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IRCT20081105001434N12 IRCT 2020-04-21 Esfahan University of Medical Sciences Effect of probiotic supplementation on total antioxidant capacities Comparison of the effects of probiotic supplementation and omega 3 on total antioxidant capacity in children and adolescents exposed to air pollutants: A randomized, double-blind, placebo-controlled trial 2020-09-22 anticipated 100 Complete https://irct.ir/trial/46873 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: A simple randomization method is used. Unit of randomization is individual. A random number table is used. The drugs are labeled A and B, and each person is randomly assigned to each group, Blinding description: Because this is a double-blind study, neither the participants nor the experimenters know who is consuming the drug and who is consuming the placebo. Subjects in both groups will be recruited on different days and will not see each other and will not understand the difference between drugs and the type of supplements that they use. The person who will give the supplements to the participants is not the researcher of the study. Also, all the supplements will be put in the same packaging and with the same label. 3 healthy subject exposed to air pollution. Intervention 1: Intervention group: 1 FamiLact capsule (zist takhmir company, Tehran, Iran) will be consumed daily for 8 weeks . FamiLact ® is a synbiotic (probiotic + prebiotic) formulation and contains high amounts of 9 safe and beneficial bacterial strains plus fructooligosaccharides as prebiotic. Strains and prebiotic used include the following: • Lactobacillus rhamnosus• Lactobacillus casei• Lactobacillus bulgaricus• Lactobacillus acidophilus• Bifidobacterium breve• Bifidobacterium longum • Streptococcus thermophilus. Intervention 2: Control group will receive 1000 mg omega 3 capsule daily for 8 weeks. Yes - There is a plan to make this available What will be shared: Some part of the data, such as information about the main outcome can be shared When: 2021 To whom: Researchers in academic and scientific institutions Conditions: Researchers in academic and scientific institutions when they need the data for meta-analysis study Where to obtain: Send email to roya.kelishadi@gmail.com How to obtain: The applicant can request data and information from the corresponding person after providing a reason for having the data and how to use them Comments:
public Dr. Roya Kelishadi
Hezar Jarib street
Isfahan Iran (Islamic Republic of) 8163946711 +98 31 3792 5281 roya.kelishadi@gmail.com Esfahan University of Medical Sciences scientific Roya Kelishadi, MD
Hezar Jarib street
Isfahan Iran (Islamic Republic of) 8163946711 +98 31 3792 5281 roya.kelishadi@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the studys subjects who live in pollutant areas Healthy subject without any chronic disease, physiological disorders and endocrine disease 10 years 16 years Both use of antioxidant supplements other than supplements selected during the study Gastrointestinal problems Sensitivity to the supplement under the study Taking any antioxidant supplements or probiotic products in the past month Z77.110 Contact with and (suspected) exposure to air pollution Prevention Prevention Intervention group: 1 FamiLact capsule (zist takhmir company, Tehran, Iran) will be consumed daily for 8 weeks . FamiLact ® is a synbiotic (probiotic + prebiotic) formulation and contains high amounts of 9 safe and beneficial bacterial strains plus fructooligosaccharides as prebiotic. Strains and prebiotic used include the following: • Lactobacillus rhamnosus• Lactobacillus casei• Lactobacillus bulgaricus• Lactobacillus acidophilus• Bifidobacterium breve• Bifidobacterium longum • Streptococcus thermophilus Control group will receive 1000 mg omega 3 capsule daily for 8 weeks Total antioxidant capacity. Timepoint: Before intervention and after intervention. Method of measurement: ELISA Kit. Height. Timepoint: before the intervention and after the intervention. Method of measurement: Meter. Weight. Timepoint: before the intervention and after the intervention. Method of measurement: Scale. Waist circumference. Timepoint: before the intervention and after the intervention. Method of measurement: Meter. Body Mass Index. Timepoint: before the intervention and after the interventi. Method of measurement: weight (Kg)/ Squared meters. Esfahan University of Medical Sciences Approved 2020-03-05 Ethics committee Isfahan University of Medical Sciences Vice chancellor for research and technology; No 4 building; Isfahan University of Medical Sciences and Health Services; Hezar Jerib street Isfahan Isfehan Iran (Islamic Republic of)