Protocol summary

Summary
In accordance with the limited studies about the effect of short and long-term creatine supplementation on exercise-induced physiological response, the present study will conduct to identify the effect of downhill running and creatine monohydrate loading on biochemical, inflammatory and performance indices of muscle soreness in male mountain climbers. Methods: Twenty male volunteer mountain climbers (aged 22-28 year, fat 8-12, and VO2max 50-55 ml/kg/min) in a quasi-experimental, randomized and double-blind design will allocate equally into supplement and placebo groups. Each participant will receive creatine monohydrate or dextrose (0.3 g/kg body weight/day) for five consecutive days (Loading Phase). After the supplementation period, all subjects will participate in one bout downhill running protocol on a treadmill (-15% incline) for 30 minutes with 65% heart rate reserve (HRR). Biochemical (Serum creatine kinase: CK), inflammatory (Peripheral blood leukocyte count; Serum C-reactive protein: CRP; interleukin-6: IL-6; Thigh circumference and perceived soreness) and performance indicators (Flexibility, maximal isometric strength and explosive power lower limb) will determine in both groups during four phases (baseline, after the supplement period, immediately and 24 hours after the exercise). Serum CK, CRP and IL-6 will measure by photometric, immunoturbidometric and ELISA assays (with commercial Pars-Azmoon and Bendermed kits), respectively. The peripheral blood leukocytes counts will determine by automatic analyzer. Muscle circumstance and perceived soreness will determine by flexible tap and Talag Scale, respectively. Flexibility, maximal isometric strength and explosive power of lower limb will determine by wells, dynamometric and sargent vertical jump tests, respectively.

General information

Acronym
Cra2010Etemadian
IRCT registration information
IRCT registration number: IRCT201011304663N4
Registration date: 2012-08-01, 1391/05/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-08-01, 1391/05/11
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
The Research will funded by Graduate office in University of Tabriz.
Expected recruitment start date
2010-05-26, 1389/03/05
Expected recruitment end date
2010-06-15, 1389/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of downhill running and creatine monohydrate loading on biochemical, inflammatory and performance indices of muscle soreness in male mountain climbers
Public title
Creatine effect on downhill running-induced damages
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria :Healthy males; mountain climbers; aged 22-28 years; BMI 18-22 Kg/m2; High jump more than 45 cm; aerobic power more than 50 ml/kg/min; at least 3 years sport history; without any anti-inflammatory and medical drugs during 6 months prior to the study. Exclusion criteria: chronic diseases; injuries; uncontrolled intake of oxidative supplements; uncontrolled intake of anti-inflammatory drugs or stimulants such as caffeine>100 mg/day (during the period).
Age
From 22 years old to 28 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

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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
2010-09-23, 1389/07/01
Ethics committee reference number
8929

Health conditions studied

1

Description of health condition studied
Downhill running-induced muscle damage
ICD-10 code
M79.1
ICD-10 code description
Myalgia

Primary outcomes

1

Description
C-reacive protein
Timepoint
Before and after 5-day creatine supplementation, 30 min before and immediately and 24 hours after downhill running protocol
Method of measurement
immunoturbidometric assay

2

Description
IL-6
Timepoint
Before and after 5-day creatine supplementation, 30 min before and immediately and 24 hours after downhill running protocol
Method of measurement
ELISA methods with commercial kits

3

Description
Total Serum Cereatine kinase (CK)
Timepoint
Before and after 5-day creatine supplementation, 30 min before and immediately and 24 hours after downhill running protocol
Method of measurement
Photometric methods with commercial kits (Pars-Azmoon)

4

Description
Peripheral blood leukocyte count
Timepoint
Before and after 5-day creatine supplementation, 30 min before and immediately and 24 hours after downhill running protocol
Method of measurement
It will determine by automatic analyzer.

5

Description
Perceived soreness
Timepoint
Before and after 5-day creatine supplementation, 30 min before and immediately and 24 hours after downhill running protocol
Method of measurement
Talag Scale

6

Description
Muscle circumstance
Timepoint
Before and after 5-day creatine supplementation, 30 min before and immediately and 24 hours after downhill running protocol
Method of measurement
It will determine by flexible tap

7

Description
Lower limb flexibility
Timepoint
Before and after 5-day creatine supplementation, 30 min before and immediately and 24 hours after downhill running protocol
Method of measurement
Sit and reach test (wells)

8

Description
Lower limb maximal isometric strength
Timepoint
Before and after 5-day creatine supplementation, 30 min before and immediately and 24 hours after downhill running protocol
Method of measurement
Dynamometric measurement

9

Description
Lower limb power
Timepoint
Before and after 5-day creatine supplementation, 30 min before and immediately and 24 hours after downhill running protocol
Method of measurement
Sargent vertical jump test

Secondary outcomes

1

Description
Peripheral blood lactate
Timepoint
Before and immediately after downhill running protocol
Method of measurement
It will determine by with commercial Randox kits

2

Description
Serum Total antioxidant capacity (TAC)
Timepoint
Before and after 5-day creatine supplementation, 30 min before and immediately and 24 hours after downhill running protocol
Method of measurement
by Frap Method.

3

Description
Serum Malondialdehyde
Timepoint
Before and after 5-day creatine supplementation, 30 min before and immediately and 24 hours after downhill running protocol
Method of measurement
by thiobarbituric acid reactive substance (TBARS) and spectrophotometer

Intervention groups

1

Description
Each participant will receive dextrose (0.3 g/kg body weight/day) for five consecutive days. After the supplementation period, all subjects will participate in one bout downhill running protocol on a treadmill (-15% incline) for 30 minutes with 65% heart rate reserve (HRR).
Category
Placebo

2

Description
Each participant will receive creatine monohydrate (0.3 g/kg body weight/day) for five consecutive days (Loading Phase). After the supplementation period, all subjects will participate in one bout downhill running protocol on a treadmill (-15% incline) for 30 minutes with 65% heart rate reserve (HRR).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
The mountain climbing Board of East Azerbaijan
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
Graduate office in 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
Graduate office in 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
University of Tabriz
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 3251
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
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