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IRCT20210512051273N1 IRCT 2021-10-23 Tehran University of Medical Sciences Assessment of The Effect of Oral Potassium Nitrate Supplementation on Post-Exercise Delayed Onset Muscle Soreness Indices Assessment of The Effect of Oral Potassium Nitrate Supplementation on Post-Exercise Delayed Onset Muscle Soreness (DOMS) Indices Among Sedentary Individuals Between 18 to 40 Years old: A Double-Blind Randomized Cross-Over Clinical Trial 2021-09-23 anticipated 20 Complete https://irct.ir/trial/58698 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Prevention, Randomization description: The allocation of volunteers will be determined by block randomization method with double, quadruple or sextet variable blocks (one group with symbol A and the other group with symbol B) and using the random number table of Random Allocation Software. Blocking and allocation sequencing for concealment will be done by someone other than the researcher (Allocation Concealment). The allocation ratio of samples will be 1:1 and the volunteers will be divided into two groups receiving potassium nitrate or placebo (Assignment).Then, based on the obtained blocks and order of allocation, one of the two types of capsules with unknown content for the researcher and the volunteer (potassium nitrate or placebo) will be given to group A for and the other capsule will be given to group B for consumption. After the wash-out period, each participant will take a capsule that they did not receive in the first round, Blinding description: The appearance of the intervention and control group capsules is completely the same and only the contents of the capsules are different from each other. All capsules will be given to a third party before the start of the study, and the capsules will be given to the volunteers by a third party before each stage of the study, based on randomization blocks. Only the third party is aware of the contents of the capsules delivered (neither the researcher nor the volunteers will be aware) and the researcher will not be aware of the contents of the capsules given to each candidate until the final analysis of the data. The final analysis of the information will be done by the researcher. N/A Post-Exercise Delayed Onset Muscle Soreness. Intervention 1: Intervention group: The intervention in this study includes the consumption of 1000 mg of potassium nitrate (containing about 600 mg of nitrate and 400 mg of potassium) made by Qatran Shimi Tajhiz Company in the form of capsules, 20 minutes before exercise. Intervention 2: Control group: The control section (placebo) includes the use of capsules containing Stevia made by Roboudian Company with the same appearance as the potassium nitrate capsule, which will be consumed similar to the intervention section (20 minutes before exercise). Yes - There is a plan to make this available What will be shared: The present study has been registered as a proposal for the thesis of sports medicine residency. The dissertation resulting from this proposal including participants' data (all data), study protocol, statistical analysis and study report (including all variables) will be provided to Tehran University of Medical Sciences and Sports Medicine Department. It should be noted that after the dissertation is approved, an article containing all the items mentioned will be published in one of the journals relevant to the research topic. It should be noted that access to detailed data that were not published in the final report or article, requires communication with the researcher in charge of the study. When: The present study started on 23/9/2021 and for all stages until the submission of the dissertation, a period of two years is predicted. The data obtained from this research will be presented in the form of an article after the dissertation is approved (end of 2 years) for publication. Access to the detailed data that were not published in the final report or article will be possible after the publication of the article through direct contact with the researcher in charge of the study. To whom: The data obtained from this research will be available to all applicants and there will be no restrictions. Conditions: There is no restriction on the use, dissemination or processing of the data in this study, provided that correspondence is sent via email or other means to the researcher in charge of the study and the necessary permission is issued by the researcher in charge. Where to obtain: To access the information in this study, the applicant can contact the researcher in charge of this study by e-mail or telephone. How to obtain: The license to use the information is issued to the applicant as soon as possible after receiving and viewing the e-mail or making a phone call, and then the requested information will immediately sent to the applicant via e-mail. Comments:
public Mohammad Mahdi Tavana
Department of Sports Medicine, Imam Khomeini Hospital Complex, Gharib Street, Keshavarz Boulevard
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 21 2281 8672 tavana.md@yahoo.com Tehran University of Medical Sciences scientific Farzin Halabchi
Department of Sports Medicine, Imam Khomeini Hospital Complex, Gharib Street, Keshavarz Boulevard
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 21 6658 1637 fhalabchi@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age between 18 to 40 years Consent to enter the study Not having physical or mental illness which increase the risk of impaired study progress Sedentary lifestyle (less than 3 days of sports activity for 30 minutes a week in the last 3 months) No addiction to drugs, narcotics and tobacco No pregnancy and breastfeeding No pain or injury in the biceps brachii muscle that will be studied 18 years 40 years Both Taking different types of drugs during the week before the study Taking tonics and sports supplements during 1 month before History of musculoskeletal injury during the last three months Using foods containing more than 50 mg of nitrate per 100 g of food within 24 hours before the research protocol M63 Disorders of muscle in diseases classified elsewhere Prevention Placebo Intervention group: The intervention in this study includes the consumption of 1000 mg of potassium nitrate (containing about 600 mg of nitrate and 400 mg of potassium) made by Qatran Shimi Tajhiz Company in the form of capsules, 20 minutes before exercise. Control group: The control section (placebo) includes the use of capsules containing Stevia made by Roboudian Company with the same appearance as the potassium nitrate capsule, which will be consumed similar to the intervention section (20 minutes before exercise). Biceps Brachii Muscle Tenderness. Timepoint: Before Exercise, Days 2 and 4 Post-Exercise. Method of measurement: Placing a wooden ball with a diameter of 3 cm, 3 cm above the crease of the elbow and place a sphygmomanometer on it and inflate the cuff up to 250 mm Hg and record the amount of pain on graded paper (Visual Analogue Scale). Strength of Biceps Brachii Muscle. Timepoint: Before Exercise, Days 2 and 4 Post-Exercise. Method of measurement: Measuring muscle force with a dynamometer. Elbow Passive and Active Range of Motion. Timepoint: Before Exercise, Days 2 and 4 Post-Exercise. Method of measurement: Measuring angles with goniometer. Vice chancellor for research and technology, Tehran University of Medical Sciences Approved 2021-09-01 Imam Khomeini Hospital Complex - Tehran University of Medical Sciences (Research Ethics Committee) Deputy of Research and Technology, Imam Khomeini Hospital Complex, Gharib Street, Keshavarz Boulevard Tehran Tehran Iran (Islamic Republic of)