| Trial ID: | L0768 |
| Source ID: | IRCT20110530006652N2
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| Associated Drug: |
Oleoylethanolamide
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| Title: |
The effect of Oleoylethanolamide supplementation on peroxisome proliferator-activated receptor alpha gene expression, pyroptosis pathway genes (TLR4, TRIF, MYD88, NLRP3, Caspase 1, Caspase 8, IL1?? and IL18), lipopolysaccharide binding protein, metabolic
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| Acronym: |
--
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| Status: |
Not Recruiting
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| Study Results: |
No Results Available
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| Results: |
--
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| Conditions: |
Non-alcoholic fatty liver disease. <br>Fatty (change of) liver, not elsewhere classified;K76.0
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| Interventions: |
Intervention 1: 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
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| Outcome Measures: |
Gene expression of PPAR-a. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Real time-PCR.;Serum levels of triglyceride. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: enzymatic kit.;Serum levels of total cholesterol. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: enzymatic kit.;Serum levels of High-Density Lipoprotein cholesterol (HDL-c). Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: enzymatic kit.;Serum levels of Low-Density Lipoprotein cholesterol (LDL-c). Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: enzymatic kit.;Fasting blood glucose levels. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: enzymatic kit.;Fasting insulin levels. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kit.;Gene expression of TLR4. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Real-time PCR.;Gene expression of NLRP3. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Real-time PCR.;Gene expression of Caspase1. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Real-time PCR.;Gene expression of IL18. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Real-time PCR.;Serum level of LBP. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kit.;Gene expression of MYD88. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Real-time PCR.;Gene expression of TRIF. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Real-time PCR.;Gene expression of Caspase 8. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Real-time PCR.;Gene expression of IL1- ??. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Real-time PCR.Serum levels of alanine transaminase (ALT). Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: enzymatic kit.;Serum levels of aspartate aminotransferase (AST). Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: enzymatic kit.;Severity of liver steatosis. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Ultrasonography.;Liver fibrosis score. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Non-alcoholic fatty liver disease (NAFLD) fibrosis score formula.;Dietary assessment. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Dietary recall.;Appetite assessment. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Visual analog scales (VAS).;Anthropometric incidies. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Waist circumference by a non-stretching measuring tape - BMI by dividing weight (kg) to height square (m2) - WHR by waist circumference/hip circumference.;Physical activity. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: The International Physical Activity Questionnaires (IPAQ).
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| Sponsor/Collaborators: |
Tabriz University of Medical Sciences
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| Gender: |
All
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| Age: |
20 years50 years
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| Phases: |
Phase 3
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| Enrollment: |
74
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| Study Type: |
interventional
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| Study Designs: |
Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Among volunteers to participate in the study, 74 individuals will be selected by simple randomization. Then the subjec
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| Start Date: |
07/02/2019
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
18 May 2020
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| Locations: |
Iran (Islamic Republic of)
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| URL: |
http://en.irct.ir/trial/37228
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