Protocol summary

Summary
Objectives: Today, oxidative stress as a predisposing factor in the pathogenesis of Chronic Obstructive Pulmonary Disease is known, although the correlation between chronic obstructive pulmonary diseases with antioxidants remains unclear. Design: So this study was to evaluate the effect of conjugated linoleic acid (CLA), as an antioxidant, on serum level of malondialdehyde (MDA),matrix metallopeptidase 1(MMP1), matrix metallopeptidase 2(MMP2), Leptin,Sirtuin 1,Interleukin 6 and Interleukin-1 beta (IL1β) as bio-marker for oxidative stress occurs. Setting and conduct: This double-blind prospective study on ninety cases of chronic obstructive pulmonary disease at the interval January 2015 to December 2015 in Imam Khomeini hospital in Ardebil is done. The provided forms containing demographic information, Chronic obstructive pulmonary disease Assessment Test (CAT), modified dyspnea scale (MMRC) and appetite questionnaire is completed. Then, spirometry and six-minute walk test is done. Then 3 cc of blood from patients to measure serum levels of Interleukin-1beta, malondialdehyde, matrix metallopeptidase 1(MMP1), matrix metallopeptidase 2(MMP2), Leptin,Sirtuin 1,Interleukin 6 and serum total antioxidant capacity is taken. Participants including major eligibility criteria: inclusion criteria include Chronic Obstructive Pulmonary Disease patients aged between 40-80؛ clinically stable disease with FEV1 less than 75% predict and exclusion criteria include female؛ any associated chronic diseases such as CAD and CKD...؛receiving any interacting drugs؛ abnormal chest x ray Intervention: The original drug (conjugated linoleic acid 3.2 g, soft gel 800mg four times in day) and placebo (soft gel four times in day) in equal numbers will be packed in similar package. Packets from one to ninety-numbered and randomly given to patients for six weeks.Six weeks after the intervention, again COPD Assessment Test (CAT), dyspnea scale (MMRC) and appetite completed questionnaires, spirometry and six-minute walking test was performed for the second time. During the intervention, the patient closely for possible side effects and medication use are followed. Main outcome measures (variables): blood sampling is repeated for matrix metallopeptidase 1(MMP1), matrix metallopeptidase 2(MMP2), Leptin, malondialdehyde (MDA) and Interleukin-1 beta (IL1β),Sirtuin 1,Interleukin 6 and total antioxidant capacity. Before entering the study, written informed consent was obtained from all patients

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015080823559N1
Registration date: 2015-09-27, 1394/07/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-09-27, 1394/07/05
Registrant information
Name
Somaieh Matin
Name of organization / entity
Ardabil University of Medicine Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3373 3011
Email address
s.matin@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ardabil University of Medical Sciences
Expected recruitment start date
2015-01-01, 1393/10/11
Expected recruitment end date
2015-12-30, 1394/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Conjugated linoleic acid supplemented diet on nutritional status, and oxidative stress in Chronic Obstructive Pulmonary Disease patients
Public title
Effect of Conjugated Linoleic Acid supplemented diet on oxidative stress in Chronic Obstructive Pulmonary Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Chronic Obstructive Pulmonary Disease patients aged between 40-80؛ clinically stable disease with FEV1 less than 75% predict. Exclusion criteria:female؛ any associated diseases such as CAD and CKD ..؛ receiving any interacting drugs؛ abnormal chest x ray
Age
From 40 years old to 80 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ardabil University of Medicine Sciences Ethics committee
Street address
Ardabil University of Medicine Sciences, Daneshgah street, Ardabil
City
Ardabil
Postal code
53141-56198
Approval date
2015-01-18, 1393/10/28
Ethics committee reference number
9116

Health conditions studied

1

Description of health condition studied
Chronic Obstructive Pulmonary Disease
ICD-10 code
J40, J41,
ICD-10 code description
Chronic Lower Respiratory Diseases

Primary outcomes

1

Description
malondialdehyde (MDA) serum level
Timepoint
At the beginning of study and 6 weeks after intervention
Method of measurement
Lab.

2

Description
IL1β serum level
Timepoint
At the beginning of study and 6 weeks after intervention
Method of measurement
Lab.

3

Description
Total Antioxidan Capacity
Timepoint
At the beginning of study and 6 weeks after intervention
Method of measurement
Lab.

4

Description
matrix metallopeptidase 1 serum level(MMP1)
Timepoint
At the beginning of study and 6 weeks after intervention
Method of measurement
Lab.

5

Description
matrix metallopeptidase 2 (MMP2) serum level
Timepoint
At the beginning of study and 6 weeks after intervention
Method of measurement
Lab.

6

Description
Leptin serum level
Timepoint
At the beginning of study and 6 weeks after intervention
Method of measurement
Lab.

7

Description
Added at 2017-11-01: Sirtuin 1
Timepoint
Added at 2017-11-01: before and after intervention
Method of measurement
Added at 2017-11-01: ELISA

8

Description
Added at 2017-11-01: Interleukin 6
Timepoint
Added at 2017-11-01: At the beginning of study and 6 weeks after intervention
Method of measurement
Added at 2017-11-01: Lab

Secondary outcomes

1

Description
CLA side effects
Timepoint
At the beginning of study and 6 weeks after intervention
Method of measurement
patient

Intervention groups

1

Description
treatment intentervention with conjugated linoleic acid 3.2 g(soft gel 800mg four times in day) for six weeks
Category
Treatment - Drugs

2

Description
Placebo soft gel four times in day for six weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Somaieh Matin
Street address
Imam Khomeini Hospital, Shahid Jeddi Street, Ardabil
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
Dr Shahram Habibzadeh
Street address
Ardabil University of Medical Science, Daneshgah street, 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
Somaieh Matin
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Department of Internal Medicine, Imam Khomeini Hospital, Ardabil University of Medical Science, Ardabil, Iran
City
Ardabil
Postal code
5615783134
Phone
+98 45 3373 3011
Fax
Email
s.matin@arums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
DR. Hassan Ghobadi
Position
Pulmunologist,Internal Medicine Department
Other areas of specialty/work
Street address
Internal Medicine Department, Imam Khomeini Hospital, Shahid Jeddi street, Ardabil
City
Ardabil
Postal code
53141- 56198
Phone
+98 45 3325 1410
Fax
+98 33510057
Email
h.ghobadi@arums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Somaeih Matin
Position
Internal Medicine Asisstant
Other areas of specialty/work
Street address
Department of Internal Medicine, Imam Khomeini Hospital, Ardabil University of Medical Science, Ardabil, Iran
City
Ardabil
Postal code
5615783134
Phone
+98 45 3373 3011
Fax
Email
s.matin@arums.ac.ir
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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