Comparison of the effects of Camelina and Sunflower oils on metabolic, inflammatory and anti-inflammatory factors in patients with Non-alcoholic fatty liver
Comparison of the effects of Camelina and Sunflower oils on metabolic, inflammatory and anti-inflammatory factors in patients with Non-alcoholic fatty liver
Design
In this study, the target population will be those with NAFLD, who were included by a gastroenterologist with ultrasound examination based on inclusion criteria. After obtaining written consent the target population will be divided into camelina and Or the sunflower oil groups randomly. 15% of the total 30% of dietary fat should be allocated to mentioned oils.
Settings and conduct
This three-blind study is carried out at the Faculty of Nutrition, Tabriz University of Medical Sciences
Participants/Inclusion and exclusion criteria
Patients with NAFLD and lack of inclusion criteria (having other liver disease apart from NAFLD, liver transplant, pregnancy and lactation)
Intervention groups
Intervention (recipient of weight reduction diet + camelina oil) control (recipient of weight reduction diet + sunflower oil)
Main outcome variables
En Alanine amino transferase (ALT); aspartate amino transferase (AST); alkaline phosphatase (ALP); Degree of hepatic steatosis; fasting blood glucose; fasting insulin; insulin resistance; insulin sensitivity; total cholesterol (TC); low triglyceride High density lipoprotein (HDL); tumor necrosis factor-alpha (TNF-α); high-sensitivity c-reactive protein (Hs-CRP); interleukin-10 (IL-10)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150205020965N5
Registration date:2019-12-13, 1398/09/22
Registration timing:registered_while_recruiting
Last update:2019-12-13, 1398/09/22
Update count:1
Registration date
2019-12-13, 1398/09/22
Registrant information
Name
Parvin Dehghan
Name of organization / entity
Tabriz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 7580
Email address
dehghanp@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-20, 1398/08/29
Expected recruitment end date
2020-05-18, 1399/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of Camelina and Sunflower oils on metabolic, inflammatory and anti-inflammatory factors in patients with Non-alcoholic fatty liver
Public title
The effect of camelina oil in patients with nonalcoholic fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 20 to 65 years
BMI≥25
No weight changes over the past 3 months
Restricted Consumption of edible nuts and fish
Tendency to use camelina oil
Having grade 1 and 2 of non-alcoholic fatty liver disease
Exclusion criteria:
Having other liver disease apart from NAFLD (alcoholic fatty liver, viral hepatitis, cirrhosis and biliary obstruction, liver cancer))
Liver transplantation
Pregnancy and Lactation
Kidney, Cardiovascular Disease
Alcohol and tobacco consumption
high physical activity
having acute illness
Use of drugs such as glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDS), hepatotoxic drugs, antibiotics
Use antioxidant supplements and W3
history of using weight loss diet or a special diet over the past 6 months
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Classification of these variables will be used to match them in BMI, age and sex. All of the 23 patients will be randomly divided into two groups including intervention (Weight loss diet+ Camelina oil ) and control (Weight loss diet + Sunflower oil) by using RAS software which is dividing patients to 2 and 4 blocks, 1 and 2 codes will be given them respectively too.
Blinding (investigator's opinion)
Triple blinded
Blinding description
After randomizing, the same weight loss diets with similar recommendations will be given by a dietitian to both groups.Both oils will be packaged in similar 900 grams opaque containers, without the researcher intervention and will be coding (1 and 2). The dietitian will introduce the oils by codes to patients.Until the reporting the results patient, researcher and analyser will not be aware of the codes. After the end of research, decodation will be done. So the study will be Triple-Blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی تبریز
Street address
تبریز، خیابان گلگشت، دانشگاه علوم پزشکی تبریز، ساختمان مرکزی شماره2
In this study, Camelina oil will be replaced with 15% of the daily total fat intake for three months. Then, 15 days before the beginning of study, FFQ questionnaire will be completed for selected patients based on inclusion and exclusion criteria to determine the dietary pattern of patients. Patients will also be asked not to use omega-3 oils (as mentioned in list), during this time. Then, basal energy expenditure of each person will be calculated by Mifflin equation based on their weight, age, sex and total energy expenditure will be calculated according to the person's daily physical activity. For losing weight, 500 kcal reduction of total energy expenditure will be done, and then macronutrients will be distributed to 50% carbohydrate, 30% fat, 20% protein, and the proper diet will be adjusted according to one's dietary pattern. 15% of the dietary fat will be provide by Camelina oil (prepared by cold press, rich in omega-3 fatty acids, then will be analyzed before intervention). Patients will be instructed to measure the recommended amount of oil with the modules given with the oil, and add it to their salad or meal every day (while consuming or cooking), and intake the remain amount from dairy fat, meat and other oils. The oils will be given monthly to patients, and they will be advised to keep the consuming oil inside the refrigerator, depending on the type of processing (cold press). Each week a phone call will be made to ensure adherence to the diet, oil intake, and patient status assessment will be done. Patients will be asked to deliver the remaining oil bottles each month to receive the new oil bottles for the following month to ensure consumption and following them up. Patients will be advised to avoid fried foods, simple carbohydrates, solid oils and will be advised to use steamed foods as much as possible. Patients will be asked to report any gastrointestinal problems or not possibility of oil intake to available numbers. Metabolic, biochemical, anthropometric parameters, blood pressure and dietary intakes will be assessed before and after intervention.
Category
Treatment - Drugs
2
Description
In this study, Sunflower oil will be replaced with 15% of the daily total fat intake for three months. Then, 15 days before the beginning of study, FFQ questionnaire will be completed for selected patients based on inclusion and exclusion criteria to determine the dietary pattern of patients. Patients will also be asked not to use omega-3 oils (as mentioned in list), during this time. Then, basal energy expenditure of each person will be calculated by Mifflin equation based on their weight, age, sex and total energy expenditure will be calculated according to the person's daily physical activity. For losing weight, 500 kcal reduction of total energy expenditure will be done, and then macronutrients will be distributed to 50% carbohydrate, 30% fat, 20% protein, and the proper diet will be adjusted according to one's dietary pattern. 15% of the dietary fat will be provide by Sunflower oil (prepared by cold press, rich in omega-3 fatty acids, then will be analyzed before intervention). Patients will be instructed to measure the recommended amount of oil with the modules given with the oil, and add it to their salad or meal every day (while consuming or cooking), and intake the remain amount from dairy fat, meat and other oils. The oils will be given monthly to patients, and they will be advised to keep the consuming oil inside the refrigerator, depending on the type of processing (cold press). Each week a phone call will be made to ensure adherence to the diet, oil intake, and patient status assessment will be done. Patients will be asked to deliver the remaining oil bottles each month to receive the new oil bottles for the following month to ensure consumption and following them up. Patients will be advised to avoid fried foods, simple carbohydrates, solid oils and will be advised to use steamed foods as much as possible. Patients will be asked to report any gastrointestinal problems or not possibility of oil intake to available numbers. Metabolic, biochemical, anthropometric parameters, blood pressure and dietary intakes will be assessed before and after intervention.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان بین المللی تبریز
Full name of responsible person
دکتر منوچهر خوش باطن
Street address
بیمارستان بین الملل تبریز، اول زعفرانیه، میدان افلاک نما
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3332 8832
Email
mkhoshbaten@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
استاد علیرضا رحیمی
Street address
تبریز، خیابان گلگشت، دانشگاه علوم پزشکی تبریز، دانشکده تغذیه و علوم غذایی
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7581
Email
ostadrahimi@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Parvin Dehghan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 33340634
Email
dehghan.nut@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parvin dehghan
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 914 471 0299
Email
Dehghan.nut@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parvin dehghan
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 914 471 0299
Email
Dehghan.nut@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Title and more details about the data/document
Reporting the results
When the data will become available and for how long
After finishing and publishing the project articles
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
With the permission of the project researcher and the project sponsoring organization - University of Nutrition Research and Research Deputy
From where data/document is obtainable
Dr. Parvin Dehghan, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences Email:Dehghan.nut@gmail.com +98 914 471 0299
What processes are involved for a request to access data/document
The applicator can send a request to the person responsible for the study by email.