The aim of this study to investigate the radioprotective effect of Grape seed extract against genotoxicity induced by 6 MV x-ray irradiation in human blood lymphocytes
Design
Nine volunteers were divided into three group, the first group received 100 mg, the second group received 200mg and the third group received 600mg doses of Grape seed extract. blood samples were collected from volunteers 15 minutes before (control) and 1, 2 and 5 hours after given Grape seed extract, then samples were divided into two group, the one group as the control group(without radiation) and the other one exposed by 2Gy of 6Mv x-ray. finally, chromosomal aberrations will be assessed by micronuclei assay.
Settings and conduct
Healthy volunteers were selected, blood samples were collected from volunteers before and after given grape seed extract, to expose by x-ray samples move to the Omid Hospital of Mashhad, after of radiation and cell cultures, the number of micronuclei that represented chromosomal aberrations will be assessed.
Participants/Inclusion and exclusion criteria
Volunteers no smoker, Age of 20-30 years and did not no history of cancer, chemotherapy, radiotherapy and nuclear medicine
Intervention groups
Nine volunteers were selected, blood samples were collected from volunteers 15 minutes before and 1, 2 and 5 hours after given Grape seed extract, then samples were exposed by 2Gy of 6Mv x-ray.
Main outcome variables
The number of micronuclei
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160204026361N2
Registration date:2018-06-21, 1397/03/31
Registration timing:prospective
Last update:2018-06-21, 1397/03/31
Update count:0
Registration date
2018-06-21, 1397/03/31
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3822 8590
Email address
r-ghasemnezhad@alumnus.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
2018-06-22, 1397/04/01
Actual recruitment end date
2018-07-23, 1397/05/01
Trial completion date
empty
Scientific title
Assesment of radioprotective effect of Grape seed extract against 6 Mev X-ray in human blood lymphocyte by micronuclei assay
Public title
Radio protective effect of Grape seed extract
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy human volunteer,no smoker
No history of pharmacotherapy
Did not suffer from any serious acute or chronic diseases
Age range from 20 to 30 years
Male Sex
Exclusion criteria:
Smoker
Under pharmacotherapy
Suffer from any serious acute or chronic diseases
Age
From 20 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
9
More than 1 sample in each individual
Number of samples in each individual:
4
15 minute before and 1, 2 and 5 hours after ingestion of Grape seed extract
Actual sample size reached:
9
More than 1 sample in each individual
Actual sample size in each individual:
4
15 minute before, and 1, 2, and 5 hours after GSE oral administration
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Science, Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9138735499
Approval date
2016-05-07, 1395/02/18
Ethics committee reference number
IR. MUMS.REC.1395.68
Health conditions studied
1
Description of health condition studied
Exposure to ionizing radiation
ICD-10 code
W88.0
ICD-10 code description
Exposure to X-rays
Primary outcomes
1
Description
The number of micronuclei
Timepoint
Blood samples were collected 15 minutes before(control group) and 1, 2 and 5 hours after given Grape seed extract.
Method of measurement
Micronucleus assay
Secondary outcomes
empty
Intervention groups
1
Description
Nine volunteers selected then blood samples were collected 15 minutes before(control group) and 1, 2 and 5 hours after given grape seed extract, then exposed by 6Mv x-ray. Finally, chromosomal aberration investigates by micronucleus assay.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Artesh 550 Hospital
Full name of responsible person
Valiallah Saba
Street address
Bahar Ave., Next to Etka Market
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 2140
Email
vsaba@aut.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research Of Aja University of Medical Sciences
Full name of responsible person
Valiallah Saba
Street address
West Fatemi Ave
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
vsaba@aut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research Of Aja University of Medical Sciences
Proportion provided by this source
90
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
Mashhad University of Medical Sciences
Full name of responsible person
Reza Ghasemnezhad
Position
MSc of Radiobiology
Latest degree
Master
Other areas of specialty/work
Radiobiology and Radio safety
Street address
No. 75, Arman Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9177354418
Phone
+98 51 3822 8590
Email
Ghasemnezhad.r@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Valiallah Saba
Position
Associate Professor of AJA University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Medical Physics
Street address
AJA University of Medical Sciences., Fatemi Ave
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
vsaba@aut.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reza Ghasemnezhad
Position
Msc of Radiobiology
Latest degree
Master
Other areas of specialty/work
Radiobiology and Radio safety
Street address
No. 75, Arman Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9177354418
Phone
+98 51 3822 8590
Email
Ghasemnezhad.r@gmail.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