The effect of Ginkgo biloba supplementation on serum levels of creatine kinase,tumor necrosis factor alpha، total antioxidant capacity and Malondialdehyde in non-professional male athletes after anexhaustive aerobic execise a double blinded randomized clinical trial study.
The non-professional athletes in Tabriz University of Medical Sciences are selected through a call and entry and non-entry criteria. Venous blood samples will be taken from all participants in the study after 12 hours of fasting. The samples will be stored in a -70 freezer. After 2 weeks of intervention, blood samples will be taken from people again. 24 hours later, people will participate in the sports protocol, and immediately after finishing the sports test, the blood sample of the third stage will be taken. Then, 24 hours after the exercise protocol, the fourth stage of blood sampling will be done. The random sampling method is simple. The study is double-blind, so neither the participants nor the official who provides the capsules to them will know the type of capsule.
Participants/Inclusion and exclusion criteria
Inclusion criteria: male gender, age range of 20-30 years, history of doing physical activity for at least one year and 3 days a week, no smoking and alcohol consumption. exclusion criteria: suffering from underlying diseases such as diabetes, suffering from infectious diseases during the intervention period such as a cold, performing intense physical activity 3 days before the exercise protocol, taking any antioxidant supplements in the last 6 months
Intervention groups
Ginkgo biloba supplement
Main outcome variables
Serum levels of creatine kinase(CK), tumor necrosis factor alpha(TNF-α) , total antioxidant capacity(TAC) and malondialdehyde(MDA)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190224042821N4
Registration date:2024-05-02, 1403/02/13
Registration timing:prospective
Last update:2024-05-02, 1403/02/13
Update count:0
Registration date
2024-05-02, 1403/02/13
Registrant information
Name
Ali Barzegar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 7580
Email address
barzegarali@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-04, 1403/02/15
Expected recruitment end date
2024-09-05, 1403/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Ginkgo biloba supplementation on serum levels of creatine kinase,tumor necrosis factor alpha، total antioxidant capacity and Malondialdehyde in non-professional male athletes after anexhaustive aerobic execise a double blinded randomized clinical trial study.
Public title
Effect of ginkgo biloba supplementation on exercise induced muscle damage
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
male
doing physical activity for at least one year and 3 days a week
Age range 20-30 years
No smoking or alcohol consumption
Exclusion criteria:
underlying diseases
Infectious diseases during the intervention period
Doing high intensity physical activity 3 days before the exercise protocol
Consumption of any antioxidant supplement during the last 6 months
Age
From 20 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Athletes present at Tabriz University of Medical Sciences, who met the conditions to enter the study, were explained about the mentioned plan. People who wanted to participate in the study will be randomly divided into two intervention and control groups. Selection would be simple allocation with blocking.
Blinding (investigator's opinion)
Double blinded
Blinding description
Supplements and placebo were coded so that no scholars or participants were reported
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committees of Tabriz University of Medical Sciences
Street address
Tabriz university of medical sciences Attar Neyshaburi ave Golgasht ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166/1573113
Approval date
2024-03-04, 1402/12/14
Ethics committee reference number
IR.TBZMED.REC.1402.942
Health conditions studied
1
Description of health condition studied
Exercise induced muscle damage
ICD-10 code
Z50.1
ICD-10 code description
Other physical therapy
Primary outcomes
1
Description
Creatine kinase
Timepoint
Baseline, 2 weeks after the intervention, immediately after the exercise protocol and 24 hours after the exercise protocol
Method of measurement
ELISA
2
Description
TNF-α
Timepoint
Baseline, 2 weeks after the intervention, immediately after the exercise protocol and 24 hours after the exercise protocol
Method of measurement
ELISA
3
Description
Oxidant and anti antioxidant
Timepoint
Baseline, 2 weeks after the intervention, immediately after the exercise protocol and 24 hours after the exercise protocol
Method of measurement
ELISA
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: one daily capsule of ginkgo biloba supplement prepared from Tadbir Kala Jam Company (200 mg). it will be half an hour before breakfast and for 2 weeks
Category
Treatment - Other
2
Description
Control group: one daily capsule of Non-absorbable starch prepared from Tadbir Kala Jam Company (200 mg). it will be half an hour before breakfast and for 2 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Seyyed Mohammad Hosein Aletayyeb
Street address
Tabriz University of Medical Sciences Attar Neyshaburi ave Golgasht ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166/1573113
Phone
+98 930 528 5218
Email
m.aletayyeb.1997@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehrangiz Ebrahimi Mamaghani
Street address
Faculty of Nutrition and Food sciences, Attar Neyshabouri Av, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
6987512345
Phone
+98 41 3356 7973
Email
ebrahimimamaghane@tbzmed.ac.ir
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
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Barzegar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5489624763
Phone
0098 41 335789532
Email
Alibarzegar@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Barzegar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food sciences, Attar Neyshabouri Av, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5896371459
Phone
0098 41 337899583
Email
Alibarzegar@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Barzegar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food sciences, Attar Neyshabouri Av, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
7852369421
Phone
+98 41 3375 9862
Email
Alibarzegar@hotmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
information about the main implications will be shared
When the data will become available and for how long
Start the access period 12 months after printing the results
To whom data/document is available
The data will only be available to people working in scientific institutions
Under which criteria data/document could be used
the study data will be available to other researchers only for meta-analysis studies
From where data/document is obtainable
To access the required data researchers can contact Dr. Ali Barzegar Telephone: 09143116148 Email Adress: Alibarzegar@hotmail.com
What processes are involved for a request to access data/document
The applicant must provide a brief explanation of the goals and methodology of his meta-analysis study. Applicants will be investigated by the researchers and if they all agree the requested data will be sent to the applicant by emailand in Excel file format. all these steps will not last more than 15 days.