Protocol summary

Summary
The purpose of the present study is to investigate Coenzyme Q10 and rock climbing effect on oxidative damages. A total of twenty elite male rock climbers in a randomized and double-blind design will be allocated in two equal groups: supplement (2.5 mg/kg/day Coenzyme Q10) and placebo (2.5 mg/kg/day dextrose) groups. After the supplementation period (14 days), all subjects will participate in an indoor exhaustive climbing protocol for 60 minutes. Blood samples will be obtained before the Q10 supplementation along with before and after the exhaustive exercise protocol. The serum total antioxidant capacity (TAC) and Malondialdehyde (MDA) will be measured by FRAP and spectrophotometer, respectively. The serum IL-6 and C-reactive protein will be determined by ELISA and immunophotometry methods, respectively. The peripheral blood leukocytes counts and CK activity will be determined by automatic analyzer and spectrophotometer, respectively.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201010114663N2
Registration date: 2011-07-22, 1390/04/31
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-07-22, 1390/04/31
Registrant information
Name
Afshar Jafari
Name of organization / entity
University of Tabriz
Country
Iran (Islamic Republic of)
Phone
+98 41 1339 3251
Email address
ajafari@tabrizu.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Tabriz
Expected recruitment start date
2010-09-12, 1389/06/21
Expected recruitment end date
2010-10-13, 1389/07/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of short-term coenzyme Q10 supplementation and one session of training on serum total antioxidant capacity, malondiadehyde and Creatine kinase in elite male rock climbers
Public title
Coenzyme Q10 and rock climbing effect on oxidative damages
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria: Healthy elite male rock climbers, age 19 -25 years, at least 3 years sport history, without any inflammatory or oxidative supplement ingestion during 6 months prior to the study, Exclusion criteria: chronic diseases, injuries, aerobic power lower than 50 ml/kg/min, fat percent higher than 10%
Age
From 19 years old to 25 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
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
2010-09-23, 1389/07/01
Ethics committee reference number
8927

Health conditions studied

1

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

Primary outcomes

1

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

2

Description
Serum Total antioxidant capacity (TAC)
Timepoint
14 day after the initiation of the intervention
Method of measurement
by Frap Method.

3

Description
Creatine Kinase Activity
Timepoint
14 day after the initiation of the intervention
Method of measurement
by automatic analyzer and spectrophotometer

Secondary outcomes

1

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

2

Description
Peripheral blood leukocytes counts
Timepoint
14 days
Method of measurement
It will determine by automatic analyzer

3

Description
Maximal Oxygen Consumption
Timepoint
14 day after the initiation of the intervention
Method of measurement
by Bruce treadmill protocol

Intervention groups

1

Description
Dextrose, 2.5 mg/kg/day, for 14 days, after the supplementation period (14 days), all subjects participate in an exhaustive indoor climbing training for 60 minutes.
Category
Placebo

2

Description
Q10, 2.5 mg/kg/day, for 14 days, after the supplementation period (14 days), all subjects participate in an exhaustive indoor climbing training for 60 minutes.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
University of Tabriz
Full name of responsible person
Dr Afshar Jafari
Street address
Faculty of physical education & sports sciences, University of Tabriz, 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Tabriz
Full name of responsible person
Dr Afshar Jafari
Position
PhD in Molecular 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 1339 3257
Fax
+98 41 1335 6008
Email
ajafari@tabrizu.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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