Assessment of Oleoylethanolamide supplementation on IL-6, IL-10 genes expression, their serum levels and body composition in obese patients with non-alcoholic fatty liver disease (NAFLD)
This double-blind randomized placebo-controlled clinical trial will be done with the aim of oleoylethanolamide (OEA) supplementation on the IL-6, IL-10 genes expression, their serum levels and body composition in obese patients with non-alcoholic fatty liver disease (NAFLD).
Design
This study will be done on sixty obese patients of both genders with NAFLD.
Settings and conduct
The study will be conducted in the nutrition faculty of Tabriz University of Medical Sciences and supplementation duration will be 12 weeks. The OEA and placebo sachets will be coded by the person responsible for preparing them, and the main investigators and the patients will be blinded to the type of the supplement each group receives.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Body mass index 30 to 40 kg/m2, and non-alcoholic fatty liver disease
Exclusion criteria: Use of drugs and supplements. smoking, pregnancy, breastfeeding, menopause, liver, kidney and gastrointestinal diseases, diabetes, heart failure, thyroid disorders
Intervention groups
patients in the OEA group will use two125 mg OEA capsules daily. In the placebo group, two 125 mg capsules of starch will be consumed daily.
Main outcome variables
The body composition percentage
The expression of IL-6 and IL-10 genes
serum levels of IL-6 and IL-10
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090609002017N32
Registration date:2018-08-11, 1397/05/20
Registration timing:registered_while_recruiting
Last update:2018-08-11, 1397/05/20
Update count:2
Registration date
2018-08-11, 1397/05/20
Registrant information
Name
Alireza Ostadrahimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
ostadrahimi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of Oleoylethanolamide supplementation on IL-6, IL-10 genes expression, their serum levels and body composition in obese patients with non-alcoholic fatty liver disease (NAFLD)
Public title
Assessment of Oleoylethanolamide supplementation in prevention and treatment of non-alcoholic fatty liver disease
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Ages between 20 to 50 years
body mass index (BMI) 30 to 40 kg/m2
Diagnosis of non-alcoholic fatty liver disease by a liver specialist based on ultrasound
Exclusion criteria:
Regular use of nonsteroidal anti-inflammatory agents (NSAIDs) and antibiotics
Use of hepatotoxic drugs such as phenytoin, amiodarone, levothyroxine, amoxifene, lithium
Use of antihypertensive drugs
Using weight loss and lipid-lowering drugs
Use of probiotic and prebiotic supplements; vitamins; minerals; antioxidants; and omega 3 supplements in the last 3 months
Smoking
Pregnancy
Breast-feeding
Menopause
Pathological conditions affecting the liver such as viral hepatitis, acute or chronic hepatic impairment, liver transplantation, acute systemic disease
Gastrointestinal diseases
Diabetes
Heart failure
Thyroid disorders
Kidney Diseases
Haemochromatosis
Wilson's disease
Alpha-1 antitrypsin deficiency
Autoimmune diseases
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are assigned to intervention and control groups using simple random design
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the main investigator and patients will be blind (oleoylethanolamide or placebo) .
The person responsible for preparing the supplement sachets (who is completely unrelated to the study) will be asked to assign a three digit code to each of the two powders (oleoylethanolamid and placebo), and keep the codes for himself until the end of the study and data analyses.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Tabriz University of Medical Sciences
Street address
Third Floor, Central Building (2), Tabriz University of Medical Sciences, Golghasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
00984133344280
Approval date
2018-05-21, 1397/02/31
Ethics committee reference number
IR.TBZMED.REC.1397.176
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
gene expression of IL-6
Timepoint
before intervention, and 3 months after intervention
Method of measurement
Real time-PCR
2
Description
gene expression of IL-10
Timepoint
before intervention, and 3 months after intervention
Method of measurement
Real time- PCR
3
Description
Serum levels of IL-6
Timepoint
before intervention, and 3 months after intervention
Method of measurement
By laboratory ELISA kits
4
Description
Serum levels of IL-10
Timepoint
Before intervention, and 3months after intervention
Method of measurement
By laboratory ELISA kits
Secondary outcomes
1
Description
Body composition
Timepoint
Before intervention, and 3 months after intervention
Method of measurement
Measurement of body composition, including fat mass, fat free mass and total body water determination using bioelectrical impedance analyser (BIA)
Intervention groups
1
Description
Intervention group: daily 2 capsules including 125 mg oleoylethanolamide
Category
Prevention
2
Description
Control group: daily 2 capsules including 125 mg placebo
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers of Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostadrahimi
Street address
Attar Neyshabouri Street, Golgasht Avenue, Nutrition faculty, Tabriz University of Medical Science, Ground Floor
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7580
Email
ostadrahimi@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research , Tabriz University of Medical Sciences, Nutrition Research Center