The effect of oleoylethanolamide supplementation on peroxisome proliferator-activated receptor alpha gene expression, metabolic parameters and anthropometric indices in obese patients with non-alcoholic fatty liver disease
The aim of the present study is to investigate the effects of oleoylethanolamide supplementation on peroxisome proliferator-activated receptor alpha gene expressions, metabolic parameters and anthropometric indices in obese patients with non-alcoholic fatty liver disease
Design
Randomized double-blind clinical trial with two arm parallel groups
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 oleoylethanolamide 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 oleoylethanolamide (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 expression of the peroxisome proliferator-activated receptor alpha (PPAR-α) gene, the metabolic parameters, serum levels of alanine transaminase (ALT) and aspartate transfusion aminease (AST), the severity of liver steatosis, liver fibrosis score, dietary pattern, appetite sensations, and anthropometric indices
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110530006652N2
Registration date:2019-02-07, 1397/11/18
Registration timing:prospective
Last update:2019-02-07, 1397/11/18
Update count:1
Registration date
2019-02-07, 1397/11/18
Registrant information
Name
Maryam Saghafi asl
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7581
Email address
saghafiaslm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-09, 1398/01/20
Expected recruitment end date
2020-03-05, 1398/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oleoylethanolamide supplementation on peroxisome proliferator-activated receptor alpha gene expression, metabolic parameters and anthropometric indices in obese patients with non-alcoholic fatty liver disease
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
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
From among the patients who volunteer to participate in the study, 74 individuals will be selected by simple randomization. Then by using the Random Allocation Software, the subjects will be allocated into either intervention or placebo group, based on gender and degree of fatty liver.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the main investigator and patients will be blind of the type of supplement (oleoylethanolamide or placebo) . The person who is 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
2018-11-19, 1397/08/28
Ethics committee reference number
IR.TBZMED.REC.1397.694
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 PPAR-α
Timepoint
Before intervention, and 3 months after intervention
Method of measurement
Real time-PCR
2
Description
Serum levels of triglyceride
Timepoint
Before intervention, and 3 months after intervention
Method of measurement
Use of an enzymatic kit method
3
Description
Serum levels of total cholesterol
Timepoint
Before intervention, and 3 months after intervention
Method of measurement
Use of an enzymatic kit method
4
Description
Serum levels of High-Density Lipoprotein cholesterol (HDL-c)
Timepoint
Before intervention, and 3 months after intervention
Method of measurement
Use of an enzymatic kit method
5
Description
Serum levels of Low-Density Lipoprotein cholesterol (LDL-c)
Timepoint
Before intervention, and 3 months after intervention
Method of measurement
Use of an enzymatic kit method
6
Description
Fasting blood glucose levels
Timepoint
Before intervention, and 3 months after intervention
Method of measurement
Use of an enzymatic kit method
7
Description
Fasting insulin levels
Timepoint
Before intervention, and 3 months after intervention
Method of measurement
Enzyme-linked immunosorbent assay (ELISA) kit
Secondary outcomes
1
Description
Serum levels of alanine transaminase (ALT)
Timepoint
Before intervention, and 3months after intervention
Method of measurement
Use of an enzymatic kit method
2
Description
Serum levels of aspartate aminotransferase (AST)
Timepoint
Before intervention, and 3 months after intervention
Method of measurement
Use of an enzymatic kit method
3
Description
Severity of liver steatosis
Timepoint
Before intervention, and 3 months after intervention
Method of measurement
Ultrasonography
4
Description
Liver fibrosis score
Timepoint
قبل مداخله و سه ماه پس از شروع مداخله
Method of measurement
Non-alcoholic fatty liver disease (NAFLD) fibrosis score formula
5
Description
Dietary assessment
Timepoint
Before intervention, and 3 months after intervention
Method of measurement
A three-day dietary record
6
Description
Appetite assessment
Timepoint
Before intervention, and 3 months after intervention
Method of measurement
Visual analog scales (VAS)
7
Description
Anthropometric incidies
Timepoint
Before intervention, and 3 months after intervention
Method of measurement
Waist circumference will be measured at a level midway between the lower rib margin and iliac crest with the tape all around the bare body in horizontal position without the pressure on the skin, BMI: weight (kg)/height (m) 2 WHR: waist circumference/hip circumference
8
Description
Physical activity
Timepoint
Before intervention, and 3 months after intervention
Method of measurement
The International Physical Activity Questionnaires (IPAQ)
Intervention groups
1
Description
Intervention group: Patients in this group will receive weight loss diet and oleylethanolamide supplements (125 mg) for 12 weeks. Oleylethanolamide supplement is made in Iran, and twice a day before lunch and dinner will be consumed.
Category
Prevention
2
Description
Patients in this group will receive weight loss diet with placebo for 12 weeks. The placebo is starch (125 mg) and twice a day before lunch and dinner will be consumed.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers of Tabriz University of Medical Sciences
Full name of responsible person
Maryam Saghafi-Asl
Street address
Attar Neyshabouri Street, Golgasht Avenue, Nutrition faculty, Tabriz University of Medical Science, Ground Floor