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Compare the effect of diet and concurrent supplementation conjugated linoleic acid and omega-3 in endurance athletes

Protocol summary

Summary
In this double blind randomized clinical trial, 60 male athletes were chosen and randomly divided into four groups, receiving: a) dietary intervention (CHO:50-65%, PRO:15-25%, FAT:25-30%); b) CLA(4g/d), c) CLA(4g/d) and omega-3(1g/d) and d) placebo (n = 15), for 6 weeks. Inclusion criteria: age between 18 and 35 years old; absence of liver diseases, cardiovascular or muscular, skeletal and pulmonary problems; no consumption of sports supplements during the 3 months before the study. Exclusion criteria: history of any patient during the study; consumption of sports supplements during the study period. Additionally, indices of oxidative stress, body composition, 24-hour dietary recall were measured in two stages: before the supplementation and after it. Furthermore, anaerobic and aerobic performance of athletes were measured by the Wingate test and Astrand. Data were analyzed using version 16 of SPSS/PC statistical package.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201312223236N5
Registration date: 2013-12-28, 1392/10/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-12-28, 1392/10/07
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
2013-08-23, 1392/06/01
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effect of diet and concurrent supplementation conjugated linoleic acid and omega-3 in endurance athletes
Public title
The effect of diet and CLA plus Omega-3 supplementation on aerobic and anaerobic performance, oxidative stress, body mass in endurance athletes
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: age between 18 and 35 years od; absence of liver diseases; cardiovascular or muscular, skeletal and pulmonary problems; no consumption of sports supplements during the 3 months before the study. Exclusion criteria: history of any patient during the study; consumption of sports supplements during the study period.
Age
From 18 years old to 35 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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
Zand Street-headquarters of Shiraz University of Medical Sciences
City
Shiraz
Postal code
1978-71345
Approval date
2013-08-19, 1392/05/28
Ethics committee reference number
CT-92-6679

Health conditions studied

1

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

Primary outcomes

1

Description
Anerobic performance
Timepoint
Pre-post intervention
Method of measurement
Monark-ergomedic-894e

2

Description
Aerobic performance
Timepoint
Pre-post intervention
Method of measurement
Monark-ergomedic 928-e

3

Description
Malondialdehyde(MDA)
Timepoint
Pre-post intervention
Method of measurement
Spectophotometry

4

Description
Body mass index
Timepoint
Pre-post intervention
Method of measurement
( BIA ) Bodystat Quadscan 4000

Secondary outcomes

1

Description
weight body
Timepoint
pre-post intervention
Method of measurement
Digital scale

Intervention groups

1

Description
dietary intervention (CHO:50-65%,PRO:15-25%,FAT:25-30%),
Category
Other

2

Description
CLA(4g/d) for a period of 6 weeks
Category
Other

3

Description
CLA(4g/d), -omega-3(1g/d)for a period of 6 weeks
Category
Other

4

Description
placebo for a period of 6 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Provincial Sports Complex in Shiraz
Full name of responsible person
Amin Ajdari - Master of Exercise Physiology
Street address
Lane 3- Nyash Street-- Chamran Blvd-Cultural, educational, sports and recreational complex in the province-Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Council of Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Hatem
Street address
Red Crescent side- Zand Street - headquarters of Shiraz University of Medical Sciences-Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of 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
Shiraz University of Medical Sciences - Department of Nutrition and Food Sciences
Full name of responsible person
Saheb Abbas Torki
Position
MSc of nutrition
Other areas of specialty/work
Street address
fatolmobin st-zhara Blvd- Department of Nutrition and Food Sciences-Shiraz
City
Shiraz
Postal code
7153675541
Phone
+98 916 404 3401
Fax
Email
sahebnut@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences, Department of Nutrition and Food Sciences
Full name of responsible person
Zohreh Mazloom
Position
Associate Professor of Nutrition
Other areas of specialty/work
Street address
fatolmobin st-zhara Blvd- Department of Nutrition and Food Sciences-Shiraz
City
Shiraz
Postal code
7153675541
Phone
+98 71 1725 1001
Fax
Email
zohreh.mazloom@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences- Department of Nutrition and Food Sciences
Full name of responsible person
Saheb Abbas Torki
Position
MSc of nutrition
Other areas of specialty/work
Street address
fatolmobin st-zhara Blvd- Department of Nutrition and Food Sciences-Shiraz
City
Shiraz
Postal code
7153675541
Phone
Fax
Email
sahebnut@yahoo.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
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