Our study has been designed with the aim of investigating the effects of walnut oil on lipid profiles of hyperlipidemic type 2 diabetic patients. In a double-blind, randomized placebo-controlled study, 90 hyperlipidemic type 2 diabetic patients aged between 18-75 referred to Shiraz Healthy Heart Home have been selected according to the inclusion criteria, including plasma TG level more 150 mg/dL or total cholestrol level more 200 mg/dL or LDL between 130-200 or HDL less 50 in female and less 40 in male, and the use of maximum 2 oral diabetes medications. The exclusion criteria have been a history of chronic or metabolic diseases, and the use of insulin and antihyperlipidemic agents. These patients are assigned to receive 15cc Persian walnut (Juglans regia L.) oil or placebo, per day, for 60 days. In order to obtain the values for lipid profiles, “Total cholesterol, TG, HDL, LDL” all of the participants are measured in 2 episodes (before starting the intervention and at the end of intervention).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014030611375N2
Registration date:2014-04-09, 1393/01/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-09, 1393/01/20
Registrant information
Name
pouya farhadi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1625 4206
Email address
farhadip@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Cardiovascular Research center, Shiraz University of Medical Sciences
Expected recruitment start date
2013-10-10, 1392/07/18
Expected recruitment end date
2014-01-10, 1392/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of walnut oil on lipid profiles in hyperlipidemic type 2 diabetic patients
Public title
Effects of walnut oil on lipid profiles in hyperlipidemic type 2 diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients with diagnosed type2 diabetes for at leat 2 years and also with either plasma TG level more 150 mg/dL or total cholestrol level more 200 mg/dL or LDL between 130-200 or HDL less 50 in female and less 40 in male; Patients who received maximum 2 oral diabetes medications.
Exclusion Criteria: Patients who have a history of chronic or metabolic diseases, or regularly use medication (Fibrate and HMG-COA Reductase inhibitor) or supplements known to affect blood lipids; Patients who have to receive antihyperlipidemic agents for example CAD patients; Patients who were currently received insulin therapy.
Age
From 20 years old to 75 years old
Gender
Both
Phase
N/A
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
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz university of medical sciences Building - 7th floor - Zand Ave.
City
Shiraz
Postal code
Approval date
2013-08-13, 1392/05/22
Ethics committee reference number
CT-P-92-5376
Health conditions studied
1
Description of health condition studied
Hyperlipidemia
ICD-10 code
E78
ICD-10 code description
Disorders of lipoprotein metabolism and other lipidaemias
Primary outcomes
1
Description
Serum Triglyceride
Timepoint
Before and 3 months after intervention
Method of measurement
Biochemical measurements on blood sample (GPA-PAP technique)
2
Description
Low-density lipoprotein (LDL)
Timepoint
Before and 3 months after intervention
Method of measurement
Biochemical measurements on blood sample (GPA-PAP technique)
3
Description
High-density lipoprotein (HDL)
Timepoint
Before and 3 months after intervention
Method of measurement
Biochemical measurements on blood sample (dextran magnesium sulfate)
4
Description
Total cholesterol
Timepoint
Before and 3 months after intervention
Method of measurement
Biochemical measurements on blood sample (GPA-PAP technique)
Secondary outcomes
1
Description
Body Mass Index
Timepoint
Before and 2 months after intervention
Method of measurement
By BMI Formula
2
Description
Systolic Blood Pressure
Timepoint
Before and 3 months after intervention
Method of measurement
Mercury sphygmomanometer
3
Description
Diastol Blood Pressure
Timepoint
Before and 3 months after intervention
Method of measurement
Mercury sphygmomanometer
Intervention groups
1
Description
Intervention group will be administered with15cc Persian walnut (Juglans regia L.) oil, per day, for 90 days.
Category
Treatment - Drugs
2
Description
Control group will be received placebo (distilled water capsule) per day, for 90 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Cardiovascular Research Center of Shiraz University of Medical Sciences
Full name of responsible person
Dr. Abbas Mosleh
Street address
Cardiovascular Research Center, Shahid Faghihi Hospital, Zand Blvd
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Midical Sciences
Full name of responsible person
Mrs Hoghooghi
Street address
Cardiovascular Research center,Shahid Faghihi Hospital,Zand Blvd
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Midical 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr.pouya Farhadi
Position
General Physician
Other areas of specialty/work
Street address
Cardiovascular Research Center, Shahid Faghihi Hospital, Zand ave.
City
Shiraz
Postal code
Phone
+98 71 1234 3529
Fax
Email
farhadip@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Cardiovascular Research Center of Shiraz
Full name of responsible person
Dr. Mohammad Javad Zibaeenejhad
Position
Fellowship of Interventional Cardiology
Other areas of specialty/work
Street address
Cardiovascular Research Center, Shahid Faghihi Hospital, Zand ave.
City
Shiraz
Postal code
Phone
+98 71 1234 3529
Fax
Email
zibaeem2@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Pouya Farhadi
Position
General Physician
Other areas of specialty/work
Street address
Cardiovascular Research Center, Shiraz University of Medical Sciences, Zand ave.
City
Shiraz
Postal code
Phone
+98 71 1234 3529
Fax
Email
farhadip@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)