Protocol summary

Summary
The purpose of the present study is to investigate grape seed extract supplementation and aerobic exercise effect on oxidative damages.Twenty-two untrained men were randomized in a double-blind manner to either an supplement (N = 10; 100mg/12h GSE) or placebo groups (N = 12). After 14 day supplementation period, all subjects were participated in aerobic exercise protocol with 75% VO2max on the treadmill for 30 minutes. Blood samples were obtained prior to supplementation (baseline), after fourteen day supplementation (before exercise), and immediately after the exercise protocol. In this study, Total antioxidant capacity was determined by ABTs method. Malondialdehyde was measured by spectrophotometer. Lactate, creatine kinase and lactate dehydrogenase and lipid profile counts were determined by automatic analyzers.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013081614371N1
Registration date: 2015-02-12, 1393/11/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-02-12, 1393/11/23
Registrant information
Name
Vahid Sari-Sarraf
Name of organization / entity
University of Tabriz
Country
Iran (Islamic Republic of)
Phone
+98 41 3339 3254
Email address
sarraf@tabrizu.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Tabriz
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2012-05-21, 1391/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of aerobic exercise and short-term grape seed extract supplementation on some oxidative stress indiced in men
Public title
The effect of exercise and grape seed extract supplementation
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Healthy male؛ Non-athlete؛ Non-Smoker؛Informed consent؛ without any inflammatory or oxidative supplement ingestion during 6 months prior to the study, Exclusion criteria: chronic diseases؛ injuries.
Age
From 18 years old to 22 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 22
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
Tabriz University of Medical Sciences
Street address
Golgasht St. Daneshgah St. Tabriz, Iran.
City
Tabriz
Postal code
Approval date
2012-07-30, 1391/05/09
Ethics committee reference number
9170

Health conditions studied

1

Description of health condition studied
Oxidative stress
ICD-10 code
Y57.9
ICD-10 code description
Drug or medicament, unspecified

Primary outcomes

1

Description
total antioxidant
Timepoint
14 day after the initiation of the intervention
Method of measurement
ABTs method

2

Description
Serum Malondialdehyde
Timepoint
14 day after the initiation of the intervention
Method of measurement
by thiobarbituric acid reactive substance (TBARS) and spectrophotometer

3

Description
cratine kinase
Timepoint
14 day after the initiation of the intervention
Method of measurement
by automatic analyzer and PARS azmon kit

4

Description
Blood Lactate
Timepoint
14 day after the initiation of the intervention
Method of measurement
by automatic analyzer and GIESSE kit

5

Description
LDH
Timepoint
14 day after the initiation of the intervention
Method of measurement
by automatic analyzer and PARS azmon kit

Secondary outcomes

1

Description
lipid profile
Timepoint
14 day after
Method of measurement
by automatic analyzer and PARS azmon kit

2

Description
serum hs-CRP
Timepoint
14 day after
Method of measurement
by automatic analyzer

Intervention groups

1

Description
Grape seed extract, 200 mg/day, for 14 days, after the supplementation period (14 days), all subjects participate in an aerobic exercise at 75% vo2max for 30 minutes
Category
Placebo

2

Description
Inert, 200 mg/day, for 14 days, after the supplementation period (14 days), all subjects participate in an aerobic exercise at 75% vo2max for 30 minutes.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
University of Tabriz
Full name of responsible person
Dr Vahid Sari-Sarraf
Street address
Faculty of Physical Education & Sports Sciences,University of Tabriz, 29 Bahman Ave, Tabriz, Iran.
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Tabriz
Full name of responsible person
Dr Hamidreza Ghassemzadeh
Street address
University of Tabriz, 29 Bahman Ave, Tabriz, Iran.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Tabriz
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
University of Tabriz
Full name of responsible person
Dr Vahid Sari-Sarraf
Position
PhD in Exercise Physiology
Other areas of specialty/work
Street address
Faculty of Physical Education & Sports Sciences, University of Tabriz, Tabriz, Iran.
City
Tabriz
Postal code
Phone
+98 41 3339 3254
Fax
Email
vsarisarraf@yahoo.comsarraf@tabrizu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Tabriz
Full name of responsible person
Dr Vahid Sari-Sarraf
Position
PhD in Exercise Physiology
Other areas of specialty/work
Street address
Faculty of physical education & sports sciences, University of Tabriz, Tabriz, Iran.
City
Tabriz
Postal code
Phone
+98 41 3339 3254
Fax
Email
vsarisarraf@yahoo.comsarraf@tabrizu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Tabriz
Full name of responsible person
Hamid Reza Zolfi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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