Protocol summary

Summary
Objectives: Increased testosterone to cortisol ratio can have beneficial effects on body to combat stress improvement stamina and reduce fatigue. Among dietary antioxidants, selenium is one of the most important antioxidants.The effects of selenium supplementation on levels of testosterone, cortisol and testosterone to cortisol ratio of cyclist at rest and after exhaustive exercise, in relation to malondialdehyde are investigated in this study. Design, Setting and Conduct: The study included 8 male road cyclists. All subjects were supplemented with oral selenium selenite (200 μg/ d) for 4 weeks along with their normal diet.serum cortisol, testosterone, testosterone to cortisol ratio and malondialdehyde levels of subjects were determined at rest and exhausting, before and after selenium supplementation.Inclusions criteria: Having 3-4 years of exercise experience;the absence of any disease in the past month such as to cold;respiratory infection; Hungarian; and fever; the subjects hadn’t ingested any type of sport or vitamin-mineral supplements. Exclusions criteria; the consuming of sport or vitamin-mineral supplements; the use of alcohol and caffeine 48 hours before the test; participate in heavy exercise 48 hours before the test; exposure to disease. Intervention: Selenium supplementation and one bout of exhaustive exercise. Main Outcome Measures Variables: Free Testosterone, Cortisol, Malondialdehyde .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201110127754N2
Registration date: 2011-10-29, 1390/08/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-10-29, 1390/08/07
Registrant information
Name
Leila Shafiei Neek
Name of organization / entity
Faculty of Physical Education and Sport Sciences, University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 2258 9952
Email address
shafieineek@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2010-06-07, 1389/03/17
Expected recruitment end date
2010-08-21, 1389/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Selenium Supplementation on Anabolic Catabolic Ratio and Malondialdehyde in Athletes at Rest and after Exhaustive Exercise
Public title
Sport Nutrition
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusions criteria; Having 3-4 years of exercise experience;the absence of any disease in the past month such as to cold;respiratory infection; Hungarian; and fever; the subjects hadn’t ingested any type of sport or vitamin-mineral supplements. Exclusions criteria; the consuming of sport or vitamin-mineral supplements; the use of alcohol and caffeine 48 hours before the test; participate in heavy exercise 48 hours before the test; exposure to disease.
Age
From 20 years old to 30 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 8
Randomization (investigator's opinion)
N/A
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, Department of Physical Education.
Street address
Faculty of Physical Education and Sport Science of Tehran University, Northern Kargar Ave, Tehran, Iran.
City
Tehran
Postal code
Approval date
2010-05-26, 1389/03/05
Ethics committee reference number
20

Health conditions studied

1

Description of health condition studied
subjects were Healthy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
serum cortisol
Timepoint
before and after exhaustive exercise
Method of measurement
by Radioimmunoassay and Immunotech Kit

2

Description
Malondialdehyde
Timepoint
before and after exhaustive exercise
Method of measurement
by Spectrophotometery

Secondary outcomes

1

Description
no
Timepoint
no
Method of measurement
no

Intervention groups

1

Description
Placebo=200 micro gram dextrose
Category
Other

2

Description
selenium supplementation= 200 microgram as selenium selenite
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran City Cycling Traffic team
Full name of responsible person
Leila Shafiei Neek
Street address
City
Teharn

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Leila Shafiei Neek
Street address
Faculty of Physical Education and Sport Sciences, University of Tehran, Northern Kargar Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
Faculty of Physical Education and Sport Science
Full name of responsible person
Leila Shafiei Neek
Position
M.D
Other areas of specialty/work
Street address
Faculty of Physical Education and Sport Science of Tehran University, Northern Kargar Ave, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 912 447 1624
Fax
Email
shafieineek@ut.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Physical Education and Sport Science
Full name of responsible person
Leila Shafiei Neek
Position
M.D
Other areas of specialty/work
Street address
Faculty of Physical Education and Sport Science of Tehran University, Northern Kargar Ave, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 912 447 1624
Fax
Email
shafieineek@ut.ac.ir
Web page address

Person responsible for updating data

Contact

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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