Protocol summary

Summary
Objectives:Glutamine has antioxidant properties and is used for aminoacids ,proteins,nuclotids and other biologicals molecules syntesis. This study is designed the effect ofglutamine supplementation on adiponectine and TNF alpha concentration after exhaustive exercise Design: 30 healthy male students will be selected in both groups (15 controls and 15 experiments) at age 30-18 years. 0.3 gr glutamin in per kgr weight of body with 25 gr sweat and 250 cc water will be taken toexprement group and 25 gr sweat with 250 cc water taken to control group for two weeks. Setting and Conduct: Fasting blood samples are taken for both groups at the beginning and end of the supplementation. Exhaustive exercise session will be given to both groups at the 15th day. Fasting blood samples are taken at the end of exhaustive exercise. Blood samples will be used to test of biochemical and inflammatory factors. Participants including major eligibility criteria: Young healthy males with moderate physical activity in 18-30 years old. Exclusion criteria for participant selection, including: Individuals with diseases; smoking; alcoholism and other supplements consumption; having certain dietary; professional training; sedentary and having 25 and less than18.5 kg.m2. Interventions: glutamine and exhaustive exercise. Variables: Adiponectin, Malondialdehyde, Tumor necrosis factor-alpha, hs-CRP.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016092129895N1
Registration date: 2016-10-13, 1395/07/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-10-13, 1395/07/22
Registrant information
Name
leila mollazadeh
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3277 0924
Email address
le.mollazadeh@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Ardabil University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-07-20, 1395/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of glutamine supplementation on serum levels of Adiponectine and TNFα after exhaustive exercise in young males
Public title
The effect of glutamine supplementation on serum levels of Adiponectine and TNFα after exhaustive exercise in young males
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Young healthy males with moderate physical activity in 18-30 years old. Exclusion criteria: Individuals with any diseases; smoking; alcoholism and other supplements consumption; having certain dietary; professional training; sedentary and having BMI over 25 and less than18.5 kg.m2
Age
From 18 years old to 30 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Ardabil University of Medical Sciences
Street address
Ethic Committee of Ardabil University of Medical Sciences, Vice Chancellor for Research, Ardabil University of Medical Sciences, Ardabil University of Medical Sciences, Daneshgah Avenue, Ardabil, Iran
City
Ardabil
Postal code
5318985991
Approval date
2016-02-09, 1394/11/20
Ethics committee reference number
IR.ARUMS.REC.1394.112

Health conditions studied

1

Description of health condition studied
Young healthy males
ICD-10 code
Z02.5
ICD-10 code description
Examination for participation in sport

Primary outcomes

1

Description
Exhaustive exercise time
Timepoint
At the end of exercise
Method of measurement
With signs and symptoms of exhaustion

Secondary outcomes

1

Description
Total cholesterol
Timepoint
At the beginning of intervention, previous of exercise
Method of measurement
Spectrophotometry

2

Description
Triglyceride
Timepoint
At the beginning of intervention, previous of exercise
Method of measurement
Spectrophotometry

3

Description
HDL-cholesterol
Timepoint
At the beginning of intervention, previous of exercise
Method of measurement
Spectrophotometry

4

Description
hsCRP
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
ELISA

5

Description
Adiponectin
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
ELISA

6

Description
height
Timepoint
At the beginning of intervention
Method of measurement
Stadiometers

7

Description
Malondialdehyde
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
ELISA

8

Description
weight
Timepoint
At the beginning of intervention
Method of measurement
Digital scales

9

Description
Total antioxidant capacity
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
ELISA

10

Description
Tumor necrosis factor-alpha
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
ELISA

11

Description
LDL-cholesterol
Timepoint
At the beginning of intervention, previous of exercise
Method of measurement
Spectrophotometry

12

Description
Matrix metalloproteinase-2
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
ELISA

13

Description
Matrix metalloproteinase-9
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
ELISA

14

Description
Interlukine-6
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
ELISA

15

Description
Leptin
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
ELISA

16

Description
Oxidated LDL
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
ELISA

Intervention groups

1

Description
Given 0.3 gr Glutamine in per Kgr weight of body with 25 gr sweat and 250 cc water for 14 days and once exhaustive exercise for intervention group
Category
Other

2

Description
Given 25 gr sweat and 250 cc water for 14 days and once exhaustive exercise for control group
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Vice Chancellor for Research Ardabil University of Medical Sciences
Full name of responsible person
Dr Abbas Naghizade-baghi
Street address
Vice Chancellor for Research Ardabil University of Medical Sciences, Ardabil University of Medical Sciences, Daneshgah Avenue, Ardabil, Iran.
City
Ardabil

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
shahram habibzadeh
Street address
Faculty of Medicine, Ardabil University of Medical Sciences, Daneshgah Avenue, Ardabil, Iran.
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil University of Medical Sciences
Proportion provided by this source
100
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
Ardabil University of Medical Sciences
Full name of responsible person
Leila Mollazadeh
Position
Student of MSc
Other areas of specialty/work
Street address
Biochemistry Dept, Ardabil University of Medical Sciences, Ardabil University of Medical Sciences, Daneshgah Avenue, Ardabil, Iran.
City
Ardabil
Postal code
5155653466
Phone
+98 45 1383 1568
Fax
+98 15513776
Email
le.mollazadeh@arums.ac.ir
Web page address
http//:www.arums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Ali Nemati
Position
phD in nutrition
Other areas of specialty/work
Street address
Nutritional Biochemistry Dept., Faculty of Medicine, Ardabil University of Medical Sciences, Daneshg
City
Ardabil
Postal code
5618953141
Phone
+98 45 1551 2788
Fax
+98 15513776
Email
ali.nemati@arums.ac.ir
Web page address
http//:www.arums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ardabil university of Medical Sciences
Full name of responsible person
Dr Abbas Naghizadeh-Baghi
Position
PhD in Physical Education
Other areas of specialty/work
Street address
Medical School, Ardabil University of Medical Sciences, Daneshgah Street, Ardabil
City
Ardabil
Postal code
5618953141
Phone
+98 45 1223 0673
Fax
+98 12230673
Email
a.naghizade@arums.ac.ir
Web page address
htpp//www.arums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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