Protocol for evaluating the effects of the Reducing Cardiometabolic Diseases Risk dietary pattern in the Chinese population with dyslipidaemia: a single-centre, open-label, dietary intervention study
Fei Ma,
Cheng Cheng,
Li Huang,
Qi Wu,
Guowei Huang,
Huan Liu,
Wen Li,
Jing Yan,
Yongjie Chen,
Yue Du,
Tongtong Li,
Liyang Zhang,
Xukun Chen,
Shanshan Bian,
Zhenshu Li,
Meilin Zhang,
Lichun Cao
Affiliations
Fei Ma
Key Laboratory of Prevention and Control of Major Diseases in the Population, Ministry of Education, Tianjin Medical University, Tianjin, China
Cheng Cheng
Department of Nutrition and Food Science, School of Public Health, Tianjin Medical University, Tianjin, China
Li Huang
Department of Nutrition and Food Science, School of Public Health, Tianjin Medical University, Tianjin, China
Qi Wu
School of Public Health, Tianjin Medical University, Tianjin, China
Guowei Huang
Tianjin Key Laboratory of Environment, Nutrition and Public Health, Tianjin, China
Huan Liu
Department of Nutrition and Food Science, School of Public Health, Tianjin Medical University, Tianjin, China
Wen Li
1 Department of Acupuncture, Moxibustion and Tuina, Seventh People`s Hospital of Shanghai University of Traditional Chinese Medicine, Shanghai, China
Jing Yan
Department of Cardiology, Laboratory of Heart Center, Zhujiang Hospital, Southern Medical University, Guangzhou, China
Yongjie Chen
Tianjin Key Laboratory of Environment, Nutrition and Public Health, Tianjin, China
Yue Du
Tianjin Key Laboratory of Environment, Nutrition and Public Health, Tianjin, China
Tongtong Li
Tianjin Key Laboratory of Ocular Trauma, Tianjin, China
Liyang Zhang
Department of Nutrition and Food Science, School of Public Health, Tianjin Medical University, Tianjin, China
Xukun Chen
Department of Nutrition and Food Science, School of Public Health, Tianjin Medical University, Tianjin, China
Shanshan Bian
Department of Nutrition, The Second Hospital of Tianjin Medical University, Tianjin, China
Zhenshu Li
Department of Nutrition and Food Science, School of Public Health, Tianjin Medical University, Tianjin, China
Meilin Zhang
Department of Nutrition and Food Science, School of Public Health, Tianjin Medical University, Tianjin, China
Lichun Cao
Department of General Practice, Dazhangzhuang Community Medical Service Center, Beichen District, Tianjin, China
Introduction Cardiometabolic disease (CMD) is the leading cause of mortality in China. A healthy diet plays an essential role in the occurrence and development of CMD. Although the Chinese heart-healthy diet is the first diet with cardiovascular benefits, a healthy dietary pattern that fits Chinese food culture that can effectively reduce the risk of CMD has not been found.Methods/design The study is a single-centre, open-label, randomised controlled trial aimed at evaluating the effect of the Reducing Cardiometabolic Diseases Risk (RCMDR) dietary pattern in reducing the risk of CMDs in people with dyslipidaemia and providing a reference basis for constructing a dietary pattern suitable for the prevention of CMDs in the Chinese population. Participants are men and women aged 35–45 years with dyslipidaemia in Tianjin. The target sample size is 100. After the run-in period, the participants will be randomised to the RCMDR dietary pattern intervention group or the general health education control group with a 1:1 ratio. The intervention phases will last 12 weeks, with a dietary intervention of 5 working days per week for participants in the intervention group. The primary outcome variable is the cardiometabolic risk score. The secondary outcome variables are blood lipid, blood pressure, blood glucose, body composition indices, insulin resistance and 10-year risk of cardiovascular diseases.Ethics and dissemination The study complies with the Measures for Ethical Review of Life Sciences and Medical Research Involving Human Beings and the Declaration of Helsinki. Signed informed consent will be obtained from all participants. The study has been approved by the Medical Ethics Committee of the Second Hospital of Tianjin Medical University (approval number: KY2023020). The results from the study will be disseminated through publications in a peer-reviewed journal.Trial registration number Chinese Clinical Trial Registry (ChiCTR2300072472).