Protocol summary

Study aim
Comparison of the effect a period of consumption Allicin and Silybum Marianum supplementation with four weeks wrestling selective training on some of the antioxidant and oxidative indicators in trained wrestlers
Design
33 wrestlers of the Qom province in the age group of youth, 33 wrestlers in Qom, who have at least five years of continuous training experience and at least one title in the province have won the title Purposeful and voluntary will be selected. Then, they were randomly divided into 3 groups: Allicin Exercise + Supplement (11 subjects), Group 2 Exercise + Supplementation of silybium maryanum (n = 11) and Exercise + Placebo Starch (n = 11). A clinical trial with a control group, with parallel groups, two Blind, randomized
Settings and conduct
33 wrestlers in Qom, who have at least five years of continuous training experience and at least one title in the province have won the title Purposeful and voluntary will be selected.. two Blind(Participant, researcher).
Participants/Inclusion and exclusion criteria
Wrestlers who have had a continuous training record of at least five years. At least one championship title has been gained at the provincial level.
Intervention groups
Intervention group: first, 24 hours after blood sampling, the subjects received 3 tablets 300 mg containing 1/1 gram of allicin for one month each day made in Isfahan Pharmaceutical Company. Pills will be put in powder form in the capsule. Intervention group: second, 24 hours after blood sampling, the subjects received 3 tablets containing 140 mg of silybium maryanum for one month each day made in Isfahan Pharmaceutical Company. Pills will be put in powder form in the capsule Control group:Third, 24 hours after blood sampling, the subjects received 3 tablets containing Starch. Pills will be put in powder form in the capsule
Main outcome variables
MDA,SOD,TAC

General information

Reason for update
Acronym
SOD,MDA,TAC
IRCT registration information
IRCT registration number: IRCT20180705040351N1
Registration date: 2018-07-17, 1397/04/26
Registration timing: prospective

Last update: 2018-07-17, 1397/04/26
Update count: 0
Registration date
2018-07-17, 1397/04/26
Registrant information
Name
Mohammad Hassani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3665 2981
Email address
e-shahmansouri@iau-arak.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2018-08-06, 1397/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect a period of consumption Allicin and Silybum Marianum supplementation with four weeks wrestling selective training on some of the antioxidant and oxidative indicators in trained wrestlers
Public title
The effect Allicin and Silybum Marianum supplementation on some of the antioxidant and oxidative indicators
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Wrestlers who have had a continuous training record of at least five years. At least one championship title has been gained at the provincial level.
Exclusion criteria:
Age
From 15 years old to 20 years old
Gender
Male
Phase
4
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 33
Randomization (investigator's opinion)
Randomized
Randomization description
First, it is purposeful and selective and then randomly
Blinding (investigator's opinion)
Double blinded
Blinding description
Prior to the commencement of the study, supplementary canisters and placebo can be marked by a person other than the researcher so that the knowledge of the researcher and the learners about the type of capsules received is not taken into consideration. The supplement and placebo will be administered under the supervision of the same person (he is a doctor). Which also monitors the subjects.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Institutional Research Ethics Committee Islamic Azad University Boroujerd-Branch
Street address
Navab Square, Imam Khomeini Complex (Imam Khomeini), Borujerd Town
City
Arak
Province
Markazi
Postal code
6915136335
Approval date
2018-06-08, 1397/03/18
Ethics committee reference number
IR.IAU.B.REC.1397.009

Health conditions studied

1

Description of health condition studied
antioxidant and oxidative indicators
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Compare differences in the values of SOD change in different groups
Timepoint
At the beginning of the study (before the intervention) and one month after taking supplements and exercise ( one hour after training, 24 hours (fasting) and 36 (fasting).
Method of measurement
Spectrophotometer made in USA, centrifuge(hermel z310- germany), The kits and chemicals required will also be supplied by Iran's Navand Salamat Company.

2

Description
Compare differences in the values of MDA change in different groups
Timepoint
At the beginning of the study (before the intervention) and one month after taking supplements and exercise ( one hour after training, 24 hours (fasting) and 36 (fasting).
Method of measurement
Spectrophotometer made in USA, Water bath made in Iran, centrifuge(hermel z310- germany), The kits and chemicals required will also be supplied by Iran's Navand Salamat Company.

3

Description
Compare differences in the values of TAC change in different groups
Timepoint
At the beginning of the study (before the intervention) and one month after taking supplements and exercise ( one hour after training, 24 hours (fasting) and 36 (fasting).
Method of measurement
Spectrophotometer made in USA, centrifuge(hermel z310- germany), The kits and chemicals required will also be supplied by Iran's Navand Salamat Company.

Secondary outcomes

1

Description
Score Muscle soreness
Timepoint
At the beginning of the study (before the intervention) and one month after taking supplements and exercise ( one hour after training, 24 hours (fasting) and 36 (fasting).
Method of measurement
Borg Pain Questionnaire

Intervention groups

1

Description
Intervention group: first, 24 hours after blood sampling, the subjects received 3 tablets 300 mg containing 1/1 gram of allicin for one month each day made in Isfahan Pharmaceutical Company. Pills will be put in powder form in the capsule.
Category
Prevention

2

Description
Intervention group: second, 24 hours after blood sampling, the subjects received 3 tablets containing 140 mg of silybium maryanum for one month each day made in Isfahan Pharmaceutical Company. Pills will be put in powder form in the capsule.
Category
Prevention

3

Description
Control group:Third, 24 hours after blood sampling, the subjects received 3 tablets containing Starch. Pills will be put in powder form in the capsule.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Qom province clubs
Full name of responsible person
Mohammad Hassani
Street address
Qom- Pardisan - Islamic Azad University of Qom
City
Qom
Province
Ghoum
Postal code
۳۷۴۹۱۱۳۱۹۱
Phone
+98 25 3665 2981
Email
msv.55.hasani@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Reza Moazami Goodarzi
Street address
Navab Square, Imam Khomeini Complex (Imam Khomeini), Borujerd Town
City
Broujerd
Province
Lorestan
Postal code
6915136335
Phone
+98 66 4251 8001
Email
msv.55.hasani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Mohammad Hassani
Position
Sessional instructor
Latest degree
Master
Other areas of specialty/work
Sport physiology
Street address
Qom- Pardisan - Islamic Azad University of Qom
City
Qom
Province
Ghoum
Postal code
۳۷۴۹۱۱۳۱۹۱
Phone
+98 25 3665 2981
Fax
Email
msv.55.hasani@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Hassani
Position
Sessional instructor
Latest degree
Master
Other areas of specialty/work
Sport physiology
Street address
Qom- Pardisan - Islamic Azad University of Qom
City
Qom
Province
Ghoum
Postal code
۳۷۴۹۱۱۳۱۹۱
Phone
+98 25 3665 2981
Fax
Email
msv.55.hasani@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Hassani
Position
Sessional instructor
Latest degree
Master
Other areas of specialty/work
Sport physiology
Street address
Qom- Pardisan - Islamic Azad University of Qom
City
Qom
Province
Ghoum
Postal code
۳۷۴۹۱۱۳۱۹۱
Phone
+98 25 3665 2981
Fax
Email
msv.55.hasani@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Undecided - It is not yet known if there will be 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
Title and more details about the data/document
By giving the resources to all people is allowed.
When the data will become available and for how long
Next 3 months
To whom data/document is available
By giving the resources to all people is allowed.
Under which criteria data/document could be used
By giving the resources to all people is allowed.
From where data/document is obtainable
Email researcher
What processes are involved for a request to access data/document
Send an email to the researcher
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