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IRCT20180824040857N2 IRCT 2020-10-18 Artesh University of Medical Sciences Propolis supplementation AND Athletes The effect of propolis supplementation on athletic performance and inflammatory markers and oxidative stress 2020-09-05 anticipated 54 Complete https://irct.ir/trial/51032 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Other, Randomization description: Eligible participants will be randomly assigned, in a ratio of 1:1, to either propolis group or placebo group. Randomization will be stratified according to the participant's age (20-30 vs. 31-40 years). Randomization sequences will be prepared by the study's pharmacist with the use of a random number table, Blinding description: Assignment of participants to the study groups will be concealed from participants and investigators, with the exception of the study pharmacist and care provider, until the end of the study and data analysis. The study pharmacist who will be aware of the assignments will prepared the placebo tablets similar to the propolis tablet in color, odor, taste, shape, size, and weight. Drug containers will be the same in terms of shape, color, odor, size, and weight and will be kept inside numbered, opaque, and sealed envelopes which will be completely impermeable to light. 2 Sports Nutrition. Intervention 1: Intervention group: Participants in the intervention group will receive an identical propolis tablet (450 mg, containing 300 mg Iranian green propolis extract and 150 mg microcrystalline cellulose) three times a day, before breakfast, lunch, and dinner, for 4 weeks. All tablets are prepared by the Reyhan Naghsh Jahan Pharmaceutical Co., Isfahan, Iran. Intervention 2: Control group: Participants in the control group will receive an identical placebo tablet (450 mg, containing 443 mg microcrystalline cellulose and 7 mg edible colors) three times a day, before breakfast, lunch, and dinner, for 4 weeks. All tablets are prepared by the Reyhan Naghsh Jahan Pharmaceutical Co., Isfahan, Iran. 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 Mr. Said Hadi (s.hadinu@yahoo.com). How to obtain: Other researchers in academic institutions can send their request by e-mail to Mr. Said Hadi (s.hadinu@yahoo.com). The data will be sent to them after consulting and approving the research team. Comments:
public Said Hadi
The Islamic Republic of Iran Army University of Medical Sciences, Etemadzadeh street, West Fatemi street, Tehran
Tehran Iran (Islamic Republic of) 1411718541 +98 21 4382 2284 s.hadinu@yahoo.com Artesh University of Medical Sciences scientific Said Hadi
The Islamic Republic of Iran Army University of Medical Sciences, Etemadzadeh street, West Fatemi street, Tehran
Tehran Iran (Islamic Republic of) 1411718541 +98 21 4382 2284 s.hadinu@yahoo.com Artesh University of Medical Sciences Iran (Islamic Republic of) Male gender Exerciser Subjects with Body Mass Index 20 years 40 years Male Female gender Cardiovascular diseases Metabolic diseases Diabetes Musculoskeletal Dysfunction Use of Propolis Supplement Use of Anti-inflammatory Drugs M99 Biomechanical lesions, not elsewhere classified Treatment - Other Placebo Intervention group: Participants in the intervention group will receive an identical propolis tablet (450 mg, containing 300 mg Iranian green propolis extract and 150 mg microcrystalline cellulose) three times a day, before breakfast, lunch, and dinner, for 4 weeks. All tablets are prepared by the Reyhan Naghsh Jahan Pharmaceutical Co., Isfahan, Iran. Control group: Participants in the control group will receive an identical placebo tablet (450 mg, containing 443 mg microcrystalline cellulose and 7 mg edible colors) three times a day, before breakfast, lunch, and dinner, for 4 weeks. All tablets are prepared by the Reyhan Naghsh Jahan Pharmaceutical Co., Isfahan, Iran. Fatigue Index. Timepoint: At the beginning of the study and fourth week of intervention. Method of measurement: RAST test. Anaerobic Power. Timepoint: At the beginning of the study and fourth week of intervention. Method of measurement: RAST test. Aerobic Capacity. Timepoint: At the beginning of the study and fourth week of intervention. Method of measurement: Cooper test. Interleukin-6. Timepoint: At the beginning of the study and fourth week of intervention. Method of measurement: ELISA. Interleukin-10. Timepoint: At the beginning of the study and fourth week of intervention. Method of measurement: ELISA. Catalase activity. Timepoint: At the beginning of the study and fourth week of intervention. Method of measurement: colorimetric method. Superoxide dismutase activity. Timepoint: At the beginning of the study and fourth week of intervention. Method of measurement: colorimetric method. Glutathione concentration. Timepoint: At the beginning of the study and fourth week of intervention. Method of measurement: colorimetric method. Alanine aminotransferase. Timepoint: At the beginning of the study and fourth week of intervention. Method of measurement: Colorimetric method. Aspartate aminotransferase. Timepoint: At the beginning of the study and fourth week of intervention. Method of measurement: Colorimetric method. Vice-Chancellor for Research, The Islamic Republic of Iran Army University of Medical Sciences Approved 2020-09-02 Ethics Committee of the Islamic Republic of Iran Army University of Medical Sciences The Islamic Republic of Iran Army University of Medical Sciences, Etemadzadeh street, West Fatemi street, Tehran Tehran Tehran Iran (Islamic Republic of)