The purpose of this study is to investigate the effect of phtosterol supplementation on serum levels of inflammatory markers, liver enzymes, leptin, adiponectin in patients with non alcoholic fatty liver disease. This Controlled, double-blind, randomized clinical trial will perform on 42 patients. Patients will randomly divide into 2 groups: The case and control group will receive phytosterols supplement (1.6 g per day) and starch (1.6 g per day) as placebo respectively, for 2 months. Variables including anthropometric indicators, blood pressure, inflammatory markers, liver enzymes, fasting blood sugar and lipid profile will measure before and after of intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011531958N1
Registration date:2017-02-20, 1395/12/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-20, 1395/12/02
Registrant information
Name
mohammad ali javanmardi
Name of organization / entity
jondishapur university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3825 0550
Email address
javanmardi.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Ahvaz jondishapur University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of phytosterols supplementation on serum levels of inflammatory markers ,liver enzymes ,lipid profiles ,Adiponectin ,Leptin and fasting blood sugar in non-alcoholic fatty liver disease patients
Public title
effect of phytosterols on non alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 19-59 years old patient with non alcoholic fatty liver disease Exclusion criteria: Patients who have diabetes, cardiovascular, kidney and other hepatic diseases; Pregnant or lactating women; Smoking; Alcohol consumption; Use of dietary supplements
Age
From 19 years old to 59 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Jondishapur University Of Medical Sciences, Golestan Ave. Ahvaz
City
ahvaz
Postal code
6165777696
Approval date
2017-02-12, 1395/11/24
Ethics committee reference number
IR.AJUMS.REC.1395.718
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
Aspartate aminotransferase
Timepoint
Before intervention and 2 months after intervention
Method of measurement
blood test
2
Description
Alanine aminotransferase
Timepoint
Before intervention and 2 months after intervention
Method of measurement
blood test
3
Description
Gamma-glutamyl transpeptidase
Timepoint
Before intervention and 2 months after intervention
Method of measurement
blood test
4
Description
Interlukine-6
Timepoint
Before intervention and 2 months after intervention
Method of measurement
blood test
5
Description
hs-CRP
Timepoint
Before intervention and 2 months after intervention
Method of measurement
blood test
6
Description
TNF-α
Timepoint
Before intervention and 2 months after intervention
Method of measurement
blood test
7
Description
Total cholestrol
Timepoint
Before intervention and 2 months after intervention
Method of measurement
blood test
8
Description
LDL-C
Timepoint
Before intervention and 2 months after intervention
Method of measurement
blood test
9
Description
HDL-C
Timepoint
Before intervention and 2 months after intervention
Method of measurement
blood test
10
Description
Triglyciride
Timepoint
Before intervention and 2 months after intervention
Method of measurement
blood test
11
Description
VLDL
Timepoint
Before intervention and 2 months after intervention
Method of measurement
TG/5
12
Description
Adiponectin
Timepoint
Before intervention and 2 months after intervention
Method of measurement
blood test
13
Description
Leptin
Timepoint
Before intervention and 2 months after intervention
Method of measurement
blood test
14
Description
Fasting blood sugar
Timepoint
Before intervention and 2 months after intervention
Method of measurement
blood test
Secondary outcomes
1
Description
Blood pressure
Timepoint
Before intervention and 2 months after intervention
Method of measurement
By manometer according to mmHg
2
Description
Body weight
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Digital scale
3
Description
Body mass index
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Body weight in kilograms divided by height squared in meters
4
Description
Waist circumference
Timepoint
Before intervention and 2 months after intervention
Method of measurement
By measuring tape according to meter
5
Description
Hip circumference
Timepoint
Before intervention and 2 months after intervention
Method of measurement
By measuring tape according to meter
Intervention groups
1
Description
Intervention group : daily consumption of 400 mg phytosterols supplement (twice a day and each time 2 tabs=1.6 g) for 60 days
Category
Treatment - Drugs
2
Description
control group : daily consumption of 400 mg starch (twice a day and each time 2 tabs=1.6 g) for 60 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastroenterology Clinic of Golestan Hospital
Full name of responsible person
Street address
City
ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jondishapur University Of Medical Sciences
Full name of responsible person
dr.nader saki
Street address
Ahvaz Jondishapur University Of Medical Sciences, Golestan Ave. Ahvaz
City
ahvaz
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, Ahvaz Jondishapur University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Paramedicine, Ahvaz Jondishapur University Of Medical Sciences
Full name of responsible person
mohammad ali javanmardi
Position
Msc. in Nutrition sciences
Other areas of specialty/work
Street address
Ahvaz Jondishapur University of Medical Sciences, Golestan Ave. Ahvaz