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IRCT201607132017N30 IRCT 2016-10-03 Vice-Chancellor for Research of Tabriz University of Medical Sciences Assessment of oleoylethanolamide supplementattion in the prevention and treatment of obesity Assessment of oleoylethanolamide supplementattion in the prevention and treatment of obesity 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 2016-09-22 anticipated 60 Complete https://irct.ir/trial/1641 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Individuals with inclusion criteria divided into intervention and control groups using Random allocation software (RAS), Blinding description: 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. N/A obesity. Intervention 1: intervention group: daily 2 capsules including 125 mg oleoylethanolamide for eight weeks. Intervention 2: control group: daily 2 capsule including 125 mg starch for eight weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is there is not more data
public Laleh Payahoo
Nutrition Faculty, Attar Neyshaburi Street, Golgasht Avenue
Tabriz Iran (Islamic Republic of) 5714775479 +98 41 3335 7580 Llllpayahoo44@gmail.com Faculty of Nutrition, Tabriz University of Medical Science scientific Dr Alireza Ostadrahimi
Nutrition Faculty, Attar Neyshaburi Street, Golgasht Avenue
Tabriz Iran (Islamic Republic of) ۳۳۳۵۹۶۸۰ +98 41 3335 7581 Ostadrahimi@tbzmed.ac.ir Nutrition Faculty, Tabriz University of Medical Sciences Iran (Islamic Republic of) healthy obese subjects in both genders (males and females) Ages between 18 to 59 years body mass index 30-40 kg/m2 18 years 50 years Both 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 E66.0 Obesity due to excess calories Prevention Prevention intervention group: daily 2 capsules including 125 mg oleoylethanolamide for eight weeks control group: daily 2 capsule including 125 mg starch for eight weeks Gene expression of PPAR-α. Timepoint: before and after supplementation. Method of measurement: Real time-PCR. Inflammatory biomarkers (IL-6، TNF-α ، hs-CRP). Timepoint: before and after supplemenation. Method of measurement: IL-6 and TNF-α using ELISA, hs-CRP using spectrometry method. The abundance of Akkermansia muciniphila bacteria in stool samples. Timepoint: before and after supplemenation. Method of measurement: colony count. Total antioxidant capacity. Timepoint: before and after supplemenation. Method of measurement: using ELISA method. Lipid profiles and fasting blood glucose. Timepoint: before and after supplementation. Method of measurement: Using ELISA method. Dietary intake. Timepoint: before and after supplemenation. Method of measurement: Three days food record questionnaire. Anthropometric measurements. Timepoint: at baseline and at the end of intervention. Method of measurement: Using a stadiometertape and tape in accordance with the standards. Appetite status. Timepoint: at baseline and at the end of study. Method of measurement: Visual Analouge Scale questionnaire. Vice-Chancellor for Research of Tabriz University of Medical Sciences Approved 2016-09-07 Ethics committee of Tabriz University of Medical Sciences Faculty of Nutrition and Food sciences, Tabriz University of Medical Sciences Attar Neishabouri Street. Gholgasht street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)