Evaluating the effect of replacing clarified butter with canola oil on Metabolic Syndrome components, fatty liver index, and insulin resistance in patients with Metabolic Syndrome
Determining the effects of replacing clarified butter with canola oil on Metabolic Syndrome components, fatty liver index, and insulin resistance in patients with Metabolic Syndrome
Design
Before and After clinical trial, one intervention group, 42 patients
Settings and conduct
The present study is the effect of canola oil in the treatment of metabolic syndrome, conducted at the liver and gastrointestinal clinic of Imam Khomeini hospital in Urmia city. The study involved replacing the clarified butter consumed by individuals with canola oil, and providing in-person and telephone counseling and educational materials on healthy nutrition and physical activity.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having metabolic syndrome according to International Diabetes Federation (IDF) guideline
Age range from 35 to 65 years
Daily clarified butter consumption of 3 to 8 servings
Exclusion criteria: Renal disease
Heart failure
Having various type of cancer
Psychotic disorders
Pregnancy and lactation during the study
Intervention groups
Individuals will be selected who consume ghee or clarified butter for cooking, with a daily consumption of 3 to 8 units of this oil. In addition to the usual treatment, All individuals will be advised to replace clarified butter with the same amount of canola oil.To ensure compliance with recommendations and to examine food groups and physical activity during the study, a 24-hour recall questionnaire will be completed for three days (two non-holiday days and one holiday) and a physical activity questionnaire before the start of the study and at the end of each month during the study. Also, patients will be contacted by phone every week and necessary reminders will be given.
Main outcome variables
Metabolic Syndrome components; Insulin resistance; Fatty Liver Index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170206032417N6
Registration date:2023-06-18, 1402/03/28
Registration timing:prospective
Last update:2023-06-18, 1402/03/28
Update count:0
Registration date
2023-06-18, 1402/03/28
Registrant information
Name
Mohammad Alizadeh
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 2375
Email address
alizadeh.m@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-06, 1402/04/15
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of replacing clarified butter with canola oil on Metabolic Syndrome components, fatty liver index, and insulin resistance in patients with Metabolic Syndrome
Public title
Effect of type oil in treatment of Metabolic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having metabolic syndrome according to International Diabetes Federation (IDF) guideline
Age range from 35 to 65 years
Daily clarified butter/ghee consumption of 3 to 8 servings
Exclusion criteria:
Renal disease
Heart failure
Having various type of cancer
Psychotic disorders
Pregnancy and lactation during the study
Age
From 35 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of 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
2023-01-15, 1401/10/25
Ethics committee reference number
IR.UMSU.REC.1401.359
Health conditions studied
1
Description of health condition studied
Metabolic syndrome
ICD-10 code
E88.81
ICD-10 code description
سندرم متابولیک
Primary outcomes
1
Description
Fasting blood sugar
Timepoint
Measurement of fasting blood sugar at the beginning of the study (before the intervention) and 12 weeks (after the intervention) after the start of canola oil consumption.
Method of measurement
Enzymatic method, IU/ Lit
2
Description
Waist circumference
Timepoint
Measurement of waist circumference at the beginning of the study (before the intervention) and 12 weeks (after the intervention) after the start of canola oil consumption.
Method of measurement
Meter, Cm
3
Description
HDL cholesterol
Timepoint
Measurement of HDL cholesterol at the beginning of the study (before the intervention) and 12 weeks (after the intervention) after the start of canola oil consumption.
Method of measurement
Enzymatic method, mg/dl
4
Description
Triglyceride
Timepoint
Measurement of Triglyceride at the beginning of the study (before the intervention) and 12 weeks (after the intervention) after the start of canola oil consumption.
Method of measurement
Enzymatic method, mg/dl
5
Description
Systolic blood pressure
Timepoint
Measurement of Systolic blood pressure at the beginning of the study (before the intervention) and 12 weeks (after the intervention) after the start of canola oil consumption.
Method of measurement
Sphygmomanometer, mm Hg
6
Description
Diastolic blood pressure
Timepoint
Measurement of Diastolic blood pressure at the beginning of the study (before the intervention) and 12 weeks (after the intervention) after the start of canola oil consumption.
Method of measurement
Sphygmomanometer, mm Hg
Secondary outcomes
1
Description
Weight
Timepoint
Measurement of weight at the beginning of the study (before the intervention) and 12 weeks (after the intervention) after the start of canola oil consumption.
Method of measurement
Scale. kg
2
Description
Body mass index
Timepoint
Measurement of BMI at the beginning of the study (before the intervention) and 12 weeks (after the intervention) after the start of canola oil consumption.
Method of measurement
Weight(kg)/[height(m)]2 , kg/m2
3
Description
Gamma Glutamyl transferase
Timepoint
Measurement of GGT at the beginning of the study (before the intervention) and 12 weeks (after the intervention) after the start of canola oil consumption.
Method of measurement
Enzymatic method , IU/ Lit
4
Description
Serum insulin
Timepoint
Measurement of Serum insulin at the beginning of the study (before the intervention) and 12 weeks (after the intervention) after the start of canola oil consumption.
Method of measurement
Radioimmunoassay
5
Description
low-density lipoprotein cholesterol
Timepoint
Measurement of LDL at the beginning of the study (before the intervention) and 12 weeks (after the intervention) after the start of canola oil consumption.
Method of measurement
Enzymatic method, mg/dl
6
Description
Total cholesterol
Timepoint
Measurement of Total cholesterol at the beginning of the study (before the intervention) and 12 weeks (after the intervention) after the start of canola oil consumption.
Method of measurement
Enzymatic method, mg/dl
7
Description
Homeostasis model assessment-insulin resistance
Timepoint
Measurement of HOMA-IR at the beginning of the study (before the intervention) and 12 weeks (after the intervention) after the start of canola oil consumption.
Measurement of Height at the beginning of the study (before the intervention)
Method of measurement
Stadiometer- cm
9
Description
Quantitative insulin sensitivity check index
Timepoint
Measurement of QUICKI at the beginning of the study (before the intervention) and 12 weeks (after the intervention) after the start of canola oil consumption.
Measurement of FLI at the beginning of the study (before the intervention) and 12 weeks (after the intervention) after the start of canola oil consumption.
Initially, individuals will be selected who consume ghee or clarified butter for cooking, with a daily consumption of 3 to 8 units of this oil. In addition to the usual treatment, all individuals will be advised to switch to the same amount of canola oil they used for cooking. To ensure uniform consumption of other food groups in individuals, everyone will be advised to follow the Food and Agriculture Organization (FAO) recommendations for Iranians. All participants will be asked not to change their physical activity and medication during the study. The dosage of medications (vitamin E and pioglitazone) will be the same for all individuals from the beginning to the end of the study. To ensure compliance with recommendations and to examine food groups and physical activity during the study, a 24-hour recall questionnaire will be completed for three days (two non-holiday days and one holiday) and a physical activity questionnaire before the start of the study and at the end of each month during the study, totaling 12 questionnaires for the dietary recall and 4 days for the physical activity questionnaire during the study. Also, patients will be contacted by phone every week and necessary reminders will be given. The counseling program for patients will include one in-person counseling session, provision of educational materials, and relevant text messages. The duration of intervention is 12 weeks.
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