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.

2024-04
BMJ open 14(4)
- Wu Luo
- Zhiyong Xiao
- Xiao Yang
- Ruiyu Wu
- Jian Li
- Zhen Yu
- Shengxiang Guo
- Beibei Nie
- Dongbo Liu

PubMed: 38684277
DOI: 10.1136/bmjopen-2023-081263

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 120
Population: 120 participants with type 2 diabetes and NAFLD
Methods: Multicentre two-armed parallel randomised controlled trial, CMNT diet with intermittent energy restriction (6 cycles of 5 days meal replacement followed by 10 days regular food) vs usual care
Funding: Unclear

Large Human Trial

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.