The effect of royal jelly in oxidative stress, athletic performance, and mitochondrial biogenesis-related gene expression in endurance athletes: study protocol for a double-blind crossover trial

Abstract Background In the field of global health, meeting the energy requirements of athletes has surfaced as an essential concern. This study seeks to evaluate the effectiveness of royal jelly (RJ) in improving exercise performance in endurance-trained men. Methods In this randomized, crossover, d...

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Main Authors: Mahsa Miryan, Vahid Tadibi, Ehsan Sadeghi, Farid Najafi, Amir Saber, Mohammadreza Abbaspour, Yahya Pasdar
Format: Article
Language:English
Published: BMC 2025-02-01
Series:Trials
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Online Access:https://doi.org/10.1186/s13063-025-08780-3
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author Mahsa Miryan
Vahid Tadibi
Ehsan Sadeghi
Farid Najafi
Amir Saber
Mohammadreza Abbaspour
Yahya Pasdar
author_facet Mahsa Miryan
Vahid Tadibi
Ehsan Sadeghi
Farid Najafi
Amir Saber
Mohammadreza Abbaspour
Yahya Pasdar
author_sort Mahsa Miryan
collection DOAJ
description Abstract Background In the field of global health, meeting the energy requirements of athletes has surfaced as an essential concern. This study seeks to evaluate the effectiveness of royal jelly (RJ) in improving exercise performance in endurance-trained men. Methods In this randomized, crossover, double-blind, placebo-controlled study, we will enroll 18 male endurance athletes. Participants will be randomly assigned to one of two conditions: the intervention condition, which will receive royal jelly (RJ) in 500 mg capsules taken orally twice daily for 2 weeks, or the control condition, which will receive a placebo consisting of 500 mg starch capsules taken orally twice daily for the same duration. The study will utilize a 2 × 2 crossover design with a 2-week washout period between treatments. To evaluate aerobic performance, we will determine each participant’s maximal aerobic speed (MAS), followed by a test conducted at 80% of the MAS to measure time to exhaustion. Blood samples (5 cc) will be collected from all participants before and after the treadmill tests to analyze mRNA expressions of Nrf2 and PGC-1α, as well as oxidative stress parameters. Additionally, participants’ dietary intake will be assessed using 3-day food records, and their blood pressure will be monitored before exercise, immediately after, and half an hour post-exercise. Discussion This trial aims to evaluate the effectiveness of RJ as a nutraceutical agent for enhancing endurance athletic performance. We anticipate that the results will provide new insights into the clinical and molecular benefits of RJ. Additionally, these findings will offer valuable data to guide the design and execution of future clinical research involving RJ. Trial registration This study was registered in the Iranian Registry of Clinical Trials (registration No. IRCT20231209060310N1, date: December 21, 2023).
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spelling doaj-art-b8fc2d15ef5146f5bf4931f35477d0352025-08-20T02:54:37ZengBMCTrials1745-62152025-02-0126111510.1186/s13063-025-08780-3The effect of royal jelly in oxidative stress, athletic performance, and mitochondrial biogenesis-related gene expression in endurance athletes: study protocol for a double-blind crossover trialMahsa Miryan0Vahid Tadibi1Ehsan Sadeghi2Farid Najafi3Amir Saber4Mohammadreza Abbaspour5Yahya Pasdar6Student Research Committee, Kermanshah University of Medical SciencesExercise Metabolism and Performance Lab (EMPL), Department of Exercise Physiology, Faculty of Sport Sciences, Razi University, Taq-E BostanDepartment of Food Science and Technology, School of Nutrition Science and Food Technology, Research Center for Environmental Determinants of Health (RCEDH), Health Institute, Kermanshah University of Medical SciencesResearch Center for Environmental Determinacies of Health, School of Public Health, Kermanshah University of Medical SciencesNutritional Sciences Department, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical SciencesTargeted Drug Delivery Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical SciencesNutritional Sciences Department, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical SciencesAbstract Background In the field of global health, meeting the energy requirements of athletes has surfaced as an essential concern. This study seeks to evaluate the effectiveness of royal jelly (RJ) in improving exercise performance in endurance-trained men. Methods In this randomized, crossover, double-blind, placebo-controlled study, we will enroll 18 male endurance athletes. Participants will be randomly assigned to one of two conditions: the intervention condition, which will receive royal jelly (RJ) in 500 mg capsules taken orally twice daily for 2 weeks, or the control condition, which will receive a placebo consisting of 500 mg starch capsules taken orally twice daily for the same duration. The study will utilize a 2 × 2 crossover design with a 2-week washout period between treatments. To evaluate aerobic performance, we will determine each participant’s maximal aerobic speed (MAS), followed by a test conducted at 80% of the MAS to measure time to exhaustion. Blood samples (5 cc) will be collected from all participants before and after the treadmill tests to analyze mRNA expressions of Nrf2 and PGC-1α, as well as oxidative stress parameters. Additionally, participants’ dietary intake will be assessed using 3-day food records, and their blood pressure will be monitored before exercise, immediately after, and half an hour post-exercise. Discussion This trial aims to evaluate the effectiveness of RJ as a nutraceutical agent for enhancing endurance athletic performance. We anticipate that the results will provide new insights into the clinical and molecular benefits of RJ. Additionally, these findings will offer valuable data to guide the design and execution of future clinical research involving RJ. Trial registration This study was registered in the Iranian Registry of Clinical Trials (registration No. IRCT20231209060310N1, date: December 21, 2023).https://doi.org/10.1186/s13063-025-08780-3Royal jellyAthletePerformanceOxidative stressGene expression
spellingShingle Mahsa Miryan
Vahid Tadibi
Ehsan Sadeghi
Farid Najafi
Amir Saber
Mohammadreza Abbaspour
Yahya Pasdar
The effect of royal jelly in oxidative stress, athletic performance, and mitochondrial biogenesis-related gene expression in endurance athletes: study protocol for a double-blind crossover trial
Trials
Royal jelly
Athlete
Performance
Oxidative stress
Gene expression
title The effect of royal jelly in oxidative stress, athletic performance, and mitochondrial biogenesis-related gene expression in endurance athletes: study protocol for a double-blind crossover trial
title_full The effect of royal jelly in oxidative stress, athletic performance, and mitochondrial biogenesis-related gene expression in endurance athletes: study protocol for a double-blind crossover trial
title_fullStr The effect of royal jelly in oxidative stress, athletic performance, and mitochondrial biogenesis-related gene expression in endurance athletes: study protocol for a double-blind crossover trial
title_full_unstemmed The effect of royal jelly in oxidative stress, athletic performance, and mitochondrial biogenesis-related gene expression in endurance athletes: study protocol for a double-blind crossover trial
title_short The effect of royal jelly in oxidative stress, athletic performance, and mitochondrial biogenesis-related gene expression in endurance athletes: study protocol for a double-blind crossover trial
title_sort effect of royal jelly in oxidative stress athletic performance and mitochondrial biogenesis related gene expression in endurance athletes study protocol for a double blind crossover trial
topic Royal jelly
Athlete
Performance
Oxidative stress
Gene expression
url https://doi.org/10.1186/s13063-025-08780-3
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