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IRCT20170501033747N3 IRCT 2020-04-19 Esfahan University of Medical Sciences Effect of probiotic supplementation on oxidative stress marker Comparison of the effects of probiotic supplementation and omega 3 on oxidative stress marker in healthy children and adolescents exposed to air pollutants: A Randomized, Double-Blind, Placebo-Controlled Trial 2020-09-22 anticipated 100 Complete https://irct.ir/trial/46865 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple randomization sampling will be used. A random number table will be used. The drugs will be labeled with A and B, and each person will randomly be assigned to one 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 subjects expose to air pollution. Intervention 1: The intervention group will consume 1 FamiLact capsules (zist takhmir company, Tehran, Iran) 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 are as the following: • Lactobacillus rhamnosus• Lactobacillus casei• Lactobacillus bulgaricus• Lactobacillus acidophilus• Bifidobacterium breve• Bifidobacterium longum • Streptococcus thermophilus. Intervention 2: Control group will consume 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: heidari.motahar@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 Motahar Heidari-Beni
Hezar Jarib St., Isfahan University of Medical Sciences and Health Services
Isfahan Iran (Islamic Republic of) 8163946711 +98 31 3792 5284 heidari.motahar@gmail.com Esfahan University of Medical Sciences scientific Motahar Heidari-Beni
Hezar Jarib St., Isfahan University of Medical Sciences and Health Services
Isfahan Iran (Islamic Republic of) 8163946711 +98 31 3792 5284 heidari.motahar@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study Healthy subject without any chronic physiological disorders and endocrine diseases Subjects should not take any antioxidant supplements or probiotic products during the study and in the past month Subjects that live in the pollutant areas 10 years 16 years Both Unwillingness to continue study Use of antioxidant supplements other than supplements selected during the study Gastrointestinal problems or sensitivity to the supplement Failure to follow the intervention of the study Z77.110 Contact with and (suspected) exposure to air pollution Prevention Prevention The intervention group will consume 1 FamiLact capsules (zist takhmir company, Tehran, Iran) 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 are as the following: • Lactobacillus rhamnosus• Lactobacillus casei• Lactobacillus bulgaricus• Lactobacillus acidophilus• Bifidobacterium breve• Bifidobacterium longum • Streptococcus thermophilus Control group will consume 1000 mg omega 3 capsule daily for 8 weeks Plasma Malondialdehyde. Timepoint: Before the intervention and after the 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 intervention. Method of measurement: weight (Kg)/ Squared meters. Isfahan University of Medical Sciences Approved 2020-01-05 Isfahan University of Medical Sciences Vice chancellor for research and technology, Isfahan University of Medical Sciences and Health Services, Hezar Jerib Ave. Isfahan Isfehan Iran (Islamic Republic of)