Protocol summary
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Study aim
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The effect of Oleoylethanolamide supplementation on the total antioxidant capacity, lipid profiles, fasting blood glucose, and food intake in obese people
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Design
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randomized double blind clinical trial
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Settings and conduct
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educational centers and clinics of Tabriz university of medical scieces
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Participants/Inclusion and exclusion criteria
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inclusion criteria: ages between 18-59, BMI= 30-40 kg/m2
Exclusion criteria: kidney and liver diseases, heart failure, rheumatic diseases, gastrointestinal diseases, smoking, lactation , pregnancy, menopause, taking peobiotics and prebiotics supplement vitamins, omega 3 and weight losing drugs and antibiotics in the past one month
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Intervention groups
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The intervention group two 125 mg oleylethanolamide capsules daily
Control group similar amounts of placebo (starch)
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Main outcome variables
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serum levels of total antioxidant capacity, fasting blood glucose, lipid profiles, dietary intake
General information
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Reason for update
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Acronym
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Assessment of oleoylethanolamide supplementattion in the prevention and treatment of obesity
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IRCT registration information
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IRCT registration number:
IRCT201607132017N30
Registration date:
2016-10-03, 1395/07/12
Registration timing:
registered_while_recruiting
Last update:
2019-08-30, 1398/06/08
Update count:
1
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Registration date
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2016-10-03, 1395/07/12
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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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Vice-chancellor for Research of Tabriz University of Medical Sciences
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Expected recruitment start date
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2016-09-22, 1395/07/01
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Expected recruitment end date
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2018-04-21, 1397/02/01
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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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Assessment of oleoylethanolamide supplementattion on the peroxisome proliferator-activated receptor-α (PPAR-α) gene expression, some inflammatory biomarkers, total antioxidant capacity, lipid profiles, fasting blood glucose, food intake and the abundence of Akkermansia muciniphila bacteria in stool of obese people: A double-blind randomized placebo-controlled clinical trial
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Public title
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Assessment of oleoylethanolamide supplementattion in the prevention and treatment of obesity
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
healthy obese subjects in both genders (males and females)
Ages between 18 to 59 years
body mass index 30-40 kg/m2
Exclusion criteria:
having kidney problems, liver failure, heart failure, rheumatic diseases and gastrointestinal diseases
smoking
Breastfeeding and pregnancy and menopause
Taking probiotic and prebiotic supplements, vitamin, minerals, omega-3 and weight-reducing drugs and antibiotics during past one month
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Age
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From 18 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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N/A
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Groups that have been masked
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Individuals with inclusion criteria divided into intervention and control groups using Random allocation software (RAS)
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The intervention and control groups individuals which use oleoylethanolamide and placebo (starch), respectively and main researcher will be blinded in terms of the types of supplements
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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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2016-09-07, 1395/06/17
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Ethics committee reference number
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IR.TB MED.REC.1395.618
Health conditions studied
1
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Description of health condition studied
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obesity
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ICD-10 code
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E66.0
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ICD-10 code description
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Obesity due to excess calories
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 and after supplementation
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Method of measurement
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Real time-PCR
2
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Description
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inflammatory biomarkers (IL-6، TNF-α ، hs-CRP)
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Timepoint
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before and after supplemenation
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Method of measurement
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IL-6 and TNF-α using ELISA, hs-CRP using spectrometry method
3
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Description
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The abundance of Akkermansia muciniphila bacteria in stool samples
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Timepoint
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before and after supplemenation
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Method of measurement
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colony count
4
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Description
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total antioxidant capacity
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Timepoint
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before and after supplemenation
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Method of measurement
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using ELISA method
5
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Description
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lipid profiles and fasting blood glucose
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Timepoint
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before and after supplementation
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Method of measurement
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Using ELISA method
6
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Description
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Dietary intake
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Timepoint
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before and after supplemenation
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Method of measurement
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Three days food record questionnaire
Secondary outcomes
1
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Description
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Anthropometric measurements
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Timepoint
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at baseline and at the end of intervention
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Method of measurement
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Using a stadiometertape and tape in accordance with the standards
2
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Description
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appetite status
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Timepoint
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at baseline and at the end of study
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Method of measurement
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Visual Analouge Scale questionnaire
Intervention groups
1
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Description
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intervention group: daily 2 capsules including 125 mg oleoylethanolamide for eight weeks
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Category
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Prevention
2
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Description
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control group: daily 2 capsule including 125 mg starch for eight weeks
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Category
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Prevention
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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Vice-Chancellor for Research of 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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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there is not more data
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable