A randomized controlled trial on the effects of the Chinese Medical Nutrition Therapy (CMNT) diet on type 2 diabetes: study protocol

Background : Type 2 diabetes (T2D) has become a serious clinical problem since it has affected more than 463 million people. The importance of individual nutrients, foods, and dietary patterns in the prevention and management of type 2 diabetes is highlighted. Chinese Medical Nutrition Therapy (CMNT) is a special dietary intervention pattern featuring traditional Chinese medicine (TCM). The aim of the study is to determine the effect of the CMNT diet on medical nutritional rehabilitation of T2D. The withdrawal rate of anti-diabetic medications will be used to evaluate whether the CMNT diet can improve the blood glucose level and achieve the purpose of nutritional rehabilitation of T2D. Methods : This study is a randomized, controlled, parallel-group study. Seventy T2D patients will be randomly allocated to receive the CMNT diet (n = 35) or to continue their usual diet (as a control, n =35) at a 1:1 ratio for 90 days. Anthropological measures and biochemical assessments, including glycosylated haemoglobin (HbA1c) and plasma lipid profiles, will be performed in from patients at baseline and at the end of the study. The primary outcome is the withdrawal rate of antidiabetic medications. Secondary outcomes are HbA1c, fasting blood glucose (FBG), 2-h postprandial blood glucose (PBG), plasma lipid profiles, blood pressure, body mass index, treatment satisfaction and quality of life. Discussion : Preclinical data showed that the CMNT diet decreased the blood glucose level, improved insulin resistance and promoted β-cell regeneration. However, clinical evidence is lacking. The present study will help in understanding the potential effect of the CMNT diet on the medical nutritional rehabilitation of T2D patients. Consumption of the CMNT diet might decrease the blood glucose level and improve glucose and lipid metabolism. If the CMNT diet demonstrates a significant clinical effect for T2D, it will inform clinical guidelines for the management of T2D in the future. Trial registration : The trial was registered on chictr.org.cn. (Chinese Clinical Trial Registry, ChiCTR) Identifier: ChiCTR2000038036. Registered 9th of September, 2020; retrospectively registered.