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 tria...
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2025-01-01
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| Online Access: | https://doi.org/10.1186/s13063-024-08638-0 |
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| author | Gui-yu Li Cui-feng Zhu Zhao-qi Huang Chun-li Piao Jia-jun Yu Li Wang Qiang Zeng Yu-yu Lei Yue Li Xiao-ling Zhu Zhen-tian Zhang Tian-hua Huang Meng-shuang Li Shu-zhong Lin Nai-wen Zhang Fangyingnan Zhang Yong-hua Wang Dan-ping Xu |
| author_facet | Gui-yu Li Cui-feng Zhu Zhao-qi Huang Chun-li Piao Jia-jun Yu Li Wang Qiang Zeng Yu-yu Lei Yue Li Xiao-ling Zhu Zhen-tian Zhang Tian-hua Huang Meng-shuang Li Shu-zhong Lin Nai-wen Zhang Fangyingnan Zhang Yong-hua Wang Dan-ping Xu |
| author_sort | Gui-yu Li |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-2e3e5075829e4a91acfa57a7fb7cecc7 |
| institution | Kabale University |
| issn | 1745-6215 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj-art-2e3e5075829e4a91acfa57a7fb7cecc72025-01-19T12:37:55ZengBMCTrials1745-62152025-01-0126111210.1186/s13063-024-08638-0The 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 trialGui-yu Li0Cui-feng Zhu1Zhao-qi Huang2Chun-li Piao3Jia-jun Yu4Li Wang5Qiang Zeng6Yu-yu Lei7Yue Li8Xiao-ling Zhu9Zhen-tian Zhang10Tian-hua Huang11Meng-shuang Li12Shu-zhong Lin13Nai-wen Zhang14Fangyingnan Zhang15Yong-hua Wang16Dan-ping Xu17Department of Traditional Chinese Medicine, The Eighth Affiliated Hospital, Sun Yat-Sen UniversityDepartment of Clinical Nutrition, Shenzhen Hospital of Southern Medical UniversityCardiovascular Medicine, The Third Affiliated of Guangzhou Medical UniversityDepartment of Endocrinology, Shenzhen Hospital of Guangzhou University of Chinese Medicine (Futian)Department of Traditional Chinese Medicine, The Eighth Affiliated Hospital, Sun Yat-Sen UniversityDepartment of Traditional Chinese Medicine, The Eighth Affiliated Hospital, Sun Yat-Sen UniversityDepartment of Traditional Chinese Medicine, The Eighth Affiliated Hospital, Sun Yat-Sen UniversityDepartment of Traditional Chinese Medicine, Medical College of Qinghai UniversityDepartment of Traditional Chinese Medicine, Medical College of Qinghai UniversityDepartment of Traditional Chinese Medicine, Medical College of Qinghai UniversityDepartment of Clinical Nutrition, Shenzhen Hospital of Southern Medical UniversityDepartment of Clinical Nutrition, Shenzhen Hospital of Southern Medical UniversityCardiovascular Medicine, The Third Affiliated of Guangzhou Medical UniversityDepartment of Endocrinology, Shenzhen Hospital of Guangzhou University of Chinese Medicine (Futian)Department of Endocrinology, Shenzhen Hospital of Guangzhou University of Chinese Medicine (Futian)School of Food Science and Engineering, South China University of TechnologySchool of Food Science and Engineering, South China University of TechnologyDepartment of Traditional Chinese Medicine, The Eighth Affiliated Hospital, Sun Yat-Sen UniversityAbstract 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.https://doi.org/10.1186/s13063-024-08638-0Diacylglycerol oilChronic metabolic syndromeAsymptomatic hyperuricemiaRandomized controlled trial |
| spellingShingle | Gui-yu Li Cui-feng Zhu Zhao-qi Huang Chun-li Piao Jia-jun Yu Li Wang Qiang Zeng Yu-yu Lei Yue Li Xiao-ling Zhu Zhen-tian Zhang Tian-hua Huang Meng-shuang Li Shu-zhong Lin Nai-wen Zhang Fangyingnan Zhang Yong-hua Wang Dan-ping Xu 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 Trials Diacylglycerol oil Chronic metabolic syndrome Asymptomatic hyperuricemia Randomized controlled trial |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Diacylglycerol oil Chronic metabolic syndrome Asymptomatic hyperuricemia Randomized controlled trial |
| url | https://doi.org/10.1186/s13063-024-08638-0 |
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