Protocol summary

Study aim
The purpose of this study was to compare the effect of BCAA and glutamine supplements and their synergistic effect on serum muscle injury indices and pain after a session of eccentric resistance exercise.
Design
A clinical trial with a control group, with parallel groups, randomized
Settings and conduct
Performing resistance training causes muscular injuries. This study is conducted on 40 non-athlete male students of the University of Gilan. The subjects are divided into four groups and the effects of supplemens and placebo on the indicators of muscle damage are measured.
Participants/Inclusion and exclusion criteria
ٍEntery conditions:Non-smokers and untrained males Exit condition: supplement consumption
Intervention groups
Group 1: Branched amino acids (0.1 g / Kg), 30 minutes before exercise Group 2: Glutamine (0.1 g / Kg), 30 minutes before exercise Group 3: Branched amino acids (0.1 g / Kg) and glutamine (0.1 g / Kg), 30 minutes before exercise Group 4: Placebo (maltodextrin) (0.1 g / kg), 30 minutes before exercise
Main outcome variables
Serum creatine kinase enzyme; Serum lactate dehydrogenase enzyme

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130227012628N2
Registration date: 2019-08-01, 1398/05/10
Registration timing: prospective

Last update: 2019-08-01, 1398/05/10
Update count: 0
Registration date
2019-08-01, 1398/05/10
Registrant information
Name
Mohammad Samadi
Name of organization / entity
Baqiyatallah University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8248 2407
Email address
m.samadi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-27, 1398/06/05
Expected recruitment end date
2019-09-27, 1398/07/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Separated And Simultaneous Consumption Of Branched-chain Amino Acids And Glutamine On Muscle Damage Indices After Eccentric Resistance Exercise
Public title
Effect Of Branched-chain Amino Acids And Glutamine On Muscle Damage
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Male Non-smoker Untrained
Exclusion criteria:
Illness Supplements consumption
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects will be divided into four groups A and B, C and D using simple randomization method and by random number table. Therefore, the unit of randomization will be individuals. First, a list of all participants will be provided. Then, by deleting the names from the list, individuals will be assigned to the study groups on the basis of the numbers already assigned to each person. Since the numbers of the participants (not their names) are assigned to the groups, and this will be done once, the researcher will not have the opportunity to change the status of the assignment of individuals or predict it. The study groups include (A) branched amino acids, group (B) glutamine, group (C) branched amino acids and glutamine and group (D), placebo.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyst, and outcome assessor in the study do not know who is in the intervention groups and who is in the placebo group.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committeeof Sport Sciences Research Institute
Street address
No.3, 5 th St., Mir Emad St. Motahari Ave.
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2019-04-28, 1398/02/08
Ethics committee reference number
IR.SSRI.REC.1397.465

Health conditions studied

1

Description of health condition studied
muscle damage
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Serum keratin kinase enzyme activity
Timepoint
Before, 24 hours, 48 ​​hours and 72 hours after intervention
Method of measurement
Level of enzyme activity by photometric method

2

Description
Serum lactate dehydrogenase enzyme activity
Timepoint
Before, 24 hours, 48 ​​hours and 72 hours after intervention
Method of measurement
Level of enzyme activity by photometric method

Secondary outcomes

empty

Intervention groups

1

Description
Intervention groupA: branched-chained amino acids (0.1g/Kg)
Category
Prevention

2

Description
Intervention group B: glutamine (0.1g/Kg)
Category
Prevention

3

Description
Intervention group C: branched-chain amino acids (0.1g/Kg) plus glutamine (0.1g/Kg)
Category
Prevention

4

Description
Control groupِ D: Maltodextrin (0.1g/Kg) as placebo
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Gilan university
Full name of responsible person
Foad Asjodi
Street address
5th kilometer of Qazvin Road, Persian Gulf Highway.
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 31 3369 0485
Email
m.samadi@gilan.ac.ir
Web page address
http://www.guilan.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mohammad Samadi
Street address
nosrati Alley, Sheikh bahaei St. MOlla sadra Ave.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 2407
Email
m.samadi@bmsu.ac.ir
Web page address
http://www.bmsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mohammad Samadi
Position
Assiatant Professsor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nosrati st., Sheikh Bahaei St., Molla Sadra Ave.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 2407
Email
samadi.mohammad@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mohammad Samadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Nosrati Alley, Sheikh Bahaei ST., Molla Sadra Ave.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 2407
Email
samadi.mohammad@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mohammad Samadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nosratri St., Sheik Bahaei St., Molla sadra Ave.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 2407
Email
samadi.mohammad@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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