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Assessment of oleoylethanolamide supplementation on the expression of SIRT1, AMPK, PGC-1α, PPAR-γ, CEBP-α, CEBP- β, 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 disease (NAFLD)

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History
# Registration date Revision Id
3 2022-05-16, 1401/02/26 239204
2 2021-05-14, 1400/02/24 182676
1 2018-08-11, 1397/05/20 55987
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  • Protocol summary

    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).
    This double-blind randomized placebo-controlled clinical trial will be done with the aim of oleoylethanolamide (OEA) supplementation on the SIRT1, AMPK, PGC1-α, PPAR-γ, CEBP-α, CEBP-β, IL-6, and IL-10 genes expression, and serum levels of IL-6, IL-10, and NRG-4, and body composition in obese patients with non-alcoholic fatty liver disease (NAFLD).
    مطالعه کار آزمایی بالینی تصادفی کنترل دار دوسوکور حاضر با هدف تاثیرمکمل یاری اولئیل اتانول آمید (OEA) بر بیان ژنهای IL-6 و IL-10، سطوح سرمی آنها و ترکیب بدنی در بیماران مبتلا به کبد چرب غیر الکلی چاق (NAFLD) انجام خواهد شد. .
    مطالعه کار آزمایی بالینی تصادفی کنترل دار دوسوکور حاضر با هدف تاثیرمکمل یاری اولئیل اتانول آمید (OEA) بر بیان ژنهای SIRT1 و AMPK و PGC-1α و PPAR-γ و CEBP-α و CEBP-β و IL-6 و IL-10 و سطوح سرمی IL-6 و IL-10 و NRG-4 و ترکیب بدنی در بیماران مبتلا به کبد چرب غیر الکلی چاق (NAFLD) انجام خواهد شد. .
    The body composition percentage The expression of IL-6 and IL-10 genes serum levels of IL-6 and IL-10
    The body composition percentage The expression of SIRT1, AMPK, PGC-1α, PPAR-γ, CEBP-α, CEBP-β, IL-6, and IL-10 genes serum levels of IL-6 and IL-10
    درصد ترکیب بدن میزان بیان ژنهای IL-6 و IL-10 سطوح سرمی IL-6 و IL-10
    درصد ترکیب بدن میزان بیان ژنهای SIRT1 و AMPK و PGC-1α و PPAR-γ و CEBP-α و CEBP-β و IL-6 و IL-10 سطوح سرمی IL-6 و IL-10 و NRG-4

  • General information

    2018-07-23, 1397/05/01
    2019-04-21, 1398/02/01
    2019-08-23, 1398/06/01
    2020-01-21, 1398/11/01
    empty
    To add the effects of oleoylethanolamide (OEA) supplementation on the expression of SIRT1, AMPK, PGC-1α, PPAR-γ, CEBP-α, and CEBP- β genes and serum NRG4 levels.
    empty
    اضافه کردن بررسی تاثیر مکمل یاری اولئیل اتانول آمید (OEA) بر بیان ژنهای AMPK، SIRT1 CEBP- β , CEBP-α، PPAR-γ، PGC-1α و سطوح سرمی NRG-4
    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)
    Assessment of oleoylethanolamide supplementation on the expression of SIRT1, AMPK, PGC-1α, PPAR-γ, CEBP-α, CEBP- β, 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 disease (NAFLD)
    بررسی تاثیر مکمل یاری اولئیل اتانول آمید (OEA) بر بیان ژنهای IL-6 و IL-10، سطوح سرمی آنها و ترکیب بدنی دربیماران مبتلا به کبد چرب غیر الکلی چاق (NAFLD)
    بررسی تاثیر مکمل یاری اولئیل اتانول آمید (OEA) بر بیان ژنهای SIRT1 وAMPK و PGC-1α و PPAR-γ و CEBP-α و CEBP- β و IL-6 و IL-10 و سطوح سرمی IL-6 و IL-10 و NRG-4 و ترکیب بدنی در بیماران بزرگسال مبتلا به کبد چرب غیر الکلی چاق (NAFLD)

  • Ethics committees

    #1
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    2020-12-28, 1399/10/08
    empty
    IR.TBZMED.REC.1399.908

  • Primary outcomes

    #1
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    Serum levels of NRG-4
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    سطوح سرمی NRG-4
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    Before intervention, and 3months after intervention
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    قبل مداخله و سه ماه پس از شروع مداخله
    empty
    By laboratory ELISA kits
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    کیت الایزا
    #2
    empty
    gene expression of SIRT1
    empty
    بیان ژن SIRT1
    empty
    before intervention, and 3 months after intervention
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    قبل مداخله و سه ماه پس از شروع مداخله
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    Real time-PCR
    empty
    Real time-PCR
    #3
    empty
    gene expression of AMPK
    empty
    بیان ژن AMPK
    empty
    before intervention, and 3 months after intervention
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    قبل مداخله و سه ماه پس از شروع مداخله
    empty
    Real time-PCR
    empty
    Real time-PCR
    #4
    empty
    gene expression of PGC-1α
    empty
    بیان ژن PGC-1α
    empty
    before intervention, and 3 months after intervention
    empty
    قبل مداخله و سه ماه پس از شروع مداخله
    empty
    Real time-PCR
    empty
    Real time-PCR
    #5
    empty
    gene expression of PPAR-γ
    empty
    بیان ژن PPAR-γ
    empty
    before intervention, and 3 months after intervention
    empty
    قبل مداخله و سه ماه پس از شروع مداخله
    empty
    Real time-PCR
    empty
    Real time-PCR
    #6
    empty
    gene expression of CEBP-α
    empty
    بیان ژن CEBP-α
    empty
    before intervention, and 3 months after intervention
    empty
    قبل مداخله و سه ماه پس از شروع مداخله
    empty
    Real time-PCR
    empty
    Real time-PCR
    #7
    empty
    gene expression of CEBP-β
    empty
    بیان ژن CEBP-β
    empty
    before intervention, and 3 months after intervention
    empty
    قبل مداخله و سه ماه پس از شروع مداخله
    empty
    Real time-PCR
    empty
    Real time-PCR

Protocol summary

Study aim
This double-blind randomized placebo-controlled clinical trial will be done with the aim of oleoylethanolamide (OEA) supplementation on the SIRT1, AMPK, PGC1-α, PPAR-γ, CEBP-α, CEBP-β, IL-6, and IL-10 genes expression, and serum levels of IL-6, IL-10, and NRG-4, 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 SIRT1, AMPK, PGC-1α, PPAR-γ, CEBP-α, CEBP-β, IL-6, and IL-10 genes serum levels of IL-6 and IL-10

General information

Reason for update
To add the effects of oleoylethanolamide (OEA) supplementation on the expression of SIRT1, AMPK, PGC-1α, PPAR-γ, CEBP-α, and CEBP- β genes and serum NRG4 levels.
Acronym
IRCT registration information
IRCT registration number: IRCT20090609002017N32
Registration date: 2018-08-11, 1397/05/20
Registration timing: prospective

Last update: 2021-05-15, 1400/02/25
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
2019-04-21, 1398/02/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of oleoylethanolamide supplementation on the expression of SIRT1, AMPK, PGC-1α, PPAR-γ, CEBP-α, CEBP- β, 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 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

2

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
2020-12-28, 1399/10/08
Ethics committee reference number
IR.TBZMED.REC.1399.908

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

5

Description
Serum levels of NRG-4
Timepoint
Before intervention, and 3months after intervention
Method of measurement
By laboratory ELISA kits

6

Description
gene expression of SIRT1
Timepoint
before intervention, and 3 months after intervention
Method of measurement
Real time-PCR

7

Description
gene expression of AMPK
Timepoint
before intervention, and 3 months after intervention
Method of measurement
Real time-PCR

8

Description
gene expression of PGC-1α
Timepoint
before intervention, and 3 months after intervention
Method of measurement
Real time-PCR

9

Description
gene expression of PPAR-γ
Timepoint
before intervention, and 3 months after intervention
Method of measurement
Real time-PCR

10

Description
gene expression of CEBP-α
Timepoint
before intervention, and 3 months after intervention
Method of measurement
Real time-PCR

11

Description
gene expression of CEBP-β
Timepoint
before intervention, and 3 months after intervention
Method of measurement
Real time-PCR

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
Full name of responsible person
Dr Alireza Ostadrahimi
Street address
Nutrition Faculty, Attar Neishabouri Street, Golgasht Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7580
Email
ostadrahimi@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research , Tabriz University of Medical Sciences, Nutrition Research Center
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Nutrition Faculty, Tabriz University of Medical Sciences
Full name of responsible person
Helda Tutunchi
Position
Ph.D Candidate
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Nutrition Faculty, Attar Neyshabouri Avenue, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7580
Email
helda.nutrition@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nutrition Faculty, Tabriz University of Medical Sciences
Full name of responsible person
Dr Alireza Ostadrahimi
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutritional faculty, Attar Neyshabouri Street, Golgasht Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7580
Email
ostadrahimi@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Nutrition faculty, Tabriz University of Medical Sciences
Full name of responsible person
Helda Tutunchi
Position
Ph.D candidate
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Nutrition Faculty, Atttar Neyshabouri Avenue, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7580
Email
helda.nutrition@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data collected for the primary outcomes will be shared.
When the data will become available and for how long
access starting 12 months after publication
To whom data/document is available
The data will only be available for people working in academic institutions.
Under which criteria data/document could be used
The data of the present study will only be accessible by other researchers,  for conducting Meta-analysis.
From where data/document is obtainable
The researchers (student and her supervisor)
What processes are involved for a request to access data/document
Request a document via email
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