Protocol summary

Summary
In this randomize, double-blind, placebo-controlled trial, 80 healthy men (20-27years old students living in our University dorm who eat same food as the University serves) will randomly be assigned into two groups. One group will receive 3.2 g active conjugated linoleic acids daily as 4 capsules (each 1 g containing 80% or 0.8 g active conjugated linoleic acids) for two months. The conjugated linoleic acids capsules consists of two main isomers: cis-9, trans-11 CLAs and trans-10, cis-12 triglyceride type. Second group will similarly receive 4 capsules daily (soyflower oil) as placebo, during this two months. The objective is, to investigate the effect of conjugated linoleic acids on endurance exercise, resistance exercise, body composition and blood pressure in healthy men. At baseline and endpoint of the intervention, maximal oxygen consumption, ventilatory thresholds will measure in bruce test (Cosmed, Fitmate, Italy). Muscular strength will measure by Hand grip. Body weight, body fat mass, and lean body mass will measure by BIA method (Body state, Quadscan 4000, Multi scan 5000). Abdominal fat will measure with viscan (abdominal fat analyzer). The systolic (SBP) and diastolic blood pressure (DBP) will measure after five minutes rest. Then the measurements will be entered in SPSS (17.0) and analyzed using this software to compare two groups in order to investigate the effect of CLA on the above parameters.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201204159472N2
Registration date: 2012-10-27, 1391/08/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-10-27, 1391/08/06
Registrant information
Name
Naheed Aryaeian
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4750
Email address
aryaeian.n@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences, School of public health- research affaires and educational affaires
Expected recruitment start date
2012-10-22, 1391/08/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of conjugated linoleic acid supplementation on, maximum oxigen consumption, resistance exercise, body composition and blood pressure in men.
Public title
The effect of conjugated linoleic acid supplementation on exercise performance
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Participants must be male and the student of Tehran University of Medical Science; Age range must be 20-27 years; at least from 2 months ago Living in dormitories and stay more than 3 months; willingness to cooperate; Typically use distributed food in the dormitory and the university; BMI range must be 20-27; fat mass must be less than 25%; Moderate caffeine consumer. Not affected by Cardiovascular disease, musculoskeletal disorders or metabolic disease;No allergic to metals; No cigarette smoking hookah pipe and ... More than once a month; Resting systolic blood pressure less than140 or diastolic less than 90; No consumption doping drugs, supplements and drugs; No sports injuries that can affect a person's physical performance; physical activity based on individual physical activity questionnaire ipaq be low or moderate. exclusion criteria: Inability to reach the respiratory gas exchange ratio equal to 1 in the final exercise test; Any use of supplements during the study; Unwillingness to cooperate in research; Failure to correct use of supplements (use supplement less than 80 percent); Any change in diet or physical activity daily rate during the study.
Age
From 20 years old to 27 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics commitee in research of Tehran university of Medical Sciences
Street address
Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd, Tehran, Iran
City
Tehran
Postal code
14174
Approval date
2012-07-30, 1391/05/09
Ethics committee reference number
91-01-27-16706-59730

Health conditions studied

1

Description of health condition studied
healthy volunteers
ICD-10 code
Z01.9, Z00
ICD-10 code description
Special examination, unspecified, General examination and investigation of persons without complaint and reported diagnosis

Primary outcomes

1

Description
Maximum oxygen consumption
Timepoint
before intervention, two month after intervention
Method of measurement
fitmate

2

Description
time to exhausion
Timepoint
before intervention and two month after intervention
Method of measurement
fitmate

3

Description
Running Distance
Timepoint
before intervention and two month after intervention
Method of measurement
treadmil

4

Description
Muscle strength
Timepoint
before intervention and two month after intervention
Method of measurement
hand grip

5

Description
weight
Timepoint
before intervention and two month after intervention
Method of measurement
scale

6

Description
Waist
Timepoint
before intervention and two month after intervention
Method of measurement
tape measure

7

Description
abdominal fat
Timepoint
before intervention and two month after intervention
Method of measurement
viscan

8

Description
% fat mass
Timepoint
before intervention and two month after intervention
Method of measurement
bioelectrical impedance analysis

9

Description
% free fat mass
Timepoint
before intervention and two month after intervention
Method of measurement
bioelectrical impedance analysis

10

Description
systolic blood pressure
Timepoint
before intervention and two month after intervention
Method of measurement
manometer

11

Description
diastolic blood pressure
Timepoint
before intervention and two month after intervention
Method of measurement
manometer

Secondary outcomes

empty

Intervention groups

1

Description
The control group take 3 capsules daily
Category
Placebo

2

Description
intervention group take 3 capsules daily
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Enghlab dormitory
Full name of responsible person
Dr. Nhid Aryaeian
Street address
Enghlab dormitory, Enghlab square, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd, Tehran, Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for research, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Milad Tajmanesh
Position
Master student
Other areas of specialty/work
Street address
Enghlab dormitory, Kargar street, Enghlab square, Tehran
City
Tehran
Postal code
14174
Phone
00
Fax
Email
miladtajmanesh@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Milad Tajmanesh
Position
Master student
Other areas of specialty/work
Street address
Enghlab dormitory, Kargar street, Enghlab square, Tehran
City
Tehran
Postal code
14147
Phone
00
Fax
Email
miladtajmanesh@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Milad Tajmanesh
Position
Master student
Other areas of specialty/work
Street address
Enghlab dormitory, Kargar street, Enghlab square, Tehran
City
Tehran
Postal code
14147
Phone
00
Fax
Email
miladtajmanesh@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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