusion criteria
No drug intake Regular exercise 4 sessions a week Inclusion criteria: Lack of supplements of l-citrulline malate or arginine-containing compounds - And other sports supplements No history of metabolic disease Lack of smoking Playing in a regular and athletic club at the provincial level Regular exercise 4 sessions a week
Intervention groups
Exercise + Supplement: Exercise program for 8 weeks and taking L-Citrulline Malate with a dose of 3 g per day for 60 days Exercise : Exercise program for 8 weeks Supplement:taking L-Citrulline Malate with a dose of 3 g per day for 60 days control: No Exercise and Supplement
Main outcome variables
Muscular pain,The pain of bleeding,Time to practice

General information

Reason for update
Acronym
ال سیترولین مالات و FGF و VEGF
IRCT registration information
IRCT registration number: IRCT20171210037809N1
Registration date: 2018-11-21, 1397/08/30
Registration timing: retrospective

Last update: 2018-11-21, 1397/08/30
Update count: 0
Registration date
2018-11-21, 1397/08/30
Registrant information
Name
farah nameni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8843 6932
Email address
f.nameni@yahoo.co.uk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-06, 1397/08/15
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of an endurance-resistant exercise course with supplementation with Al-Citrulline-Malate On FGF and VEGF in young bodybuilders
Public title
The effect of exercise and l-citrulline malate on FGF and VEGF
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Fitness club members The age range was between 19 and 24 years old
Exclusion criteria:
Lack of supplements of l-citrulline malate or arginine-containing compounds
Age
From 19 years old to 24 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Individual The statistical sample consists of members of the sports clubs of the provincial capital،They were selected randomly ،And had the requirements set out in the descriptive questionnaire Their names were the same on the same sheets - And among them 40 papers by an unrelated person was selected by research -Of course, the names of the people were people- They had the requirements set out in the descriptive questionnaire- There were physical and health conditions and sports
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
-

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee: Islamic Azad University of Varamin Pishva
Street address
Naghshe-jahan/Pishva
City
Pishva
Province
Tehran
Postal code
1637876791
Approval date
2018-05-22, 1397/03/01
Ethics committee reference number
IR.IAU.VARAMIN.REC.1397.007

Health conditions studied

1

Description of health condition studied
DO NOT HAVE ILLNESS
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Changes in FGF and VEGFComparison of the meanings at the beginning of the supplementary period And at the end, after the supplement And sports activities are considered
Timepoint
Before the training period and after the supplement
Method of measurement
Special kit

2

Description
VEGF : Changes in VEGFComparison of the meanings at the beginning of the supplementary period And at the end, after the supplement And sports activities are considered
Timepoint
Before the training period and after the supplement
Method of measurement
Special kit

Secondary outcomes

empty

Intervention groups

1

Description
1-Intervention group: L Citrulline Malate: Blood sampling for pretest immediately before starting the activity from each participate resistance - endurance training program for 8 weeks, Supplements 3 grams per day For 60 days. And blood sampling at the end of the research.Blood sampling at the end of the study. El Citrulline Malatol Complex, Ciudad Entrepreneur, 90 Kaspeln Citrulline Malate3000 mg pro Portion
Category
N/A

2

Description
2-control group No training and supplementation
Category
N/A

3

Description
Intervention group: 3- Group just practice - The protocol is similar to 1 resistance - endurance training program for 8 weeks,
Category
N/A

4

Description
Intervention group: 4- The group only supplements - The protocol is similar to 1: Supplements 3 grams per day For 60 days.Blood sampling at the end of the study. El Citrulline Malatol Complex, Ciudad Entrepreneur, 90 Kaspeln Citrulline Malate3000 mg pro Portion
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
We have no illness
Full name of responsible person
Saiid Naiini
Street address
Naghshe-Jahan/ Pishva
City
Pishva
Province
Tehran
Postal code
33817-74895
Phone
+98 21 3672 5011
Fax
+98 21 3672 4767
Email
info@iauvaramin.ac.ir
Web page address
http://www.iauvaramin.ac.ir.

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
IAU/Varamin
Full name of responsible person
Peyman Azizi
Street address
Naghshe- Jahan/ Pishva
City
Pishva
Province
Tehran
Postal code
33817-74895
Phone
+98 21 3672 5012
Fax
+98 21 3672 4767
Email
info@iauvaramin.ac.ir
Web page address
https://www.iau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
IAU/Varamin
Proportion provided by this source
1
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Farah Nameni
Position
Asistant Prof.
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Naghshe-Jahan/ Pishva
City
pishva
Province
Tehran
Postal code
02136724767
Phone
+98 21 3672 5014
Email
f.nameni@yahoo.co.uk

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farah Nameni
Position
Assist. Prof.
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Varamin/Pishva/ IAU
City
Varamin/Pishva
Province
Tehran
Postal code
1637876791
Phone
+98 21 3672 5014
Email
dastavard96@gmail.com
Web page address
https://www.iau.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Peyman Azizi
Position
Assist. Prof
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Naghshjahan/Pishva
City
Pishva
Province
Tehran
Postal code
33817-74895
Phone
+98 21 3672 5013
Email
info@iauvaramin.ac.ir
Web page address
https://www.iau.ac.ir/fa/branch/260

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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