Protocol summary

Summary
Objectives: Conjugated linoleic acid (CLA) has anti-inflammatory, antioxidant, anticancer, anti-atherosclerosis, immune system improvement properties, and change of lipid metabolism. Therefore, it can play an important role in decrease of inflammation and increases body's antioxidant defenses. The aim of this study is investigation of consumption effect of CLA supplementation on oxidative stress and matrix metaloproteinases (MMPs) in young healthy men. Design: 30 healthy males with moderate physical activity will be selected into two groups (15 controls and 15 tests) at 18-30 years old. About 5.6 g CLA and 5.6 g oral paraffin supplementation will be given to test and control groups for 14 days, respectively. Exhaustive exercise session will be given to both groups at the end of 15th day. Setting and Conduct: Fasting blood samples will be taken for measurement of biochemical factors for both groups at the starting, before and after exhaustive exercise. Participants including major eligibility criteria: Young healthy males with moderate physical activity in 18-30 years old. Participants including major eligibility criteria: Individuals with certain diseases, smoking, alcoholism and other supplements, having certain dietary, professional training, sedentary and having 25<BMI<18.5 (body mass index) Kg/m2; Intervention: Conjugated linoleic acid (CLA) will be used for intervention. Variables: Superoxide dismutase, Glutathione peroxidase, Malondialdehyde, Interlukine-6, Tumor necrosis factor-alpha, Matrix metalloproteinase-2, Matrix metalloproteinase-9, High- sensitive C-reactive protein and other parameters.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201201035144N3
Registration date: 2013-06-25, 1392/04/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-06-25, 1392/04/04
Registrant information
Name
Ali Nemati
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3351 0052
Email address
a.nemati@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Ardabil University of Medical Sciences, Daneshgah Avenue, Ardabil, Iran.
Expected recruitment start date
2013-02-18, 1391/11/30
Expected recruitment end date
2013-03-18, 1391/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Consumption effects of conjugated linoleic acid (CLA) supplementation on oxidative stress and matrix metaloproteinases after exhaustive training in young healthy males men
Public title
Consumption effects of conjugated linoleic acid (CLA) supplementation on oxidative stress and matrix metaloproteinases following exercise in young healthy males
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria: Young healthy males with moderate physical activity in 18-30 years old. Exclusion criteria: Individuals with certain diseases, smoking, alcoholism and other supplements, having certain dietary, professional training, sedentary and having 25<BMI<18.5 (body mass index)Kg/m2.
Age
From 18 years old to 30 years old
Gender
Male
Phase
2-3
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

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Ardabil University of Medical Sciences
Street address
Ethic Committee of Ardabil University of Medical Sciences, Vice Chancellor for Research, Ardabil University of Medical Sciences, Ardabil University of Medical Sciences, Daneshgah Avenue, Ardabil, Iran
City
Ardabil
Postal code
5318985991
Approval date
2013-02-18, 1391/11/30
Ethics committee reference number
9102/5

Health conditions studied

1

Description of health condition studied
Healthy trained individuals
ICD-10 code
Z02.5
ICD-10 code description
Examination for participation in sport

Primary outcomes

1

Description
Exhaustion time
Timepoint
At the end of once training
Method of measurement
The signs and symptoms related to the complete exhaustion

Secondary outcomes

1

Description
Oral Paraffin
Timepoint
Two week
Method of measurement
Gram

2

Description
Height
Timepoint
At the beginning of intervention
Method of measurement
Stadiometers

3

Description
Weight
Timepoint
At the beginning of intervention
Method of measurement
Digital scales

4

Description
Malondialdehyde
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Spectrophotometry

5

Description
Total antioxidant capacity
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Spectrophotometry

6

Description
Superoxide dismutase
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Spectrophotometry

7

Description
Glutathione peroxidase
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Spectrophotometry

8

Description
Ascorbic acid
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Spectrophotometry

9

Description
Catalase
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Spectrophotometry

10

Description
Matrix metalloproteinase-2
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
ELISA

11

Description
Matrix metalloproteinase-9
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
ELISA

12

Description
Interlukine-6
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
ELISA

13

Description
Tumor Necrosis factor-alpha
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
ELISA

14

Description
hs-CRP
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Immunoturbidimetry

15

Description
Paraoxonase-1
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Spectrophotometry

16

Description
Fasting blood suger
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Spectrophotometry

17

Description
Arylesterase (ARE)
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Spectrophotometry

18

Description
HDL-Cholesterol
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Spectrophotometry

19

Description
LDL-Cholesterol
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Spectrophotometry

20

Description
Triglyceride
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Spectrophotometry

21

Description
Urea
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Spectrophotometry

22

Description
Creatinine
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Spectrophotometry

23

Description
Uric acid
Timepoint
At the beginning of intervention, previous and after exercise
Method of measurement
Spectrophotometry

24

Description
Bilirubin
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Spectrophotometry

25

Description
Calcium
Timepoint
At the beginning of intervention, previous and after exercise
Method of measurement
Spectrophotometry

26

Description
Complete blood count, hemoglobin and hematocrit
Timepoint
At the beginning of intervention, previous and after exercise
Method of measurement
Cell counter

27

Description
Copper
Timepoint
At the beginning of intervention, previous and after exercise
Method of measurement
Atomic absorptions spectrophotometry

28

Description
Zinc
Timepoint
At the beginning of intervention, previous and after exercise
Method of measurement
atomic absorption spectrophotometry

29

Description
Iron (Fe)
Timepoint
At the beginning of intervention, previous and after exercise
Method of measurement
Spectrophotometry

30

Description
Magnesium(Mg)
Timepoint
At the beginning of intervention, previous and after exercise
Method of measurement
spectrophotometry

31

Description
Ceruloplasmin(Cp)
Timepoint
At the beginning of intervention, previous and after exercise
Method of measurement
Spectrophotometry

32

Description
Phosphorus
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Spectrophotometry

33

Description
Leptin
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
ELISA

34

Description
Total Cholesterol
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Spectrophotometry

35

Description
Total protein
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Spectrophotometry

36

Description
Creatine phosphokinase(CK)
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Spectrophotometry

37

Description
Parathormone(PTH)
Timepoint
At the beginning of intervention, previous and after exercise
Method of measurement
ELISA

Intervention groups

1

Description
Given 5.6 gram/day CLA for14 days and once exhaustive exercise for intervention group.
Category
Other

2

Description
Giving 5.6 gram oral Paraffin to control group for 14 days and once exhausting exercise
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ardabil University of Medical Sciences
Full name of responsible person
Seyedyashar Alamolhoda
Street address
Biochemistry Dept, Faculty of Medicine, Ardabil University of Medical Sciences, Daneshgah Avenue, Ardabil, Iran.
City
Ardabil

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research Ardabil University of Medical Sciences
Full name of responsible person
Hadi Peeri
Street address
Vice Chancellor for Research Ardabil University of Medical Sciences, Ardabil University of Medical Sciences, Daneshgah Avenue, Ardabil, Iran.
City
Ardabil
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 Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Seyedyashar Alamolhoda
Position
Student of MSc
Other areas of specialty/work
Street address
Biochemistry Dept, Ardabil University of Medical Sciences, Ardabil University of Medical Sciences, Daneshgah Avenue, Ardabil, Iran.
City
Ardabil
Postal code
5155653466
Phone
+98 41 1657 8793
Fax
+98 45 1551 3776
Email
sy.alam@arums.ac.ir
Web page address
http//:www.arums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mohammad Mazani
Position
PhD of Clinical Biochemistry
Other areas of specialty/work
Street address
Biochemistry Dept, Faculty of Medicine, Ardabil University of Medical Sciences, Daneshgah Avenue, Ardabil, Iran
City
Ardabil
Postal code
5618953141
Phone
+98 45 1551 2788
Fax
+98 45 1551 3776
Email
m.mazani@arums.ac.ir
Web page address
http//:www.arums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mohammad Mazani
Position
PhD of Clinical Biochemistry
Other areas of specialty/work
Street address
Biochemistry Dept, Faculty of Medicine, University of Medical Sciences, Daneshgah Avenue, Ardabil, Iran
City
Ardabil
Postal code
5619853141
Phone
+98 45 1551 2788
Fax
+98 45 1551 3776
Email
m.mazani@arums.ac.ir
Web page address
http//:www.arums.ac.ir

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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