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Evaluation of the effect of oral consumption of N-acetyl Cysteine in reducing the injuries caused by a single bout of exhaustive exercise in untrained young subjects

Protocol summary

Summary
The aim of the current study was to evaluate the effect of N-acetyl cysteine (NAC) supplementation on markers of oxidative stress and inflammatory response during a single bout of exhaustive exercise.Inclusion criteria were, participants aged between 21 and 25, either sex and exclusion criteria were, subjects who were consuming energetic drugs, smokers and those having any type of regular sport activity. In a randomized placebo-controlled double-blind clinical trial, thirty healthy, untrained young university students from both sex (males and females) with the age between 21 and 25 were selected and divided into 2 groups,including case (600 mg of effervescent tablets of N-acetyl Cysteine ) and the control group( placebo Neutral cellulose ) .Starting 24 hours before the supplementation ,blood samples were taken from all the subjects. The next blood samples were collected just before the exercise started, immediately after the exhaustive exercise (on flat treadmill running) and after one hour at rest. Malondialdehyde (MDA), total antioxidative capacity (TAC), CRP, BMI and Vo2 max were determined.We hypothesize that consumption of oral N-acetyl Cysteine before an exhaustive exercise reduces the parameters of oxidation stress and inflammation.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201208238129N2
Registration date: 2013-05-10, 1392/02/20
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-05-10, 1392/02/20
Registrant information
Name
Ali Movahed
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3332 4044
Email address
a.movahed@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
provided by the main researcher, with the help of deputy of research, Bushehr University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2013-05-31, 1392/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of oral consumption of N-acetyl Cysteine in reducing the injuries caused by a single bout of exhaustive exercise in untrained young subjects
Public title
Effect of N-acetyl cysteine in reducing the injuries caused by exhaustive exercise
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: participants aged between 21 and 25; either sex; having Vo2 max between 35 to 40 ml/kg/min ; and living in the same dormitory ; all having the same type of food. Exclusion criteria: subjects who were consuming energetic drugs; smokers; those having any type of regular sport activity.
Age
From 21 years old to 25 years old
Gender
Both
Phase
N/A
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
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Deputy Adviser,Bushehr University of Medical Sciences
Street address
Bushehr University of Medical Sciences,Reshehr street, Next to Salmon farsi Hospital, Bahmani,Bushehr,Iran.
City
Bushehr
Postal code
987518759577
Approval date
2013-04-23, 1392/02/03
Ethics committee reference number
B-15-92-2

Health conditions studied

1

Description of health condition studied
oxidative stress injuries
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
Total antioxidant capacity
Timepoint
Before the consumption of drug; one hour before start of the exercise;Immidiately after exercise;after one at rest hour
Method of measurement
By ELISA method and commercial kits

2

Description
C-reactive protein (CRP)
Timepoint
Before the consumption of drug; one hour before start of the exercise;Immidiately after exercise;after one at rest hour
Method of measurement
By ELISA method and commercial kits

3

Description
Malondealdehyde
Timepoint
Before the consumption of drug; one hour before start of the exercise;Immidiately after exercise;after one at rest hour
Method of measurement
By spectraphothometry

Secondary outcomes

1

Description
BMI
Timepoint
Before the trial
Method of measurement
weight in kilograms divided by the square of height in meters

2

Description
Vo2 max
Timepoint
Before and after the trial
Method of measurement
Cooper Standard Aerobic Test was used

Intervention groups

1

Description
Intervention group:effervescent tablets of N-acetyl cysteine as 4 times starting 24 hours before the trial
Category
Prevention

2

Description
placebo group: dextrose %3 as dissolved in water
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
The Persien Gulf Biomedical Research Institute
Full name of responsible person
Ali Movahed
Street address
oostan 19 Alley, Imam khomeini Street
City
Bushehr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Research,Bushehr University of Medical Sciences
Full name of responsible person
Afshin Ostowar
Street address
Bushehr University of Medical Sciences,Reshehr Street, Next to Salmon Farsi Hospital, Bahmani.
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research,Bushehr 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
Bushehr University of Medical Sciences
Full name of responsible person
Ali Movahed
Position
Ph.D in Biochemistry, Academic member
Other areas of specialty/work
Street address
Moallem Street, Bushehr University of Medical sciences
City
Bushehr
Postal code
Phone
+98 77 1252 9198
Fax
+98 987712520657
Email
amovahed58@gmail.com, amirali_1957@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bushehr University of Medical sciences
Full name of responsible person
Ali Movahed
Position
Ph.D Biochmistry, academic member
Other areas of specialty/work
Street address
Biochemistry Lab,Moallem Street, Bushehr University of Medical sciences
City
Bushehr
Postal code
Phone
+98 77 1252 9198
Fax
Email
amovahed58@gmail.com, amirali_1957@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Ali Movahed
Position
Ph.D, Academic member
Other areas of specialty/work
Street address
Biochemistry Lab,Moallem street,Bushehr University of Medical Sciences
City
Bushehr
Postal code
7518759577
Phone
+98 77 1252 9198
Fax
+98 25 20657
Email
amovahed58@gmail.com
Web page address
www.bpums.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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