1.Objectives:Both acute aerobic and anaerobic exercise have the potential to result in increased free radical production, which could result in acute oxidative stress,inflammation and muscle damage.It is necessary to fnd an appropriate approach for reducing these factors.The aim of this study is to determine the effects of resveratrol supplementation on inflammation and oxidative stress in male professional basketball players;2.Design of study:randomized double blind clinical trial in two groups of intervention and control groups;3.Setting and conduct of study:10 cc bloods of athletes after 2 hours of vigorous activity at the same and certain time will be taken and questionnaires of 3-days food records at the beginning and the end of study will be completed;4.Participants:male professional basketball players between 17-35 years old.Exclusion criteria include Change in diet or physical activity patterns for any reason,compliance rate of less than 80 and being infected with any disease;5.Sample size:24 persons;6.Interventions:one capsule of resveratrol per day that contains 40 mg resveratrol;7.Duretion of intervention:6 weeks;8.Main outcome measures variables:reviewed variables include Inflammatory factors (TNF- α & IL- 6) and oxidative stress (F2 isoprostane) will be measured and compared at the beginning and end of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204212394N8
Registration date:2012-05-22, 1391/03/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-05-22, 1391/03/02
Registrant information
Name
Shima Jazayeri
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4805
Email address
sjazayeri@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2012-07-22, 1391/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Resveratrol Supplementation on Oxidative Stress and Inflammation in Male Professional Basketball Players
Public title
Effects of Resveratrol Supplementation on Inflammation and Oxidative Stress
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:1.Lack of sensitivity to Resveratrol; 2.Age 17-35 years; 3.Failure to take of multivitamin - mineral and omega - 3 supplements two weeks before the intervention; 4.No smoking; 5.Failure to take of anti-inflammatory drugs; 6.Not affected by the renal, hepatic, thyroid and hemolytic anemia disease; 7.Not affected by the skeleto-musclar disorder ; Exclusion criteria: 1.Change in diet or physical activity patterns for any reason; 2.Compliance rate of less than 80; 3.Being infected with any disease;
Age
From 17 years old to 35 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
24
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
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd, Tehran, Iran
City
Tehran
Postal code
Approval date
2012-04-08, 1391/01/20
Ethics committee reference number
130/2578/د/90
Health conditions studied
1
Description of health condition studied
athlete
ICD-10 code
Z10.3
ICD-10 code description
Routine general health check-up of sports teams
Primary outcomes
1
Description
Tumor necrosis factor-α
Timepoint
Before intervention and 6 month after intervention
Method of measurement
ELISA; pg/ml
2
Description
Interleukin -6
Timepoint
Before intervention and 6 month after intervention
Method of measurement
ELISA; pg/ml
3
Description
F2 isoprostane
Timepoint
Before intervention and 6 month after intervention
Method of measurement
ELISA; pg/ml
Secondary outcomes
empty
Intervention groups
1
Description
for intervention group: resveratrol supplement,200 mg capsul,one capsul per day for 6 months
Category
Prevention
2
Description
placebo contains Starch flour,one capsul per day for 6 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sport Club of Tehran Azad University
Full name of responsible person
Hoda Sadat Zahedi
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Sport Club of Pooya
Full name of responsible person
Hoda Sadat Zahedi
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd, Tehran, Iran.
City
Tehran
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, Tehran University of Medical Sciences
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
School of Public Health, Tehran University of Medical Sciences
Full name of responsible person
Hoda Sadat Zahedi
Position
student of mater degree of nutrition
Other areas of specialty/work
Street address
Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences, #60 Alvand Street, Argantin Square
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
hoda.s.zahedi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Public Health, Tehran University of Medical Sciences
Full name of responsible person
Shima Jazayeri
Position
Doctorate in nutrition
Other areas of specialty/work
Street address
Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences, #60 Alvand Street, Argantin Square
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
sjazayeri@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Public Health, Tehran University of Medical Sciences
Full name of responsible person
Hoda Sadat Zahedi
Position
student of master degree of nutrition
Other areas of specialty/work
Street address
Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences, #60 Alvand Street, Argantin Square
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
hoda.s.zahedi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)