Protocol summary

Study aim
Evaluation of the effects of a resistance, endurance training course along with supplementation of L Citrulline Malate on NO and GH in young Wrestlers
Design
Exercise and 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 City, Saeed Sports Room, 8 Weeks, 4 days a week, Exercise based on elastomeric strength training and supplementation of L Citrulline Malate, Variation in Growth Hormone factor and Nitric Oxide factor by comparing the averages in the four groups at the beginning and end of the study.
Participants/Inclusion and exclusion criteria
1. No drug intake 2. Lack of supplements of L Citrulline Malate or Arginine containing compounds, and other sports supplements 3. No history of metabolic disease 4. Lack of smoking 5. Playing in a regular and athletic club at the provincial level 6. 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
IRCT registration information
IRCT registration number: IRCT20181124041744N1
Registration date: 2018-12-30, 1397/10/09
Registration timing: retrospective

Last update: 2018-12-30, 1397/10/09
Update count: 0
Registration date
2018-12-30, 1397/10/09
Registrant information
Name
Farshad Varjavand
Name of organization / entity
Ministry of Cooperatives, Labor, and Social Affairs
Country
Iran (Islamic Republic of)
Phone
+98 21 3627 2909
Email address
varjavand@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-06, 1397/09/15
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of an endurance, resistant exercise course with L Citrulline Malate supplementation On NO and GH in young Wrestlers
Public title
The effect of exercise and L Citrulline Malate on NO and GH
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Wrestling club members The age range was between 18 and 20 years old.
Exclusion criteria:
Lack of supplements of L Citrulline Malate or arginine containing compounds
Age
From 18 years old to 20 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Actual sample size reached: 32
Randomization (investigator's opinion)
Randomized
Randomization description
Individual The statistical sample 190 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
Exercise and 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.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee: Islamic Azad University of Varamin Pishva
Street address
Naghshe jahan
City
Pishva
Province
Tehran
Postal code
1637876791
Approval date
2018-05-22, 1397/03/01
Ethics committee reference number
IR.IAU.VARAMIN.REC.1397.012

Health conditions studied

1

Description of health condition studied
Relation between Endurance, Resistance exercise course with L Citrulline Malate Supplementation on NO and GH in young Wrestlers
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Changes in NO and Comparison 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
Changes in GH and Comparison 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
Intervention group 1: L Citrulline Malate, Blood sampling for pretest immediately before starting the activity from each participate resistance and Supplements 3 grams per day for 60 days. endurance training program for 8 weeks and blood sampling at the end of the research. L Citrulline Malate Supplements of Hungarian Scitec company, 90 Kaspeln Citrulline Malate 3000 mg pro Portion
Category
N/A

2

Description
Intervention group 2: Only practice (The protocol is similar to 1) Resistance, endurance training program for 8 weeks.
Category
N/A

3

Description
Intervention group 3: Only supplements (The protocol is similar to 1) Supplements 3 grams per day For 60 days. Blood sampling at the end of the research. L Citrulline Malate Supplements of Hungarian Scitec company, 90 Kaspeln Citrulline Malate 3000 mg pro Portion
Category
N/A

4

Description
Control group 4: No training and supplementation
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
We have no illness
Full name of responsible person
Farshad Varjavand
Street address
Naghshe Jahan
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
Ministry of Cooperatives, Labor, and Social Affairs
Full name of responsible person
Farshad Varjavand
Position
Teacher
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No 14, Shiyan Building, Eskandari Alley, Taleghani Ave
City
Varamin
Province
Tehran
Postal code
3371774031
Phone
+98 21 3627 2909
Email
varjavand@hotmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ministry of Cooperatives, Labor, and Social Affairs
Full name of responsible person
Farshad Varjavand
Position
Teacher
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No 14, Shiyan Building, Eskandari Alley, Taleghani Ave
City
Varamin
Province
Tehran
Postal code
3371774031
Phone
+98 21 3627 2909
Email
varjavand@hotmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ministry of Cooperatives, Labor, and Social Affairs
Full name of responsible person
Farshad Varjavand
Position
Teacher
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No 14, Shiyan Building, Eskandari Alley, Taleghani Ave
City
Varamin
Province
Tehran
Postal code
3371774031
Phone
+98 21 3627 2909
Email
varjavand@hotmail.com

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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