Evaluating the effect of black garlic on liver steatosis and enzymes, lipid profile, insulin resistance, and anthropometric measurements in patients with non-alcoholic fatty liver disease
Determining the effect of black garlic 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 effect of black garlic on liver steatosis and enzymes, lipid profile, insulin resistance, and anthropometric measurements in patients with non-alcoholic fatty liver disease. This study will take place in Imam Khomeini Hospital in Urmia and it is a parallel randomized controlled clinical trial. 110 patients will be randomly assigned to 2 groups.
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 diagnosed through ultrasound and referred to Imam Hospital Gastroenterology Clinic.
Exclusion criteria: Special diets; pregnancy or lactation during the study; viral hepatitis; alcohol consumption or history of alcohol consumption; non-compliance to our recommendations regarding Black garlic consumption; untreated hypothyroidism; renal diseases; taking drugs that increase liver enzymes; alpha antitrypsin deficiency; gastrointestinal disease such as celiac disease; menopause; diabetes mellitus; herbal therapy; heart failure and bone disease.
Intervention groups
In the intervention group, in addition to the usual treatment, will be recommended to consume 6 grams of black garlic in total per day before morning and evening meal. In addition to the usual fatty liver treatment, the control group was advised to follow FAO (Food and Agriculture Organization) recommendations by the researcher.
Evaluating the effect of black garlic on liver steatosis and enzymes, lipid profile, insulin resistance, and anthropometric measurements in patients with non-alcoholic fatty liver disease
Public title
Effect of Black garlic consumption on treatment of non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age older than 18 years old from both sexes
BMI more than 30
Patients with non-alcoholic fatty liver disease diagnosed through ultrasound and referred to Imam Hospital Gastroenterology Clinic
Exclusion criteria:
Special diets
Pregnancy and lactation during the study
Viral hepatitis
Alcohol consumption or history of alcohol consumption
Non-compliance to our recommendations regarding Black garlic consumption
Untreated hypothyroidism
Renal diseases
Taking drugs that increase liver enzymes
Alpha antitrypsin deficiency
Gastrointestinal disease such as celiac disease
Menopause
Diabetes mellitus
Herbal therapy
Heart failure and bone disease
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
The method used for randomization is Stratified Randomization. In this method, to eliminate the heterogeneity in age, gender and severity of steatosis variables, before applying random allocation, the samples will be classified based on these variables and then they will be randomly allocated into intervention and control groups.
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
Research Ethics Committee of Urmia University of Medical Sciences - Imam Khomeini University Hospita
Street address
Imam Khomeini Hospital; Ershad Blvd., Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5715789397
Approval date
2022-08-30, 1401/06/08
Ethics committee reference number
IR.UMSU.HIMAM.REC.1401.041
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
Alkalin Phosphatase
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
Stadiometer, mm
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, in addition to the usual treatment, will be recommended to consume 6 grams of black garlic in total per day before morning and evening meal for three months.
Category
Treatment - Other
2
Description
Control group: In addition to the usual fatty liver treatment, the control group was advised to follow FAO (Food and Agriculture Organization) recommendations by the researcher for three months.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Teaching Hospital, Urmia
Full name of responsible person
Mohammad Reza Pashaei
Street address
Imam Khomeini Hospital; Ershad Blvd., Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3346 9931
Fax
+98 44 3346 9935
Email
pashaee.m@umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr Saber gholizadeh
Street address
Urmia University of Medical Sciences; Resalat Blvd., Urmia, Iran
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
Mohammad Reza Pashaei
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Hospital, Ershad Blvd., Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3346 9931
Email
pashaee.m@umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Mohammad Reza Pashaei
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Hospital, Ershad Blvd., Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3346 9931
Email
pashaee.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
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