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IRCT20091114002709N53 IRCT 2020-02-22 Iran University of Medical Sciences The effect of Synbiotic on aggression The effect of Synbiotic supplementation on the severity of different types of self-reported aggression and anger in healthy adult men. 2021-09-23 anticipated 100 Complete https://irct.ir/trial/44873 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization is done in a randomized, stratified method based on the age and BMI. A randomized list of 100 capsules with codes A and B (randomized blocks of volume 4) is produced by the research consultant and is provided by the researcher, Blinding description: Study subjects and researchers will be blinded to the intervention. Synbiotic and placebo capsules are similar in appearance, odor, weight and packaging and only the code on the package (A or B) is different. 3 Condition 1: aggression. Condition 2: anger. Intervention 1: Intervention group: intake of two daily synbiotic of Familact capsule (produced by Bio-Fermentation Company) for 2 months, each capsule being 500 mg containing 7 species of Lactobacillus casei, Lactobacillus acidophilus , Lactobacillus rhamnosus, Lactobacillus bulgaricus, Bifidobacterium breve, Bifidobacterium longum, Streptococcus thermophilus (109 CFU per capsule) with prebiotic fructooligosaccharide (38 mg). Intervention 2: Control group: Intake of 2 Caps daily containing 500 mg of 75% starch. Yes - There is a plan to make this available What will be shared: Some of the data will be shared, such as information about the main consequences and etc. When: The access period will be 6 months after publication of the results. To whom: The obtained data from the current study will be available only for researchers working in academic and scientific institutions. Conditions: Six months after the publication of the papers from this study, the data obtained will be available to the applicant researchers for further analysis. Where to obtain: Applicants can be contacted with the corresponding author by e-mail or postal address to receive the requested data. Postal address: Nutrition department, School of Health, Iran University of Medical Sciences, Hemmat expressway, Tehran Phone number:0098 21 8862 2755 E-mail: Farzadshidfar@yahoo.com How to obtain: Applicants will be able to access the obtained data from current study by sending an email to the corresponding author, after a maximum of one week. Comments:
public Dr.Farzad Shidfar
School of health, Iran university of medical science, Shahid Hemmat highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8862 2755 Shidfar.f@iums.ac.ir Iran University of Medical Sciences scientific Dr.Farzad Shidfar
School of health, Iran university of medical science, Shahid Hemmat highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8862 2755 Shidfar.f@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Willingness to cooperate 18 to 75 years old Having physical health and no history of cardiovascular, gastrointestinal, metabolic, autoimmune disease, allergies, etc. No history of mental disease such as epilepsy, Bulimia nervosa, Anorexia, etc. No anti-depressant, anti-inflammatory, anti-obesity, anti-diabetic medications, and hormone therapy for at least two months ago. Not taking any omega-3, multivitamin-mineral supplements for at least two months ago. lack of severe family conflicts in 3 months ago. 18 years 75 years Male The dissatisfaction to continue cooperation. Probiotic-containing foods consumption two weeks before and during the study. Antibiotic consumption during the study. Severe family conflicts during the study. consuming Less than 80% of supplements delivered to adolescents. Incidence of any disease during the study. Treatment - Drugs Placebo Intervention group: intake of two daily synbiotic of Familact capsule (produced by Bio-Fermentation Company) for 2 months, each capsule being 500 mg containing 7 species of Lactobacillus casei, Lactobacillus acidophilus , Lactobacillus rhamnosus, Lactobacillus bulgaricus, Bifidobacterium breve, Bifidobacterium longum, Streptococcus thermophilus (109 CFU per capsule) with prebiotic fructooligosaccharide (38 mg). Control group: Intake of 2 Caps daily containing 500 mg of 75% starch. Anger from Aggression Questionnaire. Timepoint: Before the intervention and 2 months after the intervention. Method of measurement: Aggression Questionnaire. Aggression. Timepoint: Before the intervention and 2 months after the intervention. Method of measurement: Aggression Questionnaire. Iran University of Medical Sciences Approved 2019-09-30 Ethics committee of Iran University of Medical Sciences Hemat Express way, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)