Clinical Trial Details

Trial ID: L0490
Source ID: IRCT20090609002017N32
Associated Drug: Oleoylethanolamide
Title: Assessment of oleoylethanolamide supplementation on the expression of SIRT1, AMPK, PGC-1a, PPAR-?, CEBP-a, CEBP- ??, IL-6, and IL-10 genes, serum IL-6, IL-10, and NRG-4 levels, and body composition in obese patients with non-alcoholic fatty liver diseas
Acronym: --
Status: Not Recruiting
Study Results: No Results Available
Results: --
Conditions: Non-alcoholic fatty liver disease. <br>Fatty (change of) liver, not elsewhere classified;K76.0
Interventions: Intervention 1: Intervention group: daily 2 capsules including 125 mg oleoylethanolamide. Intervention 2: Control group: daily 2 capsules including 125 mg placebo.
Outcome Measures: Gene expression of IL-6. Timepoint: before intervention, and 3 months after intervention. Method of measurement: Real time-PCR.;Gene expression of IL-10. Timepoint: before intervention, and 3 months after intervention. Method of measurement: Real time- PCR.;Serum levels of IL-6. Timepoint: before intervention, and 3 months after intervention. Method of measurement: By laboratory ELISA kits.;Serum levels of IL-10. Timepoint: Before intervention, and 3months after intervention. Method of measurement: By laboratory ELISA kits.;Serum levels of NRG-4. Timepoint: Before intervention, and 3months after intervention. Method of measurement: By laboratory ELISA kits.;Gene expression of SIRT1. Timepoint: before intervention, and 3 months after intervention. Method of measurement: Real time-PCR.;Gene expression of AMPK. Timepoint: before intervention, and 3 months after intervention. Method of measurement: Real time-PCR.;Gene expression of PGC-1a. Timepoint: before intervention, and 3 months after intervention. Method of measurement: Real time-PCR.;Gene expression of PPAR-?. Timepoint: before intervention, and 3 months after intervention. Method of measurement: Real time-PCR.;Gene expression of CEBP-a. Timepoint: before intervention, and 3 months after intervention. Method of measurement: Real time-PCR.;Gene expression of CEBP-??. Timepoint: before intervention, and 3 months after intervention. Method of measurement: Real time-PCR.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).
Sponsor/Collaborators: Vice chancellor for research , Tabriz University of Medical Sciences, Nutrition Research Center
Gender: All
Age: 20 years50 years
Phases: Not applicable
Enrollment: 60
Study Type: interventional
Study Designs: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Samples are assigned to intervention and control groups using simple random design, Blinding description: In this stu
Start Date: 11/08/2018
Completion Date: --
Results First Posted: --
Last Update Posted: 26 May 2021
Locations: Iran (Islamic Republic of)
URL: http://en.irct.ir/trial/31612