Protocol summary

Summary
Present study will perform in order to determine the effect of two weeks high-impact Aerobics training and Caffeine plus Coenzyme Q10 supplementation on exercise-induced response of capillary lactate and some serum enzymes in female athletes. Therefore, thirty-two elite female Aerobics athletes (age 20-28 years) will participate in a quasi-experimental repeated measured and double-blind design. The subjects will allocated in four randomized homogeneous groups. Placebo (Maltodexterine intake: 11 mg/kg/day), supplement group 1 (Caffeine intake: 6 mg/kg/day plus 5 mg/kg/day maltodextrine), supplement group 2 (Coenzyme Q10 intake: 5 mg/kg/day Q10 plus 6 mg/kg/day maltodexterine), supplement group 3 (Coenzyme Q10 plus Caffeine intake: 5 mg/kg/day Q10 plus 6 mg/kg/day Caffeine). All subjects will intake their capsules two times by day during Aerobics training protocol (11 exercise sessions) for two weeks. Blood samples will taken at three stages (30 minutes before first Aerobics session, 30 minutes before last Aerobics session, and 18- 24 hours after supplementation and training protocol). Biochemical markers (Creatine Kinase and Lactate Dehydrogenase: CK, LDH) and Capillary lactate will determine for all subjects.

General information

Acronym
CafQ10Fa2012
IRCT registration information
IRCT registration number: IRCT201305124663N13
Registration date: 2013-06-17, 1392/03/27
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-06-17, 1392/03/27
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
2012-12-30, 1391/10/10
Expected recruitment end date
2013-01-29, 1391/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of two-week high-impact Aerobics training and Caffeine plus Coenzyme Q10 supplementation on exercise-induced response of capillary lactate and some serum enzymes in female athletes
Public title
Anti-fatigue effect of Caffeine-Q10 supplementation
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion: Female; 20-28 year; healthy; Aerobics athletes; BMI <25; without any anti-inflammatory or medical drug such as caffeine >100 mg/day (during 6 months prior to the study) Exclusion: Diseases; Injuries; Uncontrolled intake of anti-inflammatory drugs during the period; Uncontrolled intake of stimulants during the period;
Age
From 20 years old to 28 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Golgasht St. Daneshgah St. Tabriz
City
Tabriz
Postal code
Approval date
2013-01-21, 1391/11/02
Ethics committee reference number
91193

Health conditions studied

1

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

Primary outcomes

1

Description
Total Serum Cereatine kinase (CK)
Timepoint
30 minutes before first Aerobics session; 30 minutes before last Aerobics session; and 18- 24 hours after supplementation and training protocol
Method of measurement
photometric methods with commercial kits (Bionik kit)

2

Description
Lactate Dehydrogenase
Timepoint
30 minutes before first Aerobics session; 30 minutes before last Aerobics session; and 18- 24 hours after supplementation and training protocol
Method of measurement
photometric methods with commercial kits (Bionik kit)

3

Description
Capillary Lactate
Timepoint
Before first and last session and after last session
Method of measurement
Scot lactometer

Secondary outcomes

1

Description
Blood Presure
Timepoint
30 minutes before every trainig session
Method of measurement
Aneroid blood pressure measurement

2

Description
Body Temperature
Timepoint
30 minutes before every training session
Method of measurement
Thermometer

Intervention groups

1

Description
The subjects in placebo group will intake 11 mg/kg/day maltodexterine for 2 weeks (11 sessions).
Category
Placebo

2

Description
The subjects in Q10 group will intake 5 mg/kg/day Q10 plus 6 mg/kg/day maltodexterine for 2 weeks (11 sessions).
Category
Treatment - Drugs

3

Description
The subjects in Caffeine group will intake 6 mg/kg/day caffeine plus 5 mg/kg/day maltodexterine for 2 weeks (11 sessions).
Category
Treatment - Drugs

4

Description
The subjects in CaQ10 group will intake 6 mg/kg/day Caffeine plus 5 mg/kg/day Q10 for 2 weeks (11 sessions).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Athletics Board of Tabriz Fitness
Full name of responsible person
Dr. Afshar Jafari
Street address
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Tabriz
Full name of responsible person
Dr. Rasoul Mohammad Rezaei
Street address
University of Tabriz
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. Afshar Jafari
Position
PH.D/ Associate professor of Exercise Physiology
Other areas of specialty/work
Street address
29 Bahman Ave. University of Tabriz, Faculty of Physical Education and Sport Sciences
City
Tabriz
Postal code
Phone
+98 41 1339 3251
Fax
Email
ajafari@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. Afshar Jafari
Position
PH.D/ Associate Professor of Exercise Physiology
Other areas of specialty/work
Street address
29 Bahman Ave. University of tabriz, Faculty of Physical Education and Sports Sciences
City
Tabriz
Postal code
Phone
+98 41 1339 3251
Fax
Email
ajafari@tabrizu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Tabriz
Full name of responsible person
Dr. Afshar Jafari
Position
PH.D/ Associate professor of Exercise Physiology
Other areas of specialty/work
Street address
29 Bahman Ave. University of Tabriz, Faculty of Physical Education and Sports Sciences
City
Tabriz
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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