D-Limonene for regulating metabolism-associated fatty liver disease (MAFLD) and analysis of the TCM constitution: A protocol for an exploratory, randomized, double-blind, placebo-controlled trial (DL-MAFLD-TCM)
The protocol describes the first study evaluating the treatment of metabolism-associated fatty liver disease (MAFLD). MAFLD, formerly known as nonalcoholic fatty liver disease, was renamed by an internationally renowned liver disease expert group in 2020. MAFLD contains three types: overweight/obesity (A type), type 2 diabetes mellitus (B type), or evidence of metabolic dysregulation (C type). There is a lack of effective therapeutic drugs. We found that D-limonene, a food additive in China, has potential activity on the A type of MAFLD through animal studies. Then, we designed an exploratory, single-center, double-blind, placebo-controlled, randomized clinical trial for the evaluation of limonene capsules (marketed product in China) on regulating A type of MAFLD and analysis of the TCM constitution (DLMAFLD-TCM). A total of 60 patients with A type of MAFLD will be randomly assigned to a treatment arm with (n = 30) or without (n = 30) Food Frontiers for Review Only limonene (placebo) for 12 weeks. The primary end point will be assessed at two end points combined for A type: changes in the controlled attenuation parameter and body mass index at baseline and 12 weeks after administration. The study procedures and informed consent form were approved by the hospital. We detail the protocol and the statistical analysis plan of the trial prior to study completion, which is for further study. This trial is registered in the Chinese Clinical Trial Registry (ChiCTR2000035888).
基金:
Shanghai Shen Kang Hospital Development
Center funding, Grant/Award Number:
SHDC2020CR4095; Startup Fund for
Youngman Research at SJTU, Grant/Award
Number: 20X100040015
第一作者机构:[1]Shanghai Jiao Tong Univ, Shanghai Tongren Hosp, Hongqiao Int Inst Med, Clin Res Inst,Sch Med, Shanghai 200025, Peoples R China
共同第一作者:
通讯作者:
通讯机构:[1]Shanghai Jiao Tong Univ, Shanghai Tongren Hosp, Hongqiao Int Inst Med, Clin Res Inst,Sch Med, Shanghai 200025, Peoples R China[2]Shanghai Univ Tradit Chinese Med, Dept Rheumatol & Immunol, Longhua Hosp, Shanghai 200032, Peoples R China[*1]Department of Rheumatology and Immunology, Longhua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China.[*2]Hongqiao International Institute ofMedicine, Shanghai Tongren Hospital/Clinical Research Institute, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China.
推荐引用方式(GB/T 7714):
Lv Wenwen,Tan Xiyang,Chen Xiaochen,et al.D-Limonene for regulating metabolism-associated fatty liver disease (MAFLD) and analysis of the TCM constitution: A protocol for an exploratory, randomized, double-blind, placebo-controlled trial (DL-MAFLD-TCM)[J].FOOD FRONTIERS.2022,3(4):550-559.doi:10.1002/fft2.171.
APA:
Lv, Wenwen,Tan, Xiyang,Chen, Xiaochen,Hu, Tingting,Jiang, Jiayuan...&Qian, Biyun.(2022).D-Limonene for regulating metabolism-associated fatty liver disease (MAFLD) and analysis of the TCM constitution: A protocol for an exploratory, randomized, double-blind, placebo-controlled trial (DL-MAFLD-TCM).FOOD FRONTIERS,3,(4)
MLA:
Lv, Wenwen,et al."D-Limonene for regulating metabolism-associated fatty liver disease (MAFLD) and analysis of the TCM constitution: A protocol for an exploratory, randomized, double-blind, placebo-controlled trial (DL-MAFLD-TCM)".FOOD FRONTIERS 3..4(2022):550-559