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IRCT20180201038585N4 IRCT 2019-07-11 Bagheiat-allah University of Medical Sciences The effect of probiotic supplementation on physical performance , sleep quality and mood Comparison of Probiotics supplementation and placebo Effect on Physical Performance, Mood and Sleep Quality in Military Students 2019-03-05 anticipated 60 Complete https://irct.ir/trial/33215 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, Randomization description: Randomization to group intervention and control A stratified randomized permuted block (with block size 4) will generated by an independent bio-statistician. Subjects will stratified according to gender and age. Random assignment will done by the use of table of random numbers. The enrolling participants, and assigning participants to the groups will carried out by a trained nutritionist. Researchers will not informed about randomization process until completion of data analyses (concealme, Blinding description: All probiotics and its placebo powders will be provided by Zisttakhmir company in pre-packed boxes and will be numbered for each patient according to the randomization sequence. probiotic and its placebos will be in the same form of package and the patients and researcher will not aware of the content of the pack until the end of the trial. 3 physical performance, mood and sleep quality. Intervention 1: Probiotics, one gram, zist takhmir company. Intervention 2: Placebo. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No decision has been made yet
public Karim Parastouei
Sheykh bahaei Ave , Molasadra Ave
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8248 2341 parastoei@bmsu.ac.ir Bagheiat-allah University of Medical Sciences scientific karim parastouei
Sheykh Bahaei Ave, Molasadra Ave
tehran Iran (Islamic Republic of) 1435916471 +98 21 8248 3264 parastouei@bmsu.ac.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Male students 18 to 26 years old Students who have no visible physical illness or injury The whole of the students will be from one period and will be under the same military training and will benefit from the same nutrition. 18 years 26 years Male Students who are not satisfied with the use of probiotics or placebo Students injured during the course of military exercises Students diagnosed as having probiotic susceptibility Students who are physically unable to work Treatment - Drugs Placebo Probiotics, one gram, zist takhmir company Placebo Physical performance. Timepoint: One day Before and one day after Supplementation. Method of measurement: Sport test (runing 1600 m , runing 4×9m , Barfix , sit-ups) and cooper test. Mood. Timepoint: One day Before and one day after Supplementation. Method of measurement: Brums questionnaires. Sleep quality. Timepoint: One day Before and one day after Supplementation. Method of measurement: PSQI questionnaires. Bagheiat-allah University of Medical Sciences Approved 2019-01-21 Ethics committee of bahgeyatlah University of Medical Sciences Sheykh bahaei Ave, Molasadra Ave Tehran Tehran Iran (Islamic Republic of)