Effect of omega-3 fatty acids supplementation on serum levels of malondialdehyde, total antioxidant capacity and paraoxonase1 in polycystic ovary syndrome patients
This study was a randomized single-blind placebo controlled trial on 60 women with polycystic ovary syndrome. Total purpose of this study was to determine the effect of omega-3 fatty acids supplementation on malondialdehyde, total antioxidant capacity and paraxonase 1 in polycystic ovary syndrome patients and the practical purpose of the study was to help to prevent and treatment of PCOS and the complications of this disease such as diabetes and cardiovascular disease. Inclusion criteria were woman with polycystic ovary syndrome who had 20-35 years old and Body Mass Index=25-40; Exclusion criteria were Thyroid disorders; hyperprolactinemia; cushing syndrome; liver, kidney and cardiovascular disease; diabetes; pregnancy and lactation; smoking; use of anti obesity drugs; lipid lowering agent; glucocorticids; anti coagulation drugs; use a lowering weight diet; have a usual sports program; receiving omega-3 supplement during 2 month ago and receiving any nutritional supplements during the study. A general questionnaire (including age, weight, height, Body Mass Index,...) and 3 days food record completed for each subjects at the beginning of the study. Then the subjects were randomly assigned to intervention and control group. Fasting venous blood sample obtained from each patients at the beginning of the study and biochemical parameters like malondialdehyde, total antioxidant capacity and paraoxonase1 measured. Patients in intervention group took 2 omega-3 capsules with 1gr weight (containing 360 mg EPA and 240 mg DHA) for 2 month and control group took 2 capsules containing sunflower oil for 2 month. The participants advised to keep their diet and physical activity with no changes. At the end of the study the anthropometric measurements and food intake evaluated again and blood sampling obtained again for measuring biochemical parameters.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106243664N5
Registration date:2011-07-18, 1390/04/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-07-18, 1390/04/27
Registrant information
Name
Maryam Rafraf
Name of organization / entity
Tabriz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
rafrafm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research, Tabriz University of Medical Science
Expected recruitment start date
2010-11-22, 1389/09/01
Expected recruitment end date
2011-01-21, 1389/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of omega-3 fatty acids supplementation on serum levels of malondialdehyde, total antioxidant capacity and paraoxonase1 in polycystic ovary syndrome patients
Public title
Effect of omega-3 fatty acids supplementation on serum levels of malondialdehyde, total antioxidant capacity and paraoxonase1 in polycystic ovary syndrome patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:woman with polycystic ovary syndrome; 20-35 years old and BMI=25-40; Exclusion criteria: Thyroid disorders; hyperprolactinemia; cushing syndrome; liver,kidney and cardiovascular disease; diabetes; pregnancy and lactation; smoking; use of anti obesity drugs; lipid lowering agent; glucocorticids; anti coagulation drugs; use a lowering weight diet; have a usual sports program; receiving omega-3 supplement during 2 month ago and receiving any nutritional supplements during the study.
Age
From 20 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Science
Street address
Tabriz University of Medical Science, Attar Neishabouri Avenue, Golgasht street, Tabriz
City
Tabriz
Postal code
Approval date
2010-12-13, 1389/09/22
Ethics committee reference number
5/4/7663
Health conditions studied
1
Description of health condition studied
polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Malondialdehyde(MDA)
Timepoint
baseline and at the end of intervention
Method of measurement
Fluorimetry method
Secondary outcomes
1
Description
Total antioxidant capacity
Timepoint
baseline and at the end of intervention
Method of measurement
FRAP
2
Description
paraxonase1(PON1)
Timepoint
baseline and at the end of intervention
Method of measurement
Spectrophotometry
Intervention groups
1
Description
Intervention group: 2 capsules of omega-3 containing 360 mg EPA and 240 mg DHA for 2 months
Category
Other
2
Description
Control group: 2 placebo capsules containing sunflower oil for 2 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra clinic
Full name of responsible person
Elahe Mohammadi
Street address
Health and nutrition school, Attar Neishabouri Avenue, Golgasht street, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nutritional Research Center,Tabriz University of Medical Sciences
Full name of responsible person
Dr Alireza Ostadrahimi
Street address
Health and nutrition school, Attar Neishabouri Avenue, Golgasht street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nutritional Research Center,Tabriz 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
Tabriz University of Medical science
Full name of responsible person
Elahe Mohammadi
Position
MS student in Nutrition
Other areas of specialty/work
Street address
Health and Nutrition School, Attar Neishabouri Avenue, Golgasht street,Tabriz
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
e.mohamadi52@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical science
Full name of responsible person
Elahe Mohammadi
Position
MS student in Nutrition
Other areas of specialty/work
Street address
Health and Nutrition School, Attar Neishabouri Avenue, Golgasht street,Tabriz
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
e.mohamadi52@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Science
Full name of responsible person
Elahe Mohammadi
Position
MS student in Nutrition
Other areas of specialty/work
Street address
Health and Nutrition School, Attar Neishabouri Avenue, Golgasht street,Tabriz
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
e.mohamadi52@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)