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Note: the numbers in curly brackets in this protocol refer to SPIRIT checklist item numbers. The order of the items has been modified to group similar items (see http://www.equator-network.org/reporting-guidelines/spirit-2013-statement-defining-standard-protocol-items-for-clinical-trials/).
Title {1} | The effects of diacylglycerol edible oil intervention in patients with chronic metabolic syndrome combined with asymptomatic hyperuricemia: study protocol for a multicenter, prospective, double-blind, randomized controlled trial |
Trial registration {2a and 2b} | Chinese Clinical Trial Registry, ChiCTR2400085336. Registered on 5 June 2024. URL: https://www.chictr.org.cn/showproj.html?proj=195688 |
Protocol version {3} | V1.1, 28/12/2022 |
Funding {4} | This study is funded by Guangdong Provincial Key R&D Programme (No. 2022B0202010002). |
Author details {5a} | Gui-yu Li1#, Cui-feng Zhu2#, Zhao-qi Huang3#, Chun-li Piao4#, Jia-jun Yu1, Li Wang1, Qiang Zeng1, Yu-yu Lei5, Yue Li5, Xiao-ling Zhu5, Zhen-tian Zhang2, Tian-hua Huang2, Meng-shuang Li3, Shu-zhong Lin4, Nai-wen Zhang4, Fangyingnan Zhang6, Yong-hua Wang6*, Dan-ping Xu1* 1Department of Traditional Chinese Medicine, The Eighth Affiliated Hospital, Sun Yat-Sen University, Shenzhen 518,033, Guangdong, P. R. China 2Department of Clinical Nutrition, Shenzhen Hospital of Southern Medical University, Shenzhen 518,101, Guangdong, P. R. China 3Cardiovascular Medicine, The Third Affiliated of Guangzhou Medical University, Guangzhou 510,150, Guangdong, P. R. China 4Department of Endocrinology, Shenzhen Hospital of Guangzhou University of Chinese Medicine (Futian), Shenzhen 518,034, Guangdong, P. R. China 5Department of Traditional Chinese Medicine, Medical College of Qinghai University, Xining 810,016, Qinghai, P. R. China 6School of Food Science and Engineering, South China University of Technology, Guangzhou 510,630, Guangdong, China Correspondence: Yong-hua Wang, Dan-ping Xu, email: [email protected], [email protected] #These authors contributed equally to this work. |
Name and contact information for the trial sponsor {5b} | Yong-hua Wang, email: [email protected], Dan-ping Xu, email: [email protected] |
Role of sponsor {5c} | The funders have no role in the management, analysis, and interpretation of data; writing of this report; and the decision to submit the report for publication. |
Introduction
Background and rationale {6a}
Chronic metabolic syndrome is a group of clinical syndromes with abdominal obesity, hyperglycemia/insulin resistance, dyslipidemia, and hypertension, which have a serious impact on body health. It is a combination of metabolic interrelated risk...