Protocol summary

Summary
The aim of this study is to evaluate the effect of L-carnitine supplementation on physical fatigue in athletes with history of bodybuilding. In this study, 30 men 18-40 years old with history of at least 1 year of bodybuilding activity around 3 hours a week without smoking and diseases that are effective in athletic power (such as asthma, anemia, cancer) will be divided into 2 groups randomly (Each group consists of 15 people). The first group will receive 1.5 grams of L-carnitine for 2 weeks (3 capsules per day). The second group will receive starch in the same duration and the same dose. At the end of the study physical fatigue level will be assessed using visual analogue scale (VAS) before and after exercise in 2 groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201110133320N4
Registration date: 2012-03-29, 1391/01/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-03-29, 1391/01/10
Registrant information
Name
Mehrangiz Ebrahimi mamagani
Name of organization / entity
Health & Nutrition faculty of Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 1113
Email address
ebrahimimamagani@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Students Research Committee, Vice chancellor for research and technology, Tabriz University of Medical Sciences
Expected recruitment start date
2012-01-20, 1390/10/30
Expected recruitment end date
2012-02-04, 1390/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral L-carnitine supplementation on physical fatigue in bodybuilders
Public title
The effect of oral L-carnitine supplementation on physical fatigue in bodybuilders
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: men, 18-40 years old; history of at least 1 year of bodybuilding activity around 3 hours a week. Exclusion criteria: smoking; consumers of vitamin, nutritional and mineral supplement; consumers of drug; diseases that are effective in athletic power (such as asthma, anemia, cancer).
Age
From 18 years old to 40 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences
City
Tabriz
Postal code
5166614711
Approval date
2011-12-26, 1390/10/05
Ethics committee reference number
5/4/7637

Health conditions studied

1

Description of health condition studied
Physical fatigue
ICD-10 code
T73.3
ICD-10 code description
Exhaustion due to excessive exertion

Primary outcomes

1

Description
Physical fatigue
Timepoint
Before and after the intervention
Method of measurement
The standard questionnaire Visual Analog Scale

Secondary outcomes

empty

Intervention groups

1

Description
1.5 grams of L-carnitine for 2 weeks (3 capsules per day)
Category
Treatment - Drugs

2

Description
starch in the same duration and the same dose
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Erfan Club gym
Full name of responsible person
Amin Sabari
Street address
Rudaki Street
City
Urmia

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Students Research Committee, Vice chancellor for research and technology, Tabriz University of Medic
Full name of responsible person
Dr. Piruzpanah
Street address
Health & Nutrition Faculty, Golgasht street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Students Research Committee, Vice chancellor for research and technology, Tabriz University of Medic
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
Food and Drug Administration, Urmia University of Medical Sciences
Full name of responsible person
Zahra Zeinalabedinzade Sore
Position
Bachelor of Science in nutrition
Other areas of specialty/work
Street address
Food and Drug Administration، Shahid Golipur Street
City
Urmia
Postal code
Phone
+98 44 1277 2023
Fax
Email
z.zeinalabedinzade@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mehranghiz Ebrahimi Mamagani
Position
PhD of nutrition, Associated professor
Other areas of specialty/work
Street address
Health & Nutrition faculty, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
ebrahimimamagani@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hamed Fazlmand/ Manager
Position
Bachelor of Science in nutrition
Other areas of specialty/work
Street address
Health and Nutrition faculty, Golgasht Street
City
Tabriz
Postal code
Phone
Fax
Email
h.fazlmand@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
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