Protocol summary

Summary
The present study was conducted to assess the Effect of Aqueous Extract of Teucrium polium on oxidative stress in young athletes after graded maximal aerobic exercise. Hence, 24 physical education students in a randomized double-blind design were allocated into two supplement (Extract of Teucrium polium; n=12) & control (placebo; n=12) groups. The subjects ingested 125 gr/day/kg of Aqueous Extract or placebo 7 day before of exercise protocol. All subjects of both groups underwent in graded maximal aerobic exercise and to identify effect of 1 week consumption of Aqueous Extract of Teucrium polium blood samples were collected from the antcubital vein at: prior of supplementation, pre exercise, immediately after exercise and 24 h post exercise, and Malondiadehyde (MDA), plasma total antioxidant capacity (FRAP), superoxide dismutase (SOD) and 8-iso-Prostaglandin F2α (8-iso-PGF2α) were measured. All participants had to meet the following criteria before enrolment in the study: (1) No current chronic health problems, (2) Non-smokers, (3) No cardiovascular, metabolic or respiratory disease and (4) No consumption of any supplements or steroid anabolic drugs within the past 6 months.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012080610512N1
Registration date: 2013-02-25, 1391/12/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-02-25, 1391/12/07
Registrant information
Name
Sirvan Atashak
Name of organization / entity
Islamic Azad University-Mahabad Branch
Country
Iran (Islamic Republic of)
Phone
+98 44 2244 8301
Email address
s.atashak@iau-mahabad.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad Uiversity of Mahabad
Expected recruitment start date
2011-04-21, 1390/02/01
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Aqueous Extract of Teucrium polium on oxidative stress in young athletes after graded maximal aerobic exercise
Public title
Effect of Teucrium polium on oxidative stress indices in young athletes
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria: Males; young athlethes; aged 18-30years; No current chronic health problems; No consumption of any supplements or steroid anabolic drugs within the past 6 months Exclusion criteria: Smoking; injuries; acute diseases; and uncontrolled intake of any supplement or drugs (during the period).
Age
From 18 years old to 30 years old
Gender
Male
Phase
N/A
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
Clinical Research Ethics Committee of the Mahabad Islamic Azad University
Street address
Islamic Azad University, Mahabad Branch, university Street, Mahabad, Iran
City
Mahabad
Postal code
Approval date
2011-04-13, 1390/01/24
Ethics committee reference number
پ1-90

Health conditions studied

1

Description of health condition studied
oxidative stress
ICD-10 code
Z50.1
ICD-10 code description
other physical therapy

Primary outcomes

1

Description
oxidative stress indices (MDA, FRAP, SOD, 8-iso-PGF2α )
Timepoint
prior of supplementation, pre exercise, immediately after exercise and 24 h post exercise
Method of measurement
The total antioxidant capacity of plasma was evaluated by applying the FRAP assay (ferric reducing antioxidant power or ferric reducing ability of plasma). Moreover, Plasma malondialdehyde (MDA) concentrations spectrophotometrically were assayed by measurement of thiobarbituric acid reactive substances (TBARS) assay. Serum 8-iso-PG F2α and Superoxide Dismutase (SOD) levels were measured with a commercially available kit

Secondary outcomes

1

Description
lipid profile
Timepoint
prior of supplementation, pre exercise, immediately after exercise and 24 h post exercise
Method of measurement
The lipid profile will determine by serum levels of total cholesterol (TC), high-density cholesterol (HDL-C), low-density cholesterol (LDL-C) and triglycerides (TG) using the enzymatic method

2

Description
Homosysteine
Timepoint
prior of supplementation, pre exercise, immediately after exercise and 24 h post exercise
Method of measurement
It determined by ELISA methods with commercial kits.

Intervention groups

1

Description
The subjects in the supplemented group were given prepared aqueous extract of Teucrium polium (125 ml/kg/day), 7 day before of aerobic exercise protocol
Category
Placebo

2

Description
subject in placebo group also received 125 gr/day/kg of placebo 7 day before of aerobic exercise protocol.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University of Mahabad
Full name of responsible person
Dr Sirvan Atashak
Street address
West Azerbaijan-Mahabad-Islamic Azad University
City
Mahabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad university of mahabad
Full name of responsible person
Dr Akbar Ghassemi Kahrizeh
Street address
Islamic Azad university of mahabad
City
Mahabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad university of mahabad
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
Department of Physical Education & Sports Science, Azad University, Mahabad Branch, university Stree
Full name of responsible person
Dr Sirvan Atashak
Position
Assistant Professor of exercise physiology
Other areas of specialty/work
Street address
Islamic Azad University, Mahabad Branch, university Street, Mahabad, Iran
City
Mahabad
Postal code
Phone
+44 22341002
Fax
Email
s.atashak@iau-mahabad.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Physical Education & Sports Science, Islamic Azad University, Mahabad Branch, universi
Full name of responsible person
Dr Sirvan Atashak
Position
Ph.D
Other areas of specialty/work
Street address
Islamic Azad University, Mahabad Branch, university Street, Mahabad, Iran
City
Mahabad
Postal code
Phone
+44 22341002
Fax
Email
s.atashak@iau-mahabad.ac.ir; atashak_sirvan@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University of Mahabad
Full name of responsible person
Dr Sirvan Atashak
Position
Assistant Professor of exercise physiology
Other areas of specialty/work
Street address
Department of Physical Education & Sports Science, Azad University, Mahabad Branch, university Street, Mahabad, Iran
City
Mahabad
Postal code
Phone
+98 44 2244 8301
Fax
Email
s.atashak@iau-mahabad.ac.ir
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
Loading...