Assessment of oleoylethanolamide supplementattion on the peroxisome proliferator-activated receptor-α (PPAR-α) gene expression, some inflammatory biomarkers and the abundence of Akkermansia muciniphila bacteria in stool of obese people: A double-blind randomized placebo-controlled clinical trial
This double-blind randomized placebo-controlled clinical trial will be done with the aim of assessing oleoylethanolamide (OEA) supplementation on the peroxisome proliferator-activated receptor-α (PPAR-α) gene expression, inflammatory biomarkers including interleukin 6 (IL-6), tumor necrosis factor alpha (TNF-α), high-sensitivity C-reactive protein (hs-CRP), and Akkermansia Muciniphila abundance in the stool samples of obese people. Sixty healthy obese people of both genders with inclusion criteria will be divided into two intervention and control groups, randomly after completing a written consent form.
Inclusion criteria: Ages between 18 to 50 years; body mass index (BMI); 30 to 40 kg/m2
Exclusion criteria: Individuals with chronic and acute diseases; breastfeeding; pregnancy; menopause women; the use of probiotic; prebiotic; vitamins; minerals; omega 3 supplements; weight loss and lipid-lowering drugs and antibiotics over the past month.
Intervention group will take daily 2 capsules including 125 mg OEA and the control group will take the 125 mg placebo for 8 weeks. Anthropometric measurements, short form of physical activity questionnaire, appetite status questionnaire and food frequency questionnaire will be completed at baseline and at the end of study. The abundance of Akkermansia muciniphila bacteria in stool samples, the levels of inflammatory biomarkers and the gene expression of PPAR-α in the fasting blood samples will be assessed.
General information
Acronym
Assessment of oleoylethanolamide supplementattion in the prevention and treatment of obesity
IRCT registration information
IRCT registration number:IRCT201607132017N30
Registration date:2016-10-03, 1395/07/12
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2016-10-03, 1395/07/12
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
Vice-chancellor for Research of Tabriz University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of oleoylethanolamide supplementattion on the peroxisome proliferator-activated receptor-α (PPAR-α) gene expression, some inflammatory biomarkers and the abundence of Akkermansia muciniphila bacteria in stool of obese people: A double-blind randomized placebo-controlled clinical trial
Public title
Assessment of oleoylethanolamide supplementattion in the prevention and treatment of obesity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Ages between 18 to 50 years; body mass index (BMI) 30 to 40 kg/m2
Exclusion criteria: individuals with kidney and liver disorders; heart failure; rheumatic diseases; gastrointestinal diseases; smoking; breastfeeding; pregnancy; menopause; use of probiotic and prebiotic supplements; vitamins; minerals; omega 3 supplements; weight loss and lipid-lowering drugs; use of antibiotics over the past month
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-Chancellor for Research of Tabriz University of Medical Sciences
Street address
Third floor, Central Building(2), Tabriz University of Medical Scienes, Golgasht Avenue
City
Tabriz
Postal code
00989143135845
Approval date
2016-09-07, 1395/06/17
Ethics committee reference number
IR.TBZMED.REC.395.618
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, Golgasht Street
City
Tabriz
Postal code
00984133344280
Approval date
2016-09-07, 1395/06/17
Ethics committee reference number
IR.TBZMED.REC.1395.618
Health conditions studied
1
Description of health condition studied
obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
gene expression of PPAR-α
Timepoint
before anf after
Method of measurement
Real time-PCR
2
Description
inflammatory biomarkers (IL-6، TNF-α ، hs-CRP)
Timepoint
before and after
Method of measurement
IL-6 and TNF-α using ELISA, hs.CRP using spectrometry
3
Description
abundance of Akkermansia muciniphila bacteria in stool samples
Timepoint
before and after
Method of measurement
colony count
Secondary outcomes
1
Description
Anthropometric measurements
Timepoint
at baseline and at the end of intervention
Method of measurement
Using a stadiometertape and tape in accordance with the standards
2
Description
appetite status
Timepoint
at baseline and at the end of study
Method of measurement
Visual Analouge Scale questionnaire
Intervention groups
1
Description
intervention group: daily 2 capsules including 125 mg oleoylethanolamide
Category
Prevention
2
Description
control group: daily 2 capsule including 125 mg placebo
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Sheikhoilraies Clinic of Tabriz University of Medical Science
Full name of responsible person
Alireza Ostadrahimi
Street address
Attar Neyshaburi Street, Golgasht Avenue , Nutrition faculty, Tabriz University of Medical Science, Ground Floor
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research of Tabriz University of Medical Sciences
Full name of responsible person
Dr Alireza Ostadrahimi
Street address
Third floor, Central Building (2), Tabriz University of Medical Scienes, Golgasht Avenue
City
Tabriz
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 of Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Nutrition, Tabriz University of Medical Science