Liver fat as a dietary target by Chinese Medical Nutrition Therapy (CMNT) diet for treating type 2 diabetes with non-alcoholic fatty liver disease: study protocol for a randomised controlled trial

Wu Luo; Zhiyong Xiao; Xiao Yang; Ruiyu Wu; Jian Li; Zhen Yu; Shengxiang Guo; Beibei Nie; Dongbo Liu

doi:10.1136/bmjopen-2023-081263

Liver fat as a dietary target by Chinese Medical Nutrition Therapy (CMNT) diet for treating type 2 diabetes with non-alcoholic fatty liver disease: study protocol for a randomised controlled trial

BMJ Open. 2024 Apr 29;14(4):e081263. doi: 10.1136/bmjopen-2023-081263.

Authors

Wu Luo^{1

2}, Zhiyong Xiao^{2

3}, Xiao Yang^{2

4}, Ruiyu Wu^{2

4}, Jian Li^{4

5}, Zhen Yu², Shengxiang Guo², Beibei Nie², Dongbo Liu^{6

5}

Affiliations

¹ College of Biology, Hunan University, Changsha, Hunan, China.
² Horticulture College, Hunan Agricultural University, Changsha, Hunan, China.
³ The First Affiliated Hospital, Hengyang Medical School, University of South China, Hengyang, Hunan, China.
⁴ Hunan Provincial Engineering Research Center of Medical Nutrition Intervention Technology for Metabolic Diseases, Changsha, Hunan, China.
⁵ Clinical Research Centre, State Key Laboratory of Subhealth Intervention Technology, Changsha, Hunan, China.
⁶ Horticulture College, Hunan Agricultural University, Changsha, Hunan, China liudongbo@hunau.net.

Abstract

Introduction: Type 2 diabetes and non-alcoholic fatty liver disease (NAFLD) often coexist and increase risk for developing liver fibrosis and diabetes complications if no effective measures are taken. Dietary intervention is known to be able to achieve diabetes remission, while evidence regarding the long-term effect on liver fat is limited for comorbidity management of type 2 diabetes and NAFLD. This study aims to investigate the long-term effect of a Chinese Medical Nutrition Therapy (CMNT) diet accompanied by intermittent energy restriction on reducing liver fat and glycated haemoglobin (HbA1c) in patients with type 2 diabetes and NAFLD.

Methods and analysis: This is a multicentre two-armed parallel randomised controlled trial study. 120 participants with type 2 diabetes and NAFLD will be recruited from the physical examination centres of multiple hospitals in China. Participants will be randomly allocated 1:1 to either the CMNT group or the usual care group. The CMNT group will be instructed to consume the provided specific meal replacement Chinese medicinal foods consisting of 6 cycles of 5 consecutive days followed by 10 days of regular food intake. The usual care group will be given standard dietary advice. Primary outcomes are changes in the controlled attenuation parameter value by transient elastography and HbA1c level. Secondary outcomes include differences in anthropometrics, clinical blood markers, questionnaires, gut microbiota and metabolomics. Further follow-up will be performed at 6 months, 1 year and 2 years.

Ethics and dissemination: The study protocol was approved by the Biomedical Research Ethics Committee of Hunan Agricultural University (BRECHAU20200235).The results will be disseminated via relevant peer-reviewed publications and conference presentations.

Trial registration number: NCT05439226.

Keywords: DIABETES & ENDOCRINOLOGY; General diabetes; Lipid disorders.

Publication types

Research Support, Non-U.S. Gov't
Clinical Trial Protocol

MeSH terms

Adult
China
Diabetes Mellitus, Type 2* / diet therapy
Diabetes Mellitus, Type 2* / therapy
Elasticity Imaging Techniques
Female
Glycated Hemoglobin* / metabolism
Humans
Liver / metabolism
Male
Middle Aged
Multicenter Studies as Topic
Non-alcoholic Fatty Liver Disease* / diet therapy
Non-alcoholic Fatty Liver Disease* / therapy
Nutrition Therapy / methods
Randomized Controlled Trials as Topic

Substances

Glycated Hemoglobin

Associated data

ClinicalTrials.gov/NCT05439226