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)
Abstract 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: overwei...
| Main Authors: | , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2022-12-01
|
| Series: | Food Frontiers |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/fft2.171 |
| _version_ | 1811191306826809344 |
|---|---|
| author | Wenwen Lv Xiyang Tan Xiaochen Chen Tingting Hu Jiayuan Jiang Qiang Li Xiao‐yun Chen Hongsheng Tan Biyun Qian |
| author_facet | Wenwen Lv Xiyang Tan Xiaochen Chen Tingting Hu Jiayuan Jiang Qiang Li Xiao‐yun Chen Hongsheng Tan Biyun Qian |
| author_sort | Wenwen Lv |
| collection | DOAJ |
| description | Abstract 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). |
| first_indexed | 2024-04-11T15:04:25Z |
| format | Article |
| id | doaj.art-d91cce045eb64ca1b7df931fd88bb225 |
| institution | Directory Open Access Journal |
| issn | 2643-8429 |
| language | English |
| last_indexed | 2024-04-11T15:04:25Z |
| publishDate | 2022-12-01 |
| publisher | Wiley |
| record_format | Article |
| series | Food Frontiers |
| spelling | doaj.art-d91cce045eb64ca1b7df931fd88bb2252022-12-22T04:16:51ZengWileyFood Frontiers2643-84292022-12-013455055910.1002/fft2.171D‐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)Wenwen Lv0Xiyang Tan1Xiaochen Chen2Tingting Hu3Jiayuan Jiang4Qiang Li5Xiao‐yun Chen6Hongsheng Tan7Biyun Qian8Hongqiao International Institute of Medicine, Shanghai Tongren Hospital/Clinical Research Institute Shanghai Jiao Tong University School of Medicine Shanghai ChinaDepartment of Rheumatology and Immunology Longhua Hospital Shanghai University of Traditional Chinese Medicine Shanghai ChinaHongqiao International Institute of Medicine, Shanghai Tongren Hospital/Clinical Research Institute Shanghai Jiao Tong University School of Medicine Shanghai ChinaHongqiao International Institute of Medicine, Shanghai Tongren Hospital/Clinical Research Institute Shanghai Jiao Tong University School of Medicine Shanghai ChinaHongqiao International Institute of Medicine, Shanghai Tongren Hospital/Clinical Research Institute Shanghai Jiao Tong University School of Medicine Shanghai ChinaHongqiao International Institute of Medicine, Shanghai Tongren Hospital/Clinical Research Institute Shanghai Jiao Tong University School of Medicine Shanghai ChinaDepartment of Rheumatology and Immunology Longhua Hospital Shanghai University of Traditional Chinese Medicine Shanghai ChinaHongqiao International Institute of Medicine, Shanghai Tongren Hospital/Clinical Research Institute Shanghai Jiao Tong University School of Medicine Shanghai ChinaHongqiao International Institute of Medicine, Shanghai Tongren Hospital/Clinical Research Institute Shanghai Jiao Tong University School of Medicine Shanghai ChinaAbstract 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).https://doi.org/10.1002/fft2.171D‐limoneneMAFLDrandomized controlled trialstudy protocol |
| spellingShingle | Wenwen Lv Xiyang Tan Xiaochen Chen Tingting Hu Jiayuan Jiang Qiang Li Xiao‐yun Chen Hongsheng Tan Biyun Qian 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 D‐limonene MAFLD randomized controlled trial study protocol |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| topic | D‐limonene MAFLD randomized controlled trial study protocol |
| url | https://doi.org/10.1002/fft2.171 |
| work_keys_str_mv | AT wenwenlv dlimoneneforregulatingmetabolismassociatedfattyliverdiseasemafldandanalysisofthetcmconstitutionaprotocolforanexploratoryrandomizeddoubleblindplacebocontrolledtrialdlmafldtcm AT xiyangtan dlimoneneforregulatingmetabolismassociatedfattyliverdiseasemafldandanalysisofthetcmconstitutionaprotocolforanexploratoryrandomizeddoubleblindplacebocontrolledtrialdlmafldtcm AT xiaochenchen dlimoneneforregulatingmetabolismassociatedfattyliverdiseasemafldandanalysisofthetcmconstitutionaprotocolforanexploratoryrandomizeddoubleblindplacebocontrolledtrialdlmafldtcm AT tingtinghu dlimoneneforregulatingmetabolismassociatedfattyliverdiseasemafldandanalysisofthetcmconstitutionaprotocolforanexploratoryrandomizeddoubleblindplacebocontrolledtrialdlmafldtcm AT jiayuanjiang dlimoneneforregulatingmetabolismassociatedfattyliverdiseasemafldandanalysisofthetcmconstitutionaprotocolforanexploratoryrandomizeddoubleblindplacebocontrolledtrialdlmafldtcm AT qiangli dlimoneneforregulatingmetabolismassociatedfattyliverdiseasemafldandanalysisofthetcmconstitutionaprotocolforanexploratoryrandomizeddoubleblindplacebocontrolledtrialdlmafldtcm AT xiaoyunchen dlimoneneforregulatingmetabolismassociatedfattyliverdiseasemafldandanalysisofthetcmconstitutionaprotocolforanexploratoryrandomizeddoubleblindplacebocontrolledtrialdlmafldtcm AT hongshengtan dlimoneneforregulatingmetabolismassociatedfattyliverdiseasemafldandanalysisofthetcmconstitutionaprotocolforanexploratoryrandomizeddoubleblindplacebocontrolledtrialdlmafldtcm AT biyunqian dlimoneneforregulatingmetabolismassociatedfattyliverdiseasemafldandanalysisofthetcmconstitutionaprotocolforanexploratoryrandomizeddoubleblindplacebocontrolledtrialdlmafldtcm |