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

Abstract

Background: 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. Methods: 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. Discussion: 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. Trial registration: Chinese Clinical Trial Registry ChiCTR2400085336. Registered on June 5, 2024.