Li Gui-Yu, Zhu Cui-Feng, Huang Zhao-Qi, Piao Chun-Li, Yu Jia-Jun, Wang Li, Zeng Qiang, Lei Yu-Yu, Li Yue, Zhu Xiao-Ling, Zhang Zhen-Tian, Huang Tian-Hua, Li Meng-Shuang, Lin Shu-Zhong, Zhang Nai-Wen, Zhang Fangyingnan, Wang Yong-Hua, Xu Dan-Ping
Department of Traditional Chinese Medicine, The Eighth Affiliated Hospital, Sun Yat-Sen University, Shenzhen, 518033, Guangdong, P. R. China.
Department of Clinical Nutrition, Shenzhen Hospital of Southern Medical University, Shenzhen, 518101, Guangdong, P. R. China.
Trials. 2025 Jan 13;26(1):16. doi: 10.1186/s13063-024-08638-0.
The aim of this study is to evaluate the efficacy and safety of diacylglycerol (DAG) edible oil intervention in patients with chronic metabolic syndrome complicated by asymptomatic hyperuricemia through a multicenter, prospective, double-blind, randomized controlled clinical trial.
A multicenter, double-blind, and randomized controlled trial involving 176 patients was designed. All patients with chronic metabolic syndrome complicated by asymptomatic hyperuricemia who meet inclusion and exclusion criteria will be included in the study and will be randomized to either group A or group B. Group A will receive DAG-rich oil (≥ 80%) and group B will receive conventional cooking oil (triacylglycerol (TAG)-rich oil) for 12 weeks. Serum uric acid level is the primary outcome. Fasting blood glucose, 2 h postprandial blood glucose, fasting insulin, glycated hemoglobin, lipid profile, and average carotid intima-media thickness will be evaluated as the secondary outcomes. Blood routine, urine routine, liver enzymes, and electrocardiogram will be tested to assess the safety. The sample size for each group was calculated to be 88 cases.
We will evaluate the efficacy and safety of DAG oil compared with conventional TAG oil in patients with chronic metabolic syndrome with asymptomatic hyperuricemia. The dietary oil with superior efficacy and better safety will be recommended for reference use.
Chinese Clinical Trial Registry ChiCTR2400085336. Registered on June 5, 2024.
本研究旨在通过一项多中心、前瞻性、双盲、随机对照临床试验，评估二酰甘油（DAG）食用油干预对慢性代谢综合征合并无症状高尿酸血症患者的疗效和安全性。
设计了一项涉及176例患者的多中心、双盲、随机对照试验。所有符合纳入和排除标准的慢性代谢综合征合并无症状高尿酸血症患者将被纳入研究，并随机分为A组或B组。A组将接受富含二酰甘油（≥80%）的食用油，B组将接受传统食用油（富含三酰甘油（TAG）的食用油），为期12周。血清尿酸水平是主要结局。空腹血糖、餐后2小时血糖、空腹胰岛素、糖化血红蛋白、血脂谱和平均颈动脉内膜中层厚度将作为次要结局进行评估。将检测血常规、尿常规、肝酶和心电图以评估安全性。每组样本量计算为88例。
我们将评估DAG食用油与传统TAG食用油相比，对慢性代谢综合征合并无症状高尿酸血症患者的疗效和安全性。将推荐疗效更佳且安全性更好的食用油以供参考使用。
中国临床试验注册中心ChiCTR2400085336。于2024年6月5日注册。
