Protocol summary
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Study aim
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The aim of the present study is to investigate the effects of Oleoylethanolamide supplementation on peroxisome proliferator-activated receptor alpha gene expression, pyroptosis pathway genes (TLR4, TRIF, MYD88, NLRP3, Caspase 1, Caspase 8, IL1β and IL18), lipopolysaccharide binding protein, metabolic parameters, and anthropometric indices in peripheral blood mononuclear cells in obese NAFLD patients.
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Design
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Randomized triple-blinded controlled clinical trial with two arm parallel groups
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Settings and conduct
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The study will be conducted in School of Nutrition and Food Sciences of Tabriz University of Medical Sciences and duration of intervention will be 12 weeks. The Oleoylethanolamide and placebo capsules will be prepared and coded by the person responsible, and the main investigator and the patients will be blinded to the type of the supplement for each group.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Age between 20 to 50 years old, body mass index of 30 to 40 kg/m2 and non-alcoholic fatty liver disease based on ultrasonography - Exclusion criteria: Use of drugs and supplements, pregnancy, breastfeeding, liver, kidney and gastrointestinal diseases, diabetes, heart failure and thyroid disorders
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Intervention groups
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Patients in the Oleoylethanolamide (OEA) group will take two 125 mg OEA capsules daily. In the placebo group, two 125 mg starch capsules will be consumed daily.
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Main outcome variables
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The expression of the peroxisome proliferator-activated receptor alpha gene expression, pyroptosis pathway genes (TLR4, TRIF, MYD88, NLRP3, Caspase 1, Caspase 8, IL1β, and IL18), lipopolysaccharide binding protein, metabolic parameters, anthropometric indices, serum levels of alanine transaminase (ALT) and aspartate transfusion aminease (AST), the severity of liver steatosis, liver fibrosis score, dietary pattern and appetite sensations
General information
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Reason for update
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Adding information of two further studies related to this project
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20110530006652N2
Registration date:
2019-02-07, 1397/11/18
Registration timing:
prospective
Last update:
2020-05-09, 1399/02/20
Update count:
1
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Registration date
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2019-02-07, 1397/11/18
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-04-09, 1398/01/20
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Expected recruitment end date
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2020-03-05, 1398/12/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of Oleoylethanolamide supplementation on peroxisome proliferator-activated receptor alpha gene expression, pyroptosis pathway genes (TLR4, TRIF, MYD88, NLRP3, Caspase 1, Caspase 8, IL1β and IL18), lipopolysaccharide binding protein, metabolic parameters, and anthropometric indices in obese patients with non-alcoholic fatty liver disease
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Public title
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Evaluation of Oleoylethanolamide supplementation in the prevention and treatment of non-alcoholic fatty liver disease
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age between 20 to 50 years old
Body mass index (BMI) of 30 to 40 Kg/m2
Diagnosis of non-alcoholic fatty liver disease by a radiologist based on ultrasonography
Exclusion criteria:
Regular use of non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics and corticosteroids
Use of hormonal drugs, hepatotoxic drugs (such as Phenytoin, Amiodarone, Levothyroxine, Tamoxifene and Lithium), anti-hypertensive drugs, weight loss and lipid lowering drugs
Use of prebiotic and probiotic supplements, vitamins, minerals, antioxidants, and omega 3 supplements
Diagnosed pathological conditions affecting the liver such as liver transplantation, acute or chronic hepatic impairment, viral hepatitis, cystic fibrosis, Haemochromatosis, Wilson's disease, Alpha-1 antitrypsin deficiency, and acute systemic disease
Diagnosed thyroid disorders
Diagnosed kidney diseases
Diagnosed gastrointestinal diseases (e.g. Celiac disease)
Diagnosed diabetes
Diagnosed heart failure
Diagnosed autoimmune diseases
Diagnosed malignancies
Diagnosed severe psychological disorders
Pregnancy and lactation
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Age
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From 20 years old to 50 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Data analyser
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Sample size
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Target sample size:
74
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Among volunteers to participate in the study, 74 individuals will be selected by simple randomization. Then the subjects will be allocated into either intervention or placebo group by the Random Allocation Software, based on their gender and grade of fatty liver.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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In this study, the main investigator, the patients and the data analyst will be blinded to the supplement type (Oleoylethanolamide or placebo).
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-11-19, 1397/08/28
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Ethics committee reference number
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IR.TBZMED.REC.1397.694
2
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Ethics committee
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Approval date
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2020-01-21, 1398/11/01
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Ethics committee reference number
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IR.TBZMED.REC.1398.1131
3
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Ethics committee
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Approval date
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2020-02-04, 1398/11/15
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Ethics committee reference number
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IR.TBZMED.REC.1398.1175
Health conditions studied
1
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Description of health condition studied
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Non-alcoholic fatty liver disease
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ICD-10 code
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K76.0
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ICD-10 code description
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Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
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Description
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Gene expression of PPAR-α
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Timepoint
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Before the intervention and 3 months after the intervention
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Method of measurement
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Real time-PCR
2
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Description
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Serum levels of triglyceride
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Timepoint
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Before the intervention and 3 months after the intervention
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Method of measurement
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enzymatic kit
3
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Description
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Serum levels of total cholesterol
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Timepoint
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Before the intervention and 3 months after the intervention
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Method of measurement
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enzymatic kit
4
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Description
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Serum levels of High-Density Lipoprotein cholesterol (HDL-c)
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Timepoint
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Before the intervention and 3 months after the intervention
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Method of measurement
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enzymatic kit
5
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Description
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Serum levels of Low-Density Lipoprotein cholesterol (LDL-c)
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Timepoint
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Before the intervention and 3 months after the intervention
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Method of measurement
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enzymatic kit
6
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Description
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Fasting blood glucose levels
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Timepoint
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Before the intervention and 3 months after the intervention
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Method of measurement
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enzymatic kit
7
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Description
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Fasting insulin levels
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Timepoint
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Before the intervention and 3 months after the intervention
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Method of measurement
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Enzyme-linked immunosorbent assay (ELISA) kit
8
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Description
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Gene expression of TLR4
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Timepoint
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Before the intervention and 3 months after the intervention
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Method of measurement
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Real-time PCR
9
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Description
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Gene expression of NLRP3
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Timepoint
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Before the intervention and 3 months after the intervention
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Method of measurement
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Real-time PCR
10
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Description
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Gene expression of Caspase1
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Timepoint
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Before the intervention and 3 months after the intervention
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Method of measurement
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Real-time PCR
11
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Description
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Gene expression of IL18
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Timepoint
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Before the intervention and 3 months after the intervention
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Method of measurement
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Real-time PCR
12
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Description
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serum level of LBP
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Timepoint
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Before the intervention and 3 months after the intervention
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Method of measurement
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Enzyme-linked immunosorbent assay (ELISA) kit
13
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Description
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Gene expression of MYD88
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Timepoint
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Before the intervention and 3 months after the intervention
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Method of measurement
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Real-time PCR
14
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Description
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Gene expression of TRIF
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Timepoint
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Before the intervention and 3 months after the intervention
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Method of measurement
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Real-time PCR
15
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Description
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Gene expression of Caspase 8
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Timepoint
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Before the intervention and 3 months after the intervention
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Method of measurement
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Real-time PCR
16
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Description
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Gene expression of IL1- β
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Timepoint
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Before the intervention and 3 months after the intervention
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Method of measurement
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Real-time PCR
Secondary outcomes
1
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Description
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Serum levels of alanine transaminase (ALT)
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Timepoint
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Before the intervention and 3 months after the intervention
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Method of measurement
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enzymatic kit
2
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Description
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Serum levels of aspartate aminotransferase (AST)
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Timepoint
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Before the intervention and 3 months after the intervention
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Method of measurement
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enzymatic kit
3
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Description
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Severity of liver steatosis
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Timepoint
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Before the intervention and 3 months after the intervention
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Method of measurement
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Ultrasonography
4
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Description
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Liver fibrosis score
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Timepoint
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Before the intervention and 3 months after the intervention
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Method of measurement
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Non-alcoholic fatty liver disease (NAFLD) fibrosis score formula
5
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Description
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Dietary assessment
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Timepoint
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Before the intervention and 3 months after the intervention
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Method of measurement
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Dietary recall
6
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Description
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Appetite assessment
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Timepoint
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Before the intervention and 3 months after the intervention
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Method of measurement
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Visual analog scales (VAS)
7
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Description
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Anthropometric incidies
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Timepoint
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Before the intervention and 3 months after the intervention
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Method of measurement
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Waist circumference by a non-stretching measuring tape - BMI by dividing weight (kg) to height square (m2) - WHR by waist circumference/hip circumference
8
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Description
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Physical activity
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Timepoint
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Before the intervention and 3 months after the intervention
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Method of measurement
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The International Physical Activity Questionnaires (IPAQ)
Intervention groups
1
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Description
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Intervention group: Patients in this group will receive a weight-loss diet (500 Kcal less than current intake) and Oleylethanolamide supplements (125 mg) for 12 weeks. The Oleylethanolamide supplements are made in Islamic Republic of Iran and will be consumed twice (before lunch and dinner) daily .
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Category
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Treatment - Drugs
2
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Description
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Control group: Patients in this group will receive a weight-loss diet (500 Kcal less than current intake) with placebo for 12 weeks. The placebo is starch (125 mg) and will be consumed twice daily before lunch and dinner.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Publication of Results
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When the data will become available and for how long
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After finishing and publishing the project article
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To whom data/document is available
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University researchers
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Under which criteria data/document could be used
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With permission from the project researcher and the supporting organization (Nutrition Research Center and the Deputy of Research)
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From where data/document is obtainable
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Dr. Maryam Saghafi-Asl - School of Nutrition and Food Sciences, Tabriz University of Medical Sciences - Email: Saghafiaslm@gmail.com
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What processes are involved for a request to access data/document
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The recipient can send a request to the study corresponding person via email
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Comments
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