Compare the effect of flaxseed and sunflower oil on anthropometric characteristics, pressure and blood lipids and liver enzymes in patients with nonalcoholic fatty liver in overweight patients with a low-calorie diet
The aim of study is the effects of flaxseed and sunflower oils on anthropometric characteristics, blood pressure, blood lipids and liver enzymes in overweight patients with nonalcoholic fatty liver in a low-calorie diet. The study is Clinical trial, double-blind, and is performed on 80 patients with non-alcoholic fatty liver randomly divided into two intervention and control group of 40 people. Inclusion criteria: Nonalcoholic fatty liver diseas ;BMI = 25 and above ; lack of type 2 diabetes ; hepatic and cardiovascular disease ;avoiding the use of lipid lowering agents and exclusion criteria: avoid taking diet for more than 15 days in 3 months. Each of the interventional and control groups receive 20 g of flaxseed oil and sunflower oil daily for three months. Diet is calculated separately for each one. 3-day recalls, blood pressure, anthropometric measurements will be taken at the beginning and end of study and end of each month. Blood samples were collected at the beginning and end of the study. The primary outcomes include: changes in body mass index, blood pressure, liver enzymes, lipid profiles, changes in liver fat accumulation and the degree of fatty liver.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016011125957N1
Registration date:2016-02-07, 1394/11/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-07, 1394/11/18
Registrant information
Name
Shahla Rezaei
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3825 7036
Email address
shahlarezaei13932014@gmail.com
Recruitment status
Recruitment complete
Funding source
Oil Version Factory-School of Nutrition and Food Sciences, Shiraz
Expected recruitment start date
2015-12-16, 1394/09/25
Expected recruitment end date
2017-02-13, 1395/11/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effect of flaxseed and sunflower oil on anthropometric characteristics, pressure and blood lipids and liver enzymes in patients with nonalcoholic fatty liver in overweight patients with a low-calorie diet
Public title
The effect of flaxseed oil in the treatment of non-alcoholic fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having NAFLD by medical diagnosis (using ultrasound) ; BMI = 25 and above ; willingness to participate in the study, the absence of diabetes mellitus type 2 ;heart disease ;cardiovascular and liver disease (cirrhosis, liver disease Alcohol, viral hepatitis, autoimmune hepatitis, primary biliary cirrhosis, biliary obstruction, liver damage induced by drugs hereditary Hemochromatosis, sclerosis cholangitis and antitrypsin deficiency of α-a-1) ;other serious diseases such as cancer ;kidney failure and celiac disease, etc) ;lack of pregnancy ;lactation ;lack of drugs that are causing fatty liver (methotrexate, tamoxifen, Valproate, etc.) ;avoiding the use of any type of lipid lowering agents (atorvastatin, lovastatin, pravastatin, etc.) ;fibrates (gemfibrozil, fenofibrate) ;lack of malnutrition ;have no special diets such as vegan and vegetarian ;not drinking alcohol and having over 18 years of age. Exclusion criteria: non-compliance with recommended diet for more than 15 days over 3 months ;acute or infectious disease ;hospitalization or in cases where the criteria mentioned is.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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, School of Nutrition
Street address
Shiraz, Razi Blvd.
City
Shiraz
Postal code
Approval date
2015-12-13, 1394/09/22
Ethics committee reference number
IR.Sums.REC.1394.150
Health conditions studied
1
Description of health condition studied
Nonalcoholic Fatty Liver
ICD-10 code
K76.0
ICD-10 code description
(Nonalcoholic fatty liver disease (NAFLD
Primary outcomes
1
Description
blood pressure
Timepoint
Before the intervention, after the intervention and the end of each month
Method of measurement
Barometer
2
Description
Lipid profile
Timepoint
Before the intervention, after intervention
Method of measurement
blood test
3
Description
Anthropometric indices
Timepoint
Before the intervention, after the intervention and the end of each month
Method of measurement
Devices BIA, scales, meters
4
Description
Liver enzymes
Timepoint
Before the intervention, after intervention
Method of measurement
blood test
5
Description
Changing in the degree of fatty liver
Timepoint
Before the intervention, after the intervention
Method of measurement
Ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
The control group consisted of 40 patients. Randomly placed in this group. 20 grams per day for 3 months receive sunflower oil. Diet and recommendations are presented separately for each person. The exact consumption of oil is measured by graded modules. Outcomes measured before and after the intervention. At the beginning and end of study and end of each month, 3-day recall, blood pressure and anthropometric indices will be taken.
Category
Treatment - Drugs
2
Description
The intervention group consisted of 40 patients. Randomly placed in this group. 20 grams per day for 3 months receive flaxseed oil. Diet and recommendations are presented separately for each person. The exact consumption of oil is measured by graded modules. Outcomes measured before and after the intervention. At the beginning and end of study and end of each month, 3-day recall, blood pressure and anthropometric indices will be taken.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Martyr Motahari clinic
Full name of responsible person
Shahla Rezaei
Street address
Shiraz, Namazi Square
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oil Version Factory
Full name of responsible person
Sales Office
Street address
Gorgan
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oil Version Factory
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
Department of Food Science and Nutrition
Full name of responsible person
Doctor Masume Akhlaghi
Position
Assistant Professor
Other areas of specialty/work
Street address
Shiraz, Iran, Razi School of Nutrition and Food Science
City
Shiraz
Postal code
Phone
+98 71372510018
Fax
Email
shahlarezaei13932014@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Nutrition and Food Science
Full name of responsible person
Doctor Masume Akhlaghi
Position
Assistant Professor
Other areas of specialty/work
Street address
Shiraz, Razi Blvd.
City
Shiraz
Postal code
Phone
+7 1372510018
Fax
Email
shahlarezaei13932014@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Shahla Rezaei
Position
Master student of nutrition
Other areas of specialty/work
Street address
Razi Blvd
City
Shiraz
Postal code
7167693515
Phone
+98 983 725 1005
Fax
Email
shahlarezaei13932014@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)