The effect of long term grape seed extract supplementation on oxidative parameters, anti oxidant factors and inflammatory biomarkers in womens volleyball
This is a randomized , double-blind and placebo-controlled clinical trial of single- core and parallel to the women's volleyball 18 to 40 years old in Kashan, which have championship sentence and not the underlying disease and during and before of study not receiving supplements.After recording baseline demographic characteristics and written consents patients randomly divided into two groups receiving grape seed capsules or placebo in double-blind, 2 times a day for 6weeks .At the beginning and end of the study blood sample was taken to evaluate the effectiveness of supplementation , for determination of total antioxidant capacity , SOD , MDA , CAT, CK, AST and CRP.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014043012438N9
Registration date:2014-05-20, 1393/02/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-05-20, 1393/02/30
Registrant information
Name
Mohsen Taghizadeh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
taghizadeh_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Barij Research Center of Medicinal Herbs
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of long term grape seed extract supplementation on oxidative parameters, anti oxidant factors and inflammatory biomarkers in womens volleyball
Public title
The effect of grape seed extract on exersice induced oxidative stress
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:female gender,18-40 years old. physical health, at least 2 years history of activity in volley ball, championship sentence
exclusion criteria:smoking and alcohol. other supplements,missin more than 2 session of practice,viruses disease, anti inflammatory and anti biotics drug
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Kashan University of Medical Sciences
Street address
Kashan University Of Medical Sciences, Kashan
City
Kashan
Postal code
Approval date
2014-04-26, 1393/02/06
Ethics committee reference number
627/1/5/29/ب
Health conditions studied
1
Description of health condition studied
Sports Nutrition
ICD-10 code
Z00.8
ICD-10 code description
Other general examinations
Primary outcomes
1
Description
antioxidant factors
Timepoint
baseline and end of study
Method of measurement
blood test
2
Description
inflammatory biomarkers
Timepoint
baseline and end of study
Method of measurement
blood test
3
Description
MDA
Timepoint
baseline and end of study
Method of measurement
blood test
4
Description
muscle damage factors
Timepoint
baseline and end of study
Method of measurement
blood test
5
Description
AST
Timepoint
Factors for muscle damage
Method of measurement
blood test
Secondary outcomes
empty
Intervention groups
1
Description
intervention group:grape seed extract capsule. 2 times in day for 6 weeks
Category
Treatment - Drugs
2
Description
Control group:placebo capsule. 2 times in day for 6 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan women's volley ball Committee
Full name of responsible person
Miss E.Malekyian
Street address
Kashan women's volley ball Committee, Kashan
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Barij Research Center of Medicinal Herbs
Full name of responsible person
Miss L.Hejazi
Street address
Kashan Mashhad Ardehal Road, KM44
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barij Research Center of Medicinal Herbs
Proportion provided by this source
100
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
Kashan University of Medical Sciences
Full name of responsible person
Dr.M.Taghizadeh
Position
PHD
Other areas of specialty/work
Street address
Kashan University Of Medical Sciences, Kashan
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
taghizadeh_m@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University
Full name of responsible person
Miss.E.Malekyian
Position
MS
Other areas of specialty/work
Street address
Kashan University
City
Kashan
Postal code
Phone
+98 36 1444 4772
Fax
Email
malekyian.e@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Barij Research Center of Medicinal Herbs
Full name of responsible person
M.Mahlouji
Position
Clinical Expert
Other areas of specialty/work
Street address
Kashan Mashhad Ardehal Road, KM44
City
Kashan
Postal code
Phone
+98 86 4446 5112
Fax
Email
mahnaz.mahlouji@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)