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IRCT20231209060310N1 IRCT 2023-12-21 Kermanshah University of Medical Sciences Effect of royal jelly in athletes The effect of royal jelly supplement on athlete performance and gene expressions in endurance-trained men: A double-blind, cross-over, clinical trial 2024-02-20 anticipated 18 Complete https://irct.ir/trial/74241 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Other, Randomization description: The randomization in this study is based on the simple randomization method without stratification. The randomization sequence will be generated with the use of a computer-generated random-number table by the study statistician. Each random sequence will be recorded on a card, and then all cards will be sealed in sequentially numbered opaque envelopes. Envelopes will be opened in their numbered sequence after the enrollment of eligible participants. These participants will be randomly assigned in a 1:1 ratio in a blinded manner to the intervention or control groups, Blinding description: In this trial, random sequences will be placed in sequentially numbered opaque envelopes and remain concealed until enrollment. Eligible participants will be randomly assigned in a 1:1 ratio in a blinded manner to the intervention or control groups. Participants and investigators, except the study statistician, will be concealed from the study‐group assignment until the end of the trial and data analyses. The placebo tablet will be identical in terms of shape, color, size, odor, and weight to the royal jelly tablet. All tablets will be enclosed in similar containers. 2 Sports Nutrition. Intervention 1: Intervention group: Participants will take 500 mg of royal jelly tablets twice daily after breakfast and dinner for 2 weeks. The royal jelly tablets will be prepared by the School of Pharmacy, Mashhad University of Medical Sciences, Iran. Intervention 2: Control group: Participants will take 500 mg of placebo tablets (containing 500 mg of microcrystalline cellulose) twice daily after breakfast and dinner for 2 weeks. The placebo tablets will be prepared by the School of Pharmacy, Mashhad University of Medical Sciences, 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 Dr. Yahya Pasdar. ( e-mail address: yahya.pasdar@kums.ac.ir) How to obtain: Other researchers in academic institutions can send their requests by e-mail to Dr. Yahya Pasdar. The data will be sent to them after consulting and approving the research team. Comments:
public Dr. Yahya Pasdar
Faculty of Nutrition Sciences and Food Industry, next to Farabi Hospital, Isar Square, Kermanshah
Kermanshah Iran (Islamic Republic of) 6719851552 +98 83 3710 2001 yahya.pasdar@kums.ac.ir Kermanshah University of Medical Sciences scientific Dr. Yahya Pasdar
Faculty of Nutrition Sciences and Food Industry, next to Farabi Hospital, Isar Square, Kermanshah
Kermanshah Iran (Islamic Republic of) 6719851552 +98 83 3710 2001 yahya.pasdar@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Having regular endurance activities at least 3 times per week in the last 6 months Providing written informed consent 18 years 44 years Male Use of antioxidant supplements (for example, vitamin E, vitamin C, β-carotene, and selenium), royal jelly, or anti-inflammatory drugs in the last three months History of any acute or chronic respiratory diseases, heart diseases, diabetes mellitus, and metabolic disorders Use of any dietary supplements in the last three months Following specific dietary programs Having musculoskeletal diseases or injuries History of any injuries during training or exercise Allergy to bee products and royal jelly Treatment - Drugs Placebo Intervention group: Participants will take 500 mg of royal jelly tablets twice daily after breakfast and dinner for 2 weeks. The royal jelly tablets will be prepared by the School of Pharmacy, Mashhad University of Medical Sciences, Iran. Control group: Participants will take 500 mg of placebo tablets (containing 500 mg of microcrystalline cellulose) twice daily after breakfast and dinner for 2 weeks. The placebo tablets will be prepared by the School of Pharmacy, Mashhad University of Medical Sciences, Iran. Serum Malondialdehyde. Timepoint: Day 1, 14, 28, and 42 of the study. Method of measurement: Colorimetric method. Serum total antioxidant status. Timepoint: Day 1, 14, 28, and 42 of the study. Method of measurement: Colorimetric method. Serum total oxidative status. Timepoint: Day 1, 14, 28, and 42 of the study. Method of measurement: Colorimetric method. Aerobic Capacity. Timepoint: Day 1, 14, 28, and 42 of the study. Method of measurement: Bruce test. Nrf2 gene. Timepoint: Day 1, 14, 28, and 42 of the study. Method of measurement: PCR. PGC1-α gene. Timepoint: Day 1, 14, 28, and 42 of the study. Method of measurement: PCR. Systolic blood pressure. Timepoint: Day 1, 14, 28, and 42 of the study. Method of measurement: Sphygmomanometer. Diastolic blood pressure. Timepoint: Day 1, 14, 28, and 42 of the study. Method of measurement: Sphygmomanometer. Post-exercise blood pressure. Timepoint: Day 1, 14, 28, and 42 of the study. Method of measurement: Sphygmomanometer. Kermanshah University of Medical Sciences Approved 2023-11-28 Research Ethics Committees of Kermanshah University of Medical Sciences Faculty of Nutrition Sciences and Food Industry, next to Farabi Hospital, Isar Square, Kermanshah Kermanshah Kermanshah Iran (Islamic Republic of)