Effect of flaxseed oil supplementation on severity of depression and serum level of BDNF- α in depressed women: a randomized, double blind clinical trial
1-Comparison of Depression Severity Changes in Depressed Women Before and After Intervention (flaxseed oil Supplementation) in Treatment and Control group.
2-Comparison of serum level of BDNF changes in Depressed Women Before and After Intervention (flaxseed oil Supplementation) in Treatment and Control group.
Design
This study is a double blind randomized clinical trial in which 60 depressed women will be enrolled to study according to DSM-IV criteria. Then, participants will be divided equally into intervention and control groups using permuted block randomization
Settings and conduct
60 women referred to Imam Khomeini clinic will be randomly divided to intervention and control groups. The intervention group will receive flaxseed oil supplementation for 10 weeks, 1000 mg, 2 time per day and the control group will receive placebo. At the beginning and end of the study 3 ml of venous blood (for assessment of BDNF) is taken from all patients and Beck's questionnaire will be completed to assess the severity of depression
Participants/Inclusion and exclusion criteria
1-Ages 18 to 45 years old
2-having depression confirmed by a Psychiatrist according to DSM-IV criteria and being treated with antidepressant medications
3-Willingness to cooperate in the project
exclusion criteria:
1-having cardiovascular disease and hypertension
2-having kidney, liver, cancer, diabetes and inflammatory diseases
3-having addiction and taking any drugs, tobacco or alcohol
4-taking any multivitamin and omega-3 supplements 3 months before the study
5-having cysts in the breast and ovary or having family history of cysts
Intervention groups
intervention group: participants will receive flaxseed oil supplementation 100 milligram, twice daily
control group: participants will receive placebo contained paraffin twice daily
Main outcome variables
1-depression severity
2- serum level of BDNF
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130903014551N3
Registration date:2019-10-07, 1398/07/15
Registration timing:prospective
Last update:2019-10-07, 1398/07/15
Update count:0
Registration date
2019-10-07, 1398/07/15
Registrant information
Name
Mohammad Hossein Rouhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3183
Email address
s_m_rouhani2003@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-14, 1398/07/22
Expected recruitment end date
2020-01-22, 1398/11/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of flaxseed oil supplementation on severity of depression and serum level of BDNF- α in depressed women: a randomized, double blind clinical trial
Public title
Effect of flaxseed oil supplementation on severity of depression and serum level of BDNF- α in depressed women: a randomized, double blind clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages 18 to 45 years old
Having Depression confirmed by a Psychiatrist according to DSM-IV criteria and being treated with antidepressant medications
Willingness to cooperate in the project
Exclusion criteria:
Having cardiovascular disease and hypertension
Having kidney, liver, cancer, diabetes and inflammatory diseases
Having addiction and taking any drugs, tobacco or alcohol
Taking any multivitamin and omega-3 supplements 3 months before the study
Having cysts in the breast and ovary or having family history of cysts
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done through block randomization method (permuted blocked randomization). depending on the sample size , each block includes 4 characters and will be used AABB combination. In the following, all possible modes from the combination will be listed and a code will be allocated to each patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
For double blinding of this study, at the beginning, cans contained flaxseed supplement and placebo were coded as A and B by person other than researcher to ensure researcher and participants were not informed about types of supplement received by participants
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
Esfahan University of Medical Sciences, Hezar Jerib street, Esfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-05-28, 1398/03/07
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.134
Health conditions studied
1
Description of health condition studied
Depressive disorder
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
Primary outcomes
1
Description
Severity of depression
Timepoint
Before and after intervention
Method of measurement
Beck questionnaire
2
Description
Serum level of BDNF
Timepoint
Before and after intervention
Method of measurement
ELISA method
Secondary outcomes
1
Description
Physical activity
Timepoint
At the beginning and end of the intervention
Method of measurement
Physical activity record questionnaire
2
Description
Dietary intake
Timepoint
At the beginning the intervention, In the fifth week and end of the intervention
Method of measurement
Two day food record
Intervention groups
1
Description
Intervention group: Patients in this group will receive flaxseed oil supplementation, 1000 mg, made by Barijessence company twice a day for 10 weeks.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group will receive a paraffin-containing placebo made by Barijessence company, 2 times daily for 10 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Clinic
Full name of responsible person
Dr.Maryam Poorbafrani
Street address
Imam Khomeini clinic, Imam avenue, Naein
City
Naein
Province
Isfehan
Postal code
83918111111
Phone
+98 31 4626 5348
Email
mpoorbafrani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoo Javanmard
Street address
Deputy of Research & Technology of Esfahan University of Medical Sciences, Hezar Jarib Street, Esfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Fax
+98 31 3668 7898
Email
sh_haghjoo@med.mui.ac.ir
Web page address
http://research.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Seyyed Morteza Safavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Esfahan University of Medical Sciences, Hezar Jarib Street, Esfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3168
Email
safavimorteza@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Seyyed Morteza Safavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Esfahan University of Medical Sciences, Hezar Jarib Street, Esfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3168
Email
safavimorteza@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Seyyed Morteza Safavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Esfahan University of Medical Sciences, Hezar Jarib street, Esfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3168
Email
safavimorteza@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available