Protocol summary

Summary
This study was a randomized and single blind clinical trial to determine the effects of creatine and carnitine supplementation on anaerobic performance, energy metabolism (lactic acid, TG), interleukin-6, malondialdehyde, glutathione peroxidase, BUN, blood creatinine and creatinine 24 hour urine in athletes martial. 48 male athletes who have just started this sport at the age between 18 to 30 years, no history of liver disease, cardio - vascular problems, muscular - skeletal, lung, and not receiving protein supplement during the past few months to be reviewed are. A candidate's consent to participate in this study was fulfiiled. During the supplementation period (4 weeks) someone with a cold or diarrhea, are excluded. Volunteers randomly divided into 4 groups of 12 people are following: athletes with creatine supplementation ( 0.3 g / kg / d for 7 days and 0.03 g / kg / d , followed by 21 days); athletes with carnitine supplementation ( 2 g / d for every 28 days); athletes and carnitine supplementation with creatine supplementation (0.3 g / kg / d for 7 days and 0.03 g / kg / d for 21 days followed by addition 2 g / d for each person for 28 days ) and athletes receiving placebo. Beginning and end of the performance indicators anaerobic, lactate, TG, IL-6, malondialdehyde and glutathione peroxidase, BUN, creatinine, and creatinine 24 hour urine were measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201203063236N3
Registration date: 2012-03-14, 1390/12/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-03-14, 1390/12/24
Registrant information
Name
Zohreh Mazloom
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1008
Email address
zmazloom@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2011-12-11, 1390/09/20
Expected recruitment end date
2012-01-10, 1390/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of creatine and carnitine supplementation on anaerobic performance, energy metabolism, inflammatory markers, oxidative stress and kidney function in athletes
Public title
Effects of creatine supplementation in athletes
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: male athletes, martial artist who recently have started this exercise. Age between 18 and 30 years, no history of liver disease, cardio - vascular or muscular problems - musculoskeletal, pulmonary, and not receiving any type of protein supplement during the last few months. Exclusion criteria from the study: During the supplementation period, someone with a cold or diarrhea will be excluded
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: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Central Medical Building, Zand Avenue, PO Box =978-71345, Shiraz
City
Shiraz
Postal code
1978 _71345
Approval date
2011-11-19, 1390/08/28
Ethics committee reference number
5810 - 90 - CT

Health conditions studied

1

Description of health condition studied
Athletes
ICD-10 code
Z10
ICD-10 code description
Routine general health check-up of defined subpopulation

Primary outcomes

1

Description
Anaerobic performance
Timepoint
Before and after intervention
Method of measurement
Menarche bike model E894

2

Description
Triglyceride
Timepoint
Before and after intervention
Method of measurement
Colorimetric method with an autoanalyzer system

3

Description
Lactic Acid
Timepoint
Before and after intervention
Method of measurement
Spectrophotometrically with spectrophotometry

4

Description
interleukin-6
Timepoint
Before and after intervention
Method of measurement
Spectrophotometry with RIA

5

Description
Glutathione peroxidase
Timepoint
Before and after intervention
Method of measurement
ELISA using ELISA kits

6

Description
malondialdehyde
Timepoint
Before and after intervention
Method of measurement
Spectrophotometrically with spectrophotometry

7

Description
Creatinine
Timepoint
Before and after intervention
Method of measurement
Colorimetric method with an autoanalyzer system

8

Description
BUN
Timepoint
Before and after intervention
Method of measurement
Colorimetric method with an autoanalyzer system

9

Description
24-hour urine creatinine
Timepoint
Before and after intervention
Method of measurement
Colorimetric method with an autoanalyzer system

Secondary outcomes

1

Description
Overweight
Timepoint
Before and after intervention
Method of measurement
By Libra

2

Description
Weight loss
Timepoint
Before and after intervention
Method of measurement
By Libra

Intervention groups

1

Description
Placebo (MCC mixed with cellulose) 8 g daily (4 times daily) for 28 days
Category
Placebo

2

Description
Supplementation with creatine and carnitine ( 0.3 g / kg / d to 7 days, and 0.03 g / kg / d to 21 days followed by addition 2 g/d for every 28 days)
Category
Other

3

Description
20 to 30 grams of creatine monohydrate supplementation (0.3 grams per kilogram of body weight) for 7 days (loading period) 2 to 5 grams to 21 days later (maintain period)
Category
Other

4

Description
Carnitine supplementation 2 g daily for 28 days
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Velayat Sport Center
Full name of responsible person
Amin Azhdari, MSc in Exercise Physiology
Street address
Shiraz, Chamran Blvd, St Niayesh, Velayat Sport
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Dr Mohammad Ali Sahmeddini
Street address
Zand Ave, University of Central Building
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz university of medical sciences
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
School of health & nutrition, Shiraz University of Medical Sciences
Full name of responsible person
Bahman Panahandeh
Position
MSc student of nutrition
Other areas of specialty/work
Street address
Department of nutrition, School of health & nutrition,Shiraz University of Medical Sciences
City
Shiraz
Postal code
7153675541
Phone
+98 71172510018
Fax
Email
panahande.b@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Zoher Mazloom
Position
PhD of nutrition, Assistant professor of nutrition department
Other areas of specialty/work
Street address
Department of nutrition, School of health & nutrition, Shiraz University of Medical Sciences
City
Shiraz
Postal code
7153675541
Phone
+98 71 1725 1008
Fax
Email
zohreh_mazloom@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Bahman Panahandeh
Position
MSc student of nutrition
Other areas of specialty/work
Street address
School of health & nutrition, Shiraz university of Medical Sciences
City
Shiraz
Postal code
Phone
Fax
Email
panahande.b@gmail.com
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...