Abstract

BackgroundHemodialysis (HD) is a common renal replacement therapy for patients with renal failure. Cardiovascular and cerebrovascular diseases are known to shorten survival periods and worsen the quality of life of HD patients. Atherosclerosis is a major cause of vascular diseases, and various factors such as abnormality of lipid metabolism and increased macrophage activity, oxidative stress, and endothelial dysfunction are associated with its pathogenesis and progression. Further, endothelial stem cells (ESCs) have been reported to play important roles in endothelial functions. Royal jelly (RJ) affects atherosclerosis- and endothelial function-related factors. The main aim of this trial is to investigate whether oral intake of RJ can maintain endothelial function in HD patients. In addition, the effects of RJ intake on atherosclerosis, ESC count, inflammation, and oxidative stress will be analyzed.MethodsThis will be a multicenter, prospective, double-blind, randomized controlled trial. We will enroll 270 participants at Nagasaki Jin Hospital, Shinzato Clinic Urakami, and Maeda Clinic, Japan. The participants will be randomized into RJ and placebo groups. The trial will be conducted according to the principles of the Declaration of Helsinki, and all participants will be required to provide written informed consent. The RJ group will be treated with 3600 mg/day of RJ for 24 months, and the placebo group will be treated with starch for 24 months. The primary endpoint will be the change in flow-mediated dilation (FMD), a parameter of endothelium function, from the time before treatment initiation to 24 months after treatment initiation. The secondary and other endpoints will be changes in FMD; ESC count; serum levels of vascular endothelial cell growth factor, macrophage colony-stimulating factor, 8-hydroxydeoxyguanosine, and malondialdehyde; the incidence of cardiovascular diseases, cerebrovascular diseases, and stenosis of blood access; and safety.DiscussionThis trial will clarify whether oral intake of RJ can maintain endothelial function and suppress the progression of atherosclerosis in HD patients. In addition, it will clarify the effects of RJ on ESCs, oxidative stress, and angiogenic activity in blood samples.Trial registrationThe Japan Registry of Clinical Trials jRCTs071200031. Registered on 7 December 2020.

Highlights

  • Hemodialysis (HD) is a common renal replacement therapy for patients with renal failure

  • The quality of life (QoL) and survival of HD patients have been improving with developments in dialysis medicine, including dialysis machines, dialyzers, and agents

  • We analyzed temporal changes in vascular function among HD patients because many investigators support the opinion that endothelial dysfunction plays a crucial role in the pathogenesis and development of atherosclerosis, and such pathological conditions are closely associated with vascular diseases [33,34,35]

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Summary

Methods

Study design This clinical trial will be conducted in a multicenter, randomized, double-blind, placebo-controlled setting. There is general agreement that RJ is a safe food, and our study design poses an extremely low risk to patients as the only other invasive intervention will be the collection of a blood sample (20 ml) every 3 months. Considering these aspects, the proposed sample size was calculated according to the expected agreement rates (60%) of patients, which is the object of this trial. A similar analysis will be performed to compare the changes in FMD at 6, 12, and 18 months between the two groups For this analysis, missing data will be used according to the period of RJ administration. Permitted investigators (KO, YM, TM, KM) will have access to these interim results

Discussion
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