Protocol summary

Summary
1) Introduction and background: Football players have to train or compete in several days of a week and this intensive exercise program may not give enough time for their muscle’s rehabilitation; so the chance of muscle damage can be increased. In addition, they are susceptible to physical fatigue and impaired immune function in this intensive training program. 2) Objectives: The purpose of this study was to examine the effects of carnitine and glutamine supplementation (2 g/d of L-carnitine with or without 2 g/ d of L-glutamine) on markers of muscle damage, muscle soreness, physical fatigue and some inflammatory indicators after physical exertion on football players. 3) Design: This study is a double blind, randomized, placebo-controlled, parallel clinical trial. 4) Setting and conduct: Before of supplementation protocol, each participant had to run on the treadmill for 30 minutes at 75% VO2max (maximal oxygen consumption) intensity. After this task, subjects were randomly allocated into four groups to receive supplements for 3 weeks. On day 22, at the end of supplementation period, all experimental procedures were repeated. Blood samples were obtained at preexercise and immediately after exercise. In addition, muscle soreness and physical fatigue was assessed at both occasions and 2 days after each exercise. 5) Participants including major eligibility criteria: Twenty-eight healthy male football players with more than 6-month training background were recruited in this study. 6) Intervention: L-carnitine, L- glutamine, L-carnitine + L- glutamine and placebo. 7) main outcome measures (variables): Physical fatigue, Creatine kinase, Aspartate amino transferase, Lactate Dehydrogenase, High sensitive C-reactive protein, Tumor necrosis factor – alfa, Interleukine – 6.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138809282890N1
Registration date: 2010-06-13, 1389/03/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-06-13, 1389/03/23
Registrant information
Name
Mohammad Hozouri
Name of organization / entity
Tabriz University of medical science
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
mhozoori@alumnus.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Drug Applied Research Center, Tabriz University of Medical Sciences
Expected recruitment start date
2010-04-04, 1389/01/15
Expected recruitment end date
2010-05-05, 1389/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Glutamine and Carnitine supplement on physical fatigue, inflamatin factors and indicators of exertional muscle damage in football players
Public title
Effects of glutamine and carnitine on physical fatigue and recovery after exercise
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: - Male football players with more than 6-month training background. - Normal Homogram. Exclusion criteria: - smoking. - supplement consumer. - took drugs for a chronic disease. - Weighed less than 40 kg. - had blood hemoglobin level less than 12 g/dL. - had history of acute disease or operational condition less than 3 months ago. - donating blood less than 1 month ago.
Age
From 19 years old to 23 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 28
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
Tabriz university of medical science
Street address
Tabriz medical university- Attar avenue- Daneshgah square
City
Tabriz
Postal code
Approval date
empty
Ethics committee reference number
895

Health conditions studied

1

Description of health condition studied
Physical fatigue, exertional muscle damage and some inflammatory indicators after high intensity exercise in football players
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Serum Cratine Kinase
Timepoint
Before exercise and after exercise (Before Intervention and after intervention)
Method of measurement
Unit per liter- Enzymatic method

2

Description
Serum Lactate Dehydrogenase
Timepoint
Before exercise and after exercise (Before Intervention and after intervention)
Method of measurement
Unit per liter- Enzymatic method

3

Description
Serum Aspartate Amino Transferase
Timepoint
Before exercise and after exercise (Before Intervention and after intervention)
Method of measurement
Unit per liter- Enzymatic method

4

Description
Serum Alanine Amino Transferase
Timepoint
Before exercise and after exercise (Before Intervention and after intervention)
Method of measurement
Unit per liter- Enzymatic method

5

Description
Serum Tumor necrosis alfa
Timepoint
Before exercise and after exercise (Before Intervention and after intervention)
Method of measurement
Pg / mL - ELISA

6

Description
Serum Interleukin - 6
Timepoint
Before exercise and after exercise (Before Intervention and after intervention)
Method of measurement
Pg / mL - ELISA

7

Description
Serum High sensitive C- Reactive protein
Timepoint
Before exercise and after exercise (Before Intervention and after intervention)
Method of measurement
Pg / mL - ELISA

8

Description
Muscle soreness
Timepoint
Before exercise and after exercise (Before Intervention and after intervention)
Method of measurement
Milimeter- Visual analogue scale

9

Description
Physical fatigue
Timepoint
Before exercise and after exercise (Before Intervention and after intervention)
Method of measurement
Milimeter- Visual analogue scale

10

Description
Serum Lactate
Timepoint
Before exercise and after exercise (Before Intervention and after intervention)
Method of measurement
mg / dL - Enzymatic method

11

Description
Serum Free fatty acid
Timepoint
Before exercise and after exercise (Before Intervention and after intervention)
Method of measurement
mmol / L - ELISA

12

Description
Plasma ammonia
Timepoint
Before exercise and after exercise (Before Intervention and after intervention)
Method of measurement
mg / dL - Enzymatic method

Secondary outcomes

empty

Intervention groups

1

Description
Carnitine
Category
Rehabilitation

2

Description
Glutamine
Category
Rehabilitation

3

Description
Maltodextrine (placebo)
Category
Placebo

4

Description
Carnitine + Glutamine
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahin Sport Complex
Full name of responsible person
Ali Houshiar
Street address
Golestan Avenue- Helale Ahmar Sq. Janbazan Street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
sorour Alipour
Street address
Attar Avenue- Daneshgah Sq. - Azadi Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz university of medical sciences
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Drug Applied Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hossein Babaei
Street address
Attar Avenue- Daneshgah Sq. - Azadi Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Drug Applied Research Center, Tabriz University of Medical Sciences
Proportion provided by this source
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
Tabriz university of medical sciences
Full name of responsible person
Dr. Javad Mohtadinia
Position
Associate Professor
Other areas of specialty/work
Street address
Health and nutrition school- Golgasht avenue- Daneshgah Sq.- Azadi street
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
mohtadinia@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Mohammad Hozouri
Position
PhD student of nutrition
Other areas of specialty/work
Street address
Unit 2 - No. 29- 47 Avenue- Farjam street- Hengam street
City
Tehran
Postal code
Phone
+98 21 7719 6573
Fax
Email
mhozoori@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Mohammad Hozouri
Position
PhD student in nutrition
Other areas of specialty/work
Street address
Unit 2- No. 29- 47 Avenue- Farjam street- Hengam street
City
Tehran
Postal code
Phone
+98 21 7719 6573
Fax
Email
mhozoori@gmail.com
Web page address

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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