Evaluating the effects of replacing ghee with rapeseed oil on liver steatosis and enzymes, lipid profile, insulin resistance, and anthropometric measurements in patients with non-alcoholic fatty liver disease
Determining the effects of replacing ghee with rapeseed oil on liver steatosis and enzymes, lipid profile, insulin resistance, and anthropometric measurements in patients with non-alcoholic fatty liver disease
Design
Parallel randomized controlled trial
Settings and conduct
The present study aiming to evaluate The effects of replacing ghee with rapeseed oil on liver steatosis and enzymes, lipid profile, insulin resistance, and anthropometric measurements in patients with non-alcoholic fatty liver disease.This study will be conducted in imam khomeini teaching hospital in urmia. This study is a parallel randomized controlled trial. 110 Patients will be randomly allocated into two groups, including intervention group and the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with non-alcoholic fatty liver disease more than 18 years from both sexes
Patients with non-alcoholic fatty liver disease with a BMI less than 30
Patients with non-alcoholic fatty liver disease with daily ghee consumption of 3 to 8servings per day
Exclusion criteria: special diets
Pregnancy and lactation during the study
Viral hepatitis
Alcohol consumption or history of alcohol consumption
Diabetes mellitus
Psychotic disorders
Non-compliance to our recommendations regarding fat consumption
Untreated hypothyroidism
Renal Diseases
Taking medications which increase GGT levels
Heart failure and bone disease
Alpha antitrypsin deficiency
Gastrointestinal diseases such as celiac disease
smoking
Menopause
Herbal therapy
Intervention groups
In the intervention group, in addition to the usual treatment, it will be recommended to change their fat intake to rapeseed oil. The control group will be advised to continue usual fat consumption.
Evaluating the effects of replacing ghee with rapeseed oil on liver steatosis and enzymes, lipid profile, insulin resistance, and anthropometric measurements in patients with non-alcoholic fatty liver disease
Public title
Effect of the type of oil on treatment of non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with non-alcoholic fatty liver disease more than18 years from both sexes
Patients with non-alcoholic fatty liver disease with a BMI less than 30
Patients with non-alcoholic fatty liver disease with daily ghee consumption of 3 to 8 servings
Exclusion criteria:
special diets
Pregnancy and lactation during the study
Viral hepatitis
Alcohol consumption or history of alcohol consumption
Diabetes mellitus
Psychotic disorders
Non-compliance to our recommendations regarding fat consumption
Untreated hypothyroidism
Renal Diseases
Taking medications which increase GGT levels
Heart failure and bone disease
Alpha antitrypsin deficiency
Gastrointestinal diseases such as celiac disease
smoking
Menopause
herbal therapy
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with Non-Alcoholic Fatty liver disease referred to the gastroenterology clinic of Urmia Imam Khomeini Teaching Hospital will be selected consecutively on the basis of inclusion and exclusion criteria during the three months. The method will be used for randomization is the block randomization method to ensure that exactly the same number of participants will be randomly allocated to the intervention and control groups. In this method, one type of treatment is given to the first block and another type to the second block. The number of blocks will be two blocks due to two treatments.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Urmia University of Medical Sciences
Street address
Orjhans Street, Resalat Blvd, Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2021-11-10, 1400/08/19
Ethics committee reference number
IR.UMSU.REC.1400.355
Health conditions studied
1
Description of health condition studied
Non alcoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Weight
Timepoint
At weeks 0, 12
Method of measurement
Scale. kg
2
Description
Body mass index
Timepoint
At weeks 0, 12
Method of measurement
Weight(kg)/[height(m)]2 , kg/m2
3
Description
Gamma Glutamyl transferase
Timepoint
At weeks 0,12
Method of measurement
Enzymatic method , IU/ Lit
4
Description
ALP
Timepoint
At weeks 0, 12
Method of measurement
Enzymatic method , IU/ Lit
5
Description
Aspartat transaminase
Timepoint
At weeks 0, 12
Method of measurement
Enzymatic method, IU/Lit
6
Description
Alanine Aminotransferase
Timepoint
At weeks 0, 12
Method of measurement
Enzymatic method, IU/ Lit
7
Description
Fasting blood sugar
Timepoint
At weeks 0, 12
Method of measurement
Enzymatic method, IU/ Lit
8
Description
Serum insulin
Timepoint
At weeks 0, 12
Method of measurement
Radioimmunoassay
9
Description
Waist circumference
Timepoint
At weeks 0, 12
Method of measurement
Cm
10
Description
Hepatic steatosis
Timepoint
Before intervention and three month after intervention
Method of measurement
Ultrasonography
11
Description
HDL cholesterol
Timepoint
At weeks 0, 12
Method of measurement
Enzymatic method, mg/dl
12
Description
Triglyceride
Timepoint
At weeks 0, 12
Method of measurement
Enzymatic method, mg/dl
13
Description
LDL cholesterol
Timepoint
At weeks 0, 12
Method of measurement
Enzymatic method, mg/dl
14
Description
Total cholesterol
Timepoint
At weeks 0, 12
Method of measurement
Enzymatic method, mg/dl
15
Description
HOMA-IR
Timepoint
At weeks 0, 12
Method of measurement
Formula
16
Description
Height
Timepoint
Before intervention
Method of measurement
Before intervention
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group, in addition to the usual treatment, will be recommended to change their fat intake to rapeseed oil.
Category
Treatment - Other
2
Description
Control group: At first, people with daily consumption of 3 -8 servings or 15- 40 gr of ghee in cooking or flavoring will be selected. The control group, in addition to the usual treatment, will be advised to continue their usual fat consumption.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Teaching Hospital, Urmia
Full name of responsible person
Dr. Mohammad Reza mohammad hosseini azar
Street address
Ershad Blvd, Ayatollah Modarres Blvd, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5431234567
Phone
+98 44 3567 8549
Email
hosseiniazar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr Saber gholizadeh
Street address
Orjhans Street, Resalat Blvd, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 21 8753 2210
Email
saber@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Mohammad Alizadeh
Position
Professor in Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, School of Medicine, Urmia University of Medical Science, 11th km of Nazloo Highway, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5715799313
Phone
+98 44 3275 2375
Email
alizadeh.m@umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Mohammad Alizadeh
Position
Ph.D in Nutrition/ Professor in Urmia University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, School of Medicine, Urmia University of Medical Science, 11th km of Nazloo Highway, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5315799313
Phone
+98 44 3275 2375
Email
alizadeh.m@umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Fatemeh Maleki Sedgi
Position
MSc Student of nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, School of Medicine, Urmia University of Medical Science, 11th km of Nazloo Highway, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5715799313
Phone
+98 44 3275 2375
Email
F.maleki1998@gmail.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