{"created":"2023-05-15T16:49:33.686077+00:00","id":27066,"links":{},"metadata":{"_buckets":{"deposit":"7c1b6122-1372-471e-afae-6bab04a3bc52"},"_deposit":{"created_by":6,"id":"27066","owners":[6],"pid":{"revision_id":0,"type":"depid","value":"27066"},"status":"published"},"_oai":{"id":"oai:nagasaki-u.repo.nii.ac.jp:00027066","sets":["8:9"]},"author_link":["120583","120578","120577","120582","120579","120576","120574","120580","120581","120575"],"item_2_biblio_info_6":{"attribute_name":"書誌情報","attribute_value_mlt":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2021-12-20","bibliographicIssueDateType":"Issued"},"bibliographicPageStart":"art. no. 950","bibliographicVolumeNumber":"22","bibliographic_titles":[{"bibliographic_title":"Trials"}]}]},"item_2_description_4":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"Background: Hemodialysis (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.\nMethods: This 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.\nDiscussion: This 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.\nTrial registration: The Japan Registry of Clinical Trials jRCTs071200031.  Registered on 7 December 2020.","subitem_description_type":"Abstract"}]},"item_2_description_63":{"attribute_name":"引用","attribute_value_mlt":[{"subitem_description":"Trials, 22, art. no. 950; 2021","subitem_description_type":"Other"}]},"item_2_publisher_33":{"attribute_name":"出版者","attribute_value_mlt":[{"subitem_publisher":"BioMed Central Ltd"}]},"item_2_relation_12":{"attribute_name":"DOI","attribute_value_mlt":[{"subitem_relation_type":"isIdenticalTo","subitem_relation_type_id":{"subitem_relation_type_id_text":"10.1186/s13063-021-05926-x","subitem_relation_type_select":"DOI"}}]},"item_2_rights_13":{"attribute_name":"権利","attribute_value_mlt":[{"subitem_rights":"© The Author(s). 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data."}]},"item_2_source_id_7":{"attribute_name":"ISSN","attribute_value_mlt":[{"subitem_source_identifier":"1745-6215","subitem_source_identifier_type":"ISSN"}]},"item_2_version_type_16":{"attribute_name":"著者版フラグ","attribute_value_mlt":[{"subitem_version_resource":"http://purl.org/coar/version/c_970fb48d4fbd8a85","subitem_version_type":"VoR"}]},"item_creator":{"attribute_name":"著者","attribute_type":"creator","attribute_value_mlt":[{"creatorNames":[{"creatorName":"Ohba, Kojiro"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Miyata, Yasuyoshi"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Shinzato, Takeaki"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Funakoshi, Satoshi"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Maeda, Kanenori"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Matsuo, Tomohiro"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Mitsunari, Kensuke"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Mochizuki, Yasushi"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Nishino, Tomoya"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Sakai, Hideki"}],"nameIdentifiers":[{}]}]},"item_files":{"attribute_name":"ファイル情報","attribute_type":"file","attribute_value_mlt":[{"accessrole":"open_date","date":[{"dateType":"Available","dateValue":"2022-02-08"}],"displaytype":"detail","filename":"Trials22_950.pdf","filesize":[{"value":"642.1 kB"}],"format":"application/pdf","licensetype":"license_note","mimetype":"application/pdf","url":{"label":"Trials22_950.pdf","url":"https://nagasaki-u.repo.nii.ac.jp/record/27066/files/Trials22_950.pdf"},"version_id":"de7e358a-a2ef-4f57-9df0-e657205dcdea"}]},"item_keyword":{"attribute_name":"キーワード","attribute_value_mlt":[{"subitem_subject":"Royal jelly","subitem_subject_scheme":"Other"},{"subitem_subject":"Atherosclerosis","subitem_subject_scheme":"Other"},{"subitem_subject":"Hemodialysis","subitem_subject_scheme":"Other"},{"subitem_subject":"Endothelial function","subitem_subject_scheme":"Other"},{"subitem_subject":"ESCs","subitem_subject_scheme":"Other"},{"subitem_subject":"Oxidative stress","subitem_subject_scheme":"Other"},{"subitem_subject":"Angiogenic activity","subitem_subject_scheme":"Other"}]},"item_language":{"attribute_name":"言語","attribute_value_mlt":[{"subitem_language":"eng"}]},"item_resource_type":{"attribute_name":"資源タイプ","attribute_value_mlt":[{"resourcetype":"journal article","resourceuri":"http://purl.org/coar/resource_type/c_6501"}]},"item_title":"Effect of oral intake of royal jelly on endothelium function in hemodialysis patients: study protocol for multicenter, double-blind, randomized control trial","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_title":"Effect of oral intake of royal jelly on endothelium function in hemodialysis patients: study protocol for multicenter, double-blind, randomized control trial"}]},"item_type_id":"2","owner":"6","path":["9"],"pubdate":{"attribute_name":"公開日","attribute_value":"2022-02-08"},"publish_date":"2022-02-08","publish_status":"0","recid":"27066","relation_version_is_last":true,"title":["Effect of oral intake of royal jelly on endothelium function in hemodialysis patients: study protocol for multicenter, double-blind, randomized control trial"],"weko_creator_id":"6","weko_shared_id":-1},"updated":"2023-05-15T20:00:59.307189+00:00"}