The effect of garlic powder supplementation on body composition, liver echogenicity, insulin resistance, liver enzymes, lipid profile and oxidative stress in patients with non alcoholic fatty liver disease
Determine The effect of garlic powder supplementation on body composition, liver echogenicity, insulin resistance, liver enzymes, lipid profile and oxidative stress in patients with non alcoholic fatty liver disease
Design
Clinical trial with control group, parallel groups, double blind, randomised
Settings and conduct
The present study aiming to evaluate The effect of garlic powder supplementation on body composition, liver echogenicity, insulin resistance, liver enzymes, lipid profile and oxidative stress in patients with non alcoholic fatty liver disease. this study will be conducted in imam khomeini hospital in urmia. This study is a double blinded parallel randomized controlled clinical trial. 90 Patients will be randomly allocated into two groups, including intervention group and the control group. in this study participants and investigator are in blinding protocol.
Participants/Inclusion and exclusion criteria
nclusion criteria: contracting non alcoholic fatty liver disease and age of between 18 and 75. Exclusion criteria: alcohol use; viral hepatitis; hepatocellular carcinoma; other causes of chronic liver disease; diabetes mellitus; untreated hypothyroidism; psychiatric disorder; kidney disease; pregnancy; and lactation; subjects with low blood pressure; allergy to garlic
Intervention groups
The intervention group will be consume 4 tablets of 400 miligrams per day garlic in addition to usual treatment for three months.
The control group will be consume 4 tablets of 400 miligrams per day placebo in addition to usual treatment for three months.
Main outcome variables
body composition; liver echogenicity; insulin resistance; liver enzymes; lipid profile; oxidative stress; systolic and diastolic blood pressure; intestinal function; Quantity of appetite; fatty liver index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170206032417N4
Registration date:2019-04-28, 1398/02/08
Registration timing:registered_while_recruiting
Last update:2019-04-28, 1398/02/08
Update count:0
Registration date
2019-04-28, 1398/02/08
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
2018-10-23, 1397/08/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of garlic powder supplementation on body composition, liver echogenicity, insulin resistance, liver enzymes, lipid profile and oxidative stress in patients with non alcoholic fatty liver disease
Public title
Effect of garlic powder in treatment of non alcoholic fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with non alcoholic fatty liver disease
age of between 18 and 75
Exclusion criteria:
alcohol use
viral hepatitis
hepatocellular carcinoma
other causes of chronic liver disease
diabetes mellitus
untreated hypothyroidism
psychiatric disorder
kidney disease
pregnancy
lactation
allergy to garlic
patients with low blood pressure
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Non-Alcoholic Fatty liver patients referred to the gastroenterology clinic of Imam Khomeini Hospital of Urmia were selected consecutively on the basis of inclusion and exclusion criteria from the date of 23 September until 22 December in year of 2018. The subjects that selected, randomly (using 45 cards 1 and 45 numbered 2 cards to the number of patients present in the study and randomly selecting the cards by the patients) divided into two groups of intervention (1) and control (2).
for double blinding, at the start of the study,in order to avoid any knowledge of the type of tablet taken by each group, the total number of packets containing garlic and placebo tablets by a person other than the researcher is encode in the form 1 and 2 and then are Available to the researcher.
Blinding (investigator's opinion)
Double blinded
Blinding description
patient and investigator
Placebo
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
Urmia University of Medical Sciences,orjans valley, Resalat boulevard
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2018-09-05, 1397/06/14
Ethics committee reference number
IR.UMSU.REC.1397.199
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, 6, 12
Method of measurement
scale. kg
2
Description
body mass index
Timepoint
At weeks 0, 6, 12
Method of measurement
Weight(kg)\[height(m)]2 , kg\m2
3
Description
Gamma Glutamyl transferase
Timepoint
At weeks 0, 6, 12
Method of measurement
Enzymatic method , IU\ Lit
4
Description
ALP
Timepoint
At weeks 0, 6, 12
Method of measurement
Enzymatic method , IU\ Lit
5
Description
Aspartat transaminase
Timepoint
At weeks 0, 6, 12
Method of measurement
Enzymatic method, IU\ Lit
6
Description
Alanine Aminotransferase
Timepoint
At weeks 0, 6, 12
Method of measurement
Enzymatic method, IU\ Lit
7
Description
Fasting blood sugar
Timepoint
At weeks 0, 6, 12
Method of measurement
Enzymatic method, IU\ Lit
8
Description
Serum insulin
Timepoint
At weeks 0, 12
Method of measurement
Radioimmunoassay
9
Description
Body fat mass
Timepoint
At weeks 0, 6, 12
Method of measurement
BIA, kg
10
Description
Skeletal muscle mass
Timepoint
At weeks 0, 6, 12
Method of measurement
BIA, kg
11
Description
Waist circumference
Timepoint
At weeks 0, 6, 12
Method of measurement
BIA, cm
12
Description
Hepatic steatosis
Timepoint
Before intervention and three month after intervention
Method of measurement
Ultrasonography
13
Description
HDL cholesterol
Timepoint
At weeks 0, 6, 12
Method of measurement
Enzymatic method, mg/dl
14
Description
Triglyceride
Timepoint
At weeks 0, 6, 12
Method of measurement
Enzymatic method, mg/dl
15
Description
LDL cholesterol
Timepoint
At weeks 0, 6, 12
Method of measurement
Enzymatic method, mg/dl
16
Description
Total cholesterol
Timepoint
At weeks 0, 6, 12
Method of measurement
Enzymatic method, mg/dl
17
Description
Total antioxidant capacity
Timepoint
At weeks 0, 12
Method of measurement
spectrophotometry, Nmol/l
18
Description
SOD
Timepoint
At weeks 0, 12
Method of measurement
spectrophotometry, Nmol/l
19
Description
MDA
Timepoint
At weeks 0, 12
Method of measurement
spectrophotometry, Nmol/l
20
Description
Systolic blood pressure
Timepoint
At weeks 0, 6, 12
Method of measurement
Mercury sphygmomanometer, mmHg
21
Description
Diastolic blood pressure
Timepoint
At weeks 0, 6, 12
Method of measurement
Mercury sphygmomanometer, mmHg
22
Description
FATTY LIVER INDEX
Timepoint
At weeks 0, 6, 12
Method of measurement
Formula
23
Description
Quantity of appetite
Timepoint
At weeks 0, 6, 12
Method of measurement
VAS questionnaire
24
Description
Intestinal function
Timepoint
At weeks 0, 6, 12
Method of measurement
Bristol stool questionaire
25
Description
HOMA-IR
Timepoint
At weeks 0, 12
Method of measurement
Formula
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will be consume 4 tablets of 400 miligrams per day garlic in addition to usual treatment for three months.
Category
Treatment - Drugs
2
Description
Control group: The control group will be consume 4 tablets of 400 miligrams per day placebo in addition to usual treatment for three months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini 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
Vice Chancellor for research of Urmia University of Medical Sciences
Full name of responsible person
Dr Iraj Mohebbi
Street address
Orjhans Street, Resalat Blvd, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 21 8753 2210
Email
irajmohebi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Urmia 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
Specialty Doctorte Degree in Nutritioal Science/ Urmia University of Medical Sciences Associate Prof
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Department, Faculty of Medicine, College of Medicine, Urmia University of Medical Science, 11th km of Nazloo Road, 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
Specialty Doctorte Degree in Nutritioal Science/ Urmia University of Medical Sciences Associate Prof
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Department, Faculty of Medicine, College of Medicine, Urmia University of Medical Science, 11th km of Nazloo Road, 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
abbas ali sangouni
Position
MSc Student of nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
. Nutrition Department, Faculty of Medicine, College of Medicine, Urmia University of Medical Science, 11th km of Nazloo Road, Urmia
City
urmia
Province
West Azarbaijan
Postal code
5715799313
Phone
+98 44 3275 2375
Email
abas.sangouni@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