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The effects of carnitine and caffeine supplementation on body fat percentage, oxidative stress, lipid profile, inflammatory and atherosclerotic factors in semi-professional athletes

Protocol summary

Summary
The aim of this study is to investigate the effects of caffeine itself and with carnitine supplementation to find out their synergistic effects on weight changes, body fat percent, and also possible side effects on oxidative stress and cardiovascular health. For this purpose, 30 male soccer players will be categorized into 3 groups (n=10). First group will ingest caffeine (6 mg/kg), second group will ingest caffeine with carnitine (2 g/day), and the 3rd group will ingest placebo for 6 weeks, on their usual training days (3 days/week). To monitor each subject’s food intake, 24 hour recall questionnaire will be used. During the initial visit, height, weight and Vo2max will be measured and fasting blood samples will be obtained to determine lipid profile (TG, T-C, HDL, LDL), FFA, Glucose, Creatine kinase, malondialdehyde, leptin, TNF-α and CRP levels. After 6 weeks of supplementation and usual training sessions, the above mentioned factors will be measured once again.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014100619411N1
Registration date: 2014-10-15, 1393/07/23
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-10-15, 1393/07/23
Registrant information
Name
Saeed Shirali
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8319
Email address
shirali-s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Nutritional and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2014-11-06, 1393/08/15
Actual recruitment start date
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Actual recruitment end date
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Trial completion date
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Scientific title
The effects of carnitine and caffeine supplementation on body fat percentage, oxidative stress, lipid profile, inflammatory and atherosclerotic factors in semi-professional athletes
Public title
Effects of caffeine and carnitine in athletes
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Male athletes aged 20 to 30 years old; playing soccer for approximately 2 years; body mass index in the normal range; without cardiovascular disease and muscular damage Exclusion criteria: weight loss diet over the past month, consumption of any sport supplements 8 weeks before the study, having acute and chronic illnesses, smoking
Age
From 20 years old to 30 years old
Gender
Male
Phase
N/A
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
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan, Ahvaz
City
Ahvaz
Postal code
6135715794
Approval date
2014-09-27, 1393/07/05
Ethics committee reference number
1393.191

Health conditions studied

1

Description of health condition studied
Athletes
ICD-10 code
Z10.3
ICD-10 code description
Routine general health check-up of sports teams

Primary outcomes

1

Description
weigth changes
Timepoint
Before and after intervention
Method of measurement
Weight scale

2

Description
Body fat percentage
Timepoint
Before and after intervention
Method of measurement
Body fat Analyser

3

Description
Oxidative stress
Timepoint
Before and after intervention
Method of measurement
ELISA method

4

Description
Cardiovascular health: lipid factors(TG.TC,HDL,LDL),Fasting glucose, Free fatty acids, CRP
Timepoint
Before and after intervention
Method of measurement
ELISA and Spectrophotmetery methods

Secondary outcomes

empty

Intervention groups

1

Description
Caffeine supplementation in gelatinized capsules, 6 mg/kg, 3 times per week, for 6 weeks
Category
Treatment - Drugs

2

Description
Carnitine supplementation in gelatinized capsules, 2 g/kg, 3 times per week, for 6 weeks
Category
Treatment - Drugs

3

Description
Placebo (dextrose) in gelatinized capsules, 2 g/kg, 3 times per week, for 6 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Khuzestan Province Football Association
Full name of responsible person
Damoon Ashtary
Street address
Khuzestan Province Football Association, Ahvaz, Khuzestan
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr.Seyed Ahmad Hosseini
Street address
Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Golestan
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr.Saeed Shirali
Position
Ph.D of Clinical Biochemistry
Other areas of specialty/work
Street address
Drpartment of Laboratory Sciences, Ahvaz Jundishapur University of Medical Sciences, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1373 8319
Fax
Email
shirali-s@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Sevana Daneghian
Position
PhD student of nutrition
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1373 8319
Fax
Email
sevana_d@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Dr.Saeed Shirali
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 61 1373 8285
Fax
Email
shirali-s@ajums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
empty
Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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