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IRCT20181014041336N1 IRCT 2019-01-15 Mashhad University of Medical Sciences The effect of pragmatic rations on the performance of military personnel with intense activity Design and evaluation of humanitarian ration formulations in crisis with emphasis on functional capacity and oxidative stress levels. 2018-12-21 anticipated 45 Complete https://irct.ir/trial/34532 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: Our goal is to formulate a diet with military application, treatment and use in crisis and review it in the form of a clinical trial, Randomization description: Samples were randomly selected using randomized block method and RAS software was divided into 3 groups of 15, the first group received intervention, receiving diet with functional and extractive compounds, and the second and third groups of control, respectively, receiving the ration of pragmatic and usual diet Used in operational areas with the same amount of calories, Blinding description: Stratified block randomization. N/A Military personnel in operational maneuvers. Intervention 1: Intervention group: Receive Compact Food ration with pragmatic and beneficial compounds for 10 days. Intervention 2: Control group: Receive Compact Food ration without pragmatic and beneficial compounds for 10 days. Intervention 3: Control group: traditional rations used in operational areas for 10 days. Yes - There is a plan to make this available What will be shared: The non-identifiable individual participant data collected in this study will be shared. Also, The protocol, results, and statistical analysis of the current study will be published in the relevant articles. When: The non-identifiable individual participant data will become available after the publication of the relevant articles. To whom: The non-identifiable individual participant data will become available to other researchers in academic institutions. Conditions: The non-identifiable individual participant data can only be used for research. Where to obtain: The non-identifiable individual participant data will be obtainable by sending an e-mail to Dr. Abdul Reza norouzy. ( Norouzya@mums.ac.ir) How to obtain: Other researchers in academic institutions can send their request to Dr. Abdul Reza Norouzy. Comments:
public Dr. Abdolreza Norouzi
Faculty of Medicine, Mashhad University of Medical Sciences, Paradise Daneshgah, Azadi Square
Mashhad Iran (Islamic Republic of) 91779-48564 +98 51 3882 7033 Norouzya@mums.ac.ir Mashhad University of Medical Sciences scientific Dr Abdolreza Norouzi
Faculty of Medicine, Mashhad University of Medical Sciences, Paradise Daneshgah, Azadi Square
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3882 7033 Norouzya@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Military personnel are maneuvering operations Age range 18-50 years Do not use antioxidant and herbal supplements at least 1 month before starting the study Willingness to cooperate and sign a conscientious consent form after full knowledge of the goals and method of the study 18 years 50 years Male Special Diet for at least 6 months History of any allergies and allergies to certain compounds smoking Use of any antioxidant and anti-inflammatory nutritional supplement during the study Unwillingness to participate in the study or continue cooperation Other Other Other Intervention group: Receive Compact Food ration with pragmatic and beneficial compounds for 10 days Control group: Receive Compact Food ration without pragmatic and beneficial compounds for 10 days Control group: traditional rations used in operational areas for 10 days Total antioxidant capacity. Timepoint: At baseline and after 10 day of intervention. Method of measurement: blood sample. Malondialdehyde. Timepoint: At baseline and after 10 day of intervention. Method of measurement: Spectrophotometry. High-sensitivity C-reactive protein. Timepoint: At baseline and after 10 day of intervention. Method of measurement: Immunoturbidimetry. Maximum rate of oxygen consumption (vo2max). Timepoint: At baseline and after 10 day of intervention. Method of measurement: step test. Mashhad University of Medical Sciences Approved 2018-10-24 Ethics Committee of Mashhad University of Medical Sciences Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)