{
  "abstract": "Introduction Dietary intervention is fundamental for the management of type 2 diabetes (T2D), playing a crucial role in stabilising blood glucose levels and improving quality of life. As the major contributor to daily energy intake, the quality of carbohydrates can directly influence the glycaemic stability. Therefore, we aim to explore whether adjusting and optimising the composition of dietary carbohydrates, specifically starch, can provide multiple metabolic benefits for patients with T2D.Methods and analysis This multicentre randomised crossover clinical trial will include 150 participants with T2D. Participants will be assigned to either a conventional diet (CD) following the guidelines for T2D or an optimised carbohydrate diet (OCD) focused on increasing resistant starch intake to 40 g/day and decreasing rapidly digestible starch intake for 12 weeks. This will be followed by a 6-week wash-out period, after which participants will crossover to the alternate diet with equal energy and consistent energy proportion of the three macronutrients for another 12 weeks. The primary outcome is the difference in the change of postprandial glycaemia (changes in the average incremental area under the blood glucose curve (iAUC)) induced by OCD and CD interventions. Secondary outcomes include changes in other glucose and lipid metabolism-related parameters and cognitive function, as well as psychological, behavioural and physiological factors. Exploratory outcomes include changes in the iAUCs for each of the three meals, appetite-related hormone levels, degree of hepatic steatosis, serum cytokines, immune functions and multiomics parameters.Ethics and dissemination The protocol has received approval from the Ethics Committee of Shanghai Sixth People’s Hospital (Approval No. 2025–018; Protocol V.4.1, 20250112) and has been registered with the ClinicalTrials.gov Registry. The findings will be disseminated through peer-reviewed journal publications, conference presentations and media releases.Trial registration number NCT06936657.",
  "authors": [
    {
      "affiliations": [
        "State Key Laboratory of Metabolic Dysregulation & Prevention and Treatment of Esophageal Cancer, Shanghai Key Laboratory of Diabetes Mellitus, Department of Endocrinology and Metabolism, Shanghai Diabetes Institute, Shanghai Clinical Center for Diabetes, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China",
        "Department of Medicine, Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Yuwei LU"
    },
    {
      "affiliations": [
        "State Key Laboratory of Metabolic Dysregulation & Prevention and Treatment of Esophageal Cancer, Shanghai Key Laboratory of Diabetes Mellitus, Department of Endocrinology and Metabolism, Shanghai Diabetes Institute, Shanghai Clinical Center for Diabetes, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China",
        "Department of Medicine, Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Ruiqi Zhang"
    },
    {
      "affiliations": [
        "State Key Laboratory of Metabolic Dysregulation & Prevention and Treatment of Esophageal Cancer, Shanghai Key Laboratory of Diabetes Mellitus, Department of Endocrinology and Metabolism, Shanghai Diabetes Institute, Shanghai Clinical Center for Diabetes, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Jingyi Yang"
    },
    {
      "affiliations": [
        "State Key Laboratory of Metabolic Dysregulation & Prevention and Treatment of Esophageal Cancer, Shanghai Key Laboratory of Diabetes Mellitus, Department of Endocrinology and Metabolism, Shanghai Diabetes Institute, Shanghai Clinical Center for Diabetes, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Dan Liu"
    },
    {
      "affiliations": [
        "State Key Laboratory of Metabolic Dysregulation & Prevention and Treatment of Esophageal Cancer, Shanghai Key Laboratory of Diabetes Mellitus, Department of Endocrinology and Metabolism, Shanghai Diabetes Institute, Shanghai Clinical Center for Diabetes, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China",
        "Department of Medicine, Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Qian Wu"
    },
    {
      "affiliations": [
        "State Key Laboratory of Metabolic Dysregulation & Prevention and Treatment of Esophageal Cancer, Shanghai Key Laboratory of Diabetes Mellitus, Department of Endocrinology and Metabolism, Shanghai Diabetes Institute, Shanghai Clinical Center for Diabetes, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Xiaoxue Long"
    },
    {
      "affiliations": [
        "State Key Laboratory of Metabolic Dysregulation & Prevention and Treatment of Esophageal Cancer, Shanghai Key Laboratory of Diabetes Mellitus, Department of Endocrinology and Metabolism, Shanghai Diabetes Institute, Shanghai Clinical Center for Diabetes, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China",
        "Department of Medicine, Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Di Cheng"
    },
    {
      "affiliations": [
        "Clinical Research Center, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Jingyi Guo"
    },
    {
      "affiliations": [
        "State Key Laboratory of Metabolic Dysregulation & Prevention and Treatment of Esophageal Cancer, Shanghai Key Laboratory of Diabetes Mellitus, Department of Endocrinology and Metabolism, Shanghai Diabetes Institute, Shanghai Clinical Center for Diabetes, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Qian Li"
    },
    {
      "affiliations": [
        "State Key Laboratory of Metabolic Dysregulation & Prevention and Treatment of Esophageal Cancer, Shanghai Key Laboratory of Diabetes Mellitus, Department of Endocrinology and Metabolism, Shanghai Diabetes Institute, Shanghai Clinical Center for Diabetes, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China",
        "Department of Medicine, Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Ying Zhang"
    },
    {
      "affiliations": [
        "State Key Laboratory of Metabolic Dysregulation & Prevention and Treatment of Esophageal Cancer, Shanghai Key Laboratory of Diabetes Mellitus, Department of Endocrinology and Metabolism, Shanghai Diabetes Institute, Shanghai Clinical Center for Diabetes, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China",
        "Department of Medicine, Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Piao Kang"
    },
    {
      "affiliations": [
        "State Key Laboratory of Metabolic Dysregulation & Prevention and Treatment of Esophageal Cancer, Shanghai Key Laboratory of Diabetes Mellitus, Department of Endocrinology and Metabolism, Shanghai Diabetes Institute, Shanghai Clinical Center for Diabetes, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China",
        "Department of Medicine, Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Qinyi Wang"
    },
    {
      "affiliations": [
        "Shanghai Clinical Research and Trial Center, School of Life Science and Technology, ShanghaiTech University, Shanghai, China"
      ],
      "name": "Xiaojing Gao"
    },
    {
      "affiliations": [
        "Shanghai Clinical Research and Trial Center, School of Life Science and Technology, ShanghaiTech University, Shanghai, China",
        "National Facility for Protein Science in Shanghai (NFPSS), Shanghai Advanced Research Institute Chinese Academy of Sciences, Shanghai, Shanghai, China"
      ],
      "name": "Rong Zeng"
    },
    {
      "affiliations": [
        "State Key Laboratory of Metabolic Dysregulation & Prevention and Treatment of Esophageal Cancer, Shanghai Key Laboratory of Diabetes Mellitus, Department of Endocrinology and Metabolism, Shanghai Diabetes Institute, Shanghai Clinical Center for Diabetes, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Mingliang Zhang"
    },
    {
      "affiliations": [
        "State Key Laboratory of Metabolic Dysregulation & Prevention and Treatment of Esophageal Cancer, Shanghai Key Laboratory of Diabetes Mellitus, Department of Endocrinology and Metabolism, Shanghai Diabetes Institute, Shanghai Clinical Center for Diabetes, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Qichen Fang"
    },
    {
      "affiliations": [
        "State Key Laboratory of Metabolic Dysregulation & Prevention and Treatment of Esophageal Cancer, Shanghai Key Laboratory of Diabetes Mellitus, Department of Endocrinology and Metabolism, Shanghai Diabetes Institute, Shanghai Clinical Center for Diabetes, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Weiping Jia"
    },
    {
      "affiliations": [
        "State Key Laboratory of Metabolic Dysregulation & Prevention and Treatment of Esophageal Cancer, Shanghai Key Laboratory of Diabetes Mellitus, Department of Endocrinology and Metabolism, Shanghai Diabetes Institute, Shanghai Clinical Center for Diabetes, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China",
        "Department of Microbiome Dynamics, Leibniz Institute for Natural Product Research and Infection Biology – Leibniz-Hans Knöll Institute, Jena, Germany",
        "Cluster of Excellence Balance of the Microverse, Friedrich Schiller University, Jena, Germany"
      ],
      "name": "Yueqiong Ni"
    },
    {
      "affiliations": [
        "State Key Laboratory of Metabolic Dysregulation & Prevention and Treatment of Esophageal Cancer, Shanghai Key Laboratory of Diabetes Mellitus, Department of Endocrinology and Metabolism, Shanghai Diabetes Institute, Shanghai Clinical Center for Diabetes, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Huating Li"
    }
  ],
  "title": "Intervention effects of optimised carbohydrate diet in patients with type 2 diabetes: study protocol for a randomised controlled crossover trial",
  "uid": "39196e6a-cf94-57ad-88e0-674c9644779e"
}