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Type 2 diabetes (T2D) represents a serious public health problem. Patients with T2D and non-alcoholic fatty liver disease(NAFLD) demonstrate a poor metabolic profile and increase mortality compared with patients with only NAFLD or T2D. Nutritional intervention is the most basic treatment for T2D. Previous study showed that a Chinese medical nutrition therapy (CMNT) diet, which intermittent use of low-calorie medicinal food, has a glucose-lowering effect in T2D. This study aims to investigate the effect of a Chinese medical nutrition therapy (CMNT) diet accompanied by intermittent energy restriction on reducing liver fat and glycated hemoglobin (HbA1c) in patients with T2D and NAFLD.
Diet composition of CMNT is a multicomponent Chinese medicinal food, which mainly enriched with whole grains and edible medicine and food homologous (MFH) plants such as Rhizoma Dioscoreae, Momordica Grosvenori, Folium Mori, Radix Puerariae, Fructus lycii, Poria cocos that meets the requirements of a food for special medical purpose. The CMNT group was instructed to consumed the provided CMNT diet consisting of 6 cycles of 5 consecutive days followed by 10 days of ad libitum food consumption. Participants received a 917 kcal/day preprepared human CMNT diet (44.75% carbohydrate, 9.1% protein and 46.15% fat) for 5 consecutive days per cycle. CMNT diet is composed of four ready-to-consume prepared foods including composite nutritional rice, solids beverages, meal replacement biscuit and fruit and vegetable gruel mainly from wholegrains and traditional Chinese medicinal food plants. The intervention lasted for 3 months (6 cycles) and follow-up measurements will be performed in all subjects after 3-months from end of the intervention. The glucose-lowering medication use of participants strictly implemented by their physician according to the diabetes medications management protocol. Treatment-as-usual control group continued to be given standard medication and dietary advice by their physician followed guidelines for the prevention and control of T2D in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CMNT diet | Experimental | The CMNT group was instructed to consumed the provided CMNT diet consisting of 6 cycles of 5 consecutive days followed by 10 days of ad libitum food consumption. Participants received a 917 kcal/day preprepared human CMNT diet (44.75% carbohydrate, 9.1% protein and 46.15% fat) for 5 consecutive days per cycle |
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| Usual Care | No Intervention | Dietary recommendations based on the Guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition) as the control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CMNT diet | Other | Hypocaloric CMNT diet plan: A diet plan with intermittent use of enriched traditional-Chinese-medicinal-foods CMNT diet |
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| Measure | Description | Time Frame |
|---|---|---|
| Controlled attenuation parameter (CAP) value by transient elastography | The CAP score, which be measured by FibroScan, will be used to quantify and detect liver fat. CAP < 238 dB/m indicated no hepatic steatosis, 238 ≤ CAP ≤ 259 dB/m denoted mild steatosis, 260 ≤ CAP ≤291 dB/m indicated moderate steatosis, and CAP > 291 dB/m denoted severe steatosis. | 3, 6, 12, 24 months |
| HbA1C | Blood test to measure glucose control | 3, 6, 12, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fatty liver index (FLI) | FLI will also be applied to quantify the degree of steatosis of patients with type 2 diabetes and NAFLD. FLI values < 30 rule out liver steatosis, whereas FLI ≥ 60 confirmed NAFLD with a specificity of 61%. | 3, 6, 12, 24 months |
| Hepatic steatosis index (HSI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luo wu | Contact | 13687333270 | luowubio@163.com | |
| Yang xiao | Contact | 15200877395 | 31884210@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physical Examination Center of Gezhouba central hospital of Sinopharm | Recruiting | Yichang | Hubei | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38684277 | Derived | Luo W, Xiao Z, Yang X, Wu R, Li J, Yu Z, Guo S, Nie B, Liu D. 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 12, 2025 |
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HSI will also be applied to quantify the degree of steatosis of patients with type 2 diabetes and NAFLD. HSI values < 30 excludes NAFLD with a sensitivity of 93.1%, while values > 36 detected NAFLD with a specificity of 92.4%. |
| 3, 6, 12, 24 months |
| Liver stiffness measurement (LSM) value by transient elastography | Liver fibrosis will be assessed by using a non-invasive vibration-controlled transient elastography to estimate LSM. A median LSM ≥ 8.2 kPa was considered indicative of significant fibrosis (≥ F2), whereas LSM ≥ 9.7 kPa was considered indicative of advanced (≥ F3) fibrosis, whereas LSM ≥ 13.6 kPa was considered indicative of cirrhosis (F4). | 3, 6, 12, 24 months |
| Fibrosis-4 index (FIB-4) | The FIB-4 index, a non-invasive measurement, will be used to evaluate the degree of liver fibrosis. The FIB-4 index <1.45 had a negative predictive value of 94.7% to exclude progressive fibrosis, whereas FIB-4 index >3.25 was considered advanced fibrosis or cirrhosis. | 3, 6, 12, 24 months |
| NAFLD fibrosis score (NFS) | Degree of liver fibrosis will also be assessed by NFS.The probability of advanced liver fibrosis was classified into three groups: high NFS (NFS > 0.676), intermediate NFS (NFS: -1.455 to 0.676, or 0.120 to 0.676 if age > 65), or low NFS (NFS < -1.455, or < 0.120 if age > 65) . | 3, 6, 12, 24 months |
| Liver function test | γ-glutamyl transferase (γ-GGT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and ect will be assessed. | 3, 6, 12, 24 months |
| Blood glucose | Fasting plasma glucose (FPG) and postprandial 2-hour plasma glucose (2 h-PG) | 3, 6, 12, 24 months |
| Blood lipid | triglyceride, total cholesterol, low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein-cholesterol (HDL-C) | 3, 6, 12, 24 months |
| Insulin | Glucose homeostasis | 3, 6, 12, 24 months |
| HOMA-IR | Fasting glucose times fasting insulin divided by 22.5 | 3, 6, 12, 24 months |
| IGF-1 | Glucose homeostasis | 3, 6, 12, 24 months |
| Body mass index | Body mass in kilograms divided by height in meters squared. | 3, 6, 12, 24 months |
| waist-to-hip ratio | Waist circumference in centimeter divided by height in centimeter. | 3, 6, 12, 24 months |
| Blood pressure | Systolic blood pressure and diastolic blood pressure. | 3, 6, 12, 24 months |
| Energy intake | 3-day diet record and Food Frequency Questionnaire | 3, 6, 12, 24 months |
| Macronutrient intake | 3-day diet record and Food Frequency Questionnaire | 3, 6, 12, 24 months |
| Sleep quality | Pittsburgh Sleep Quality Index Questionnaire | 3, 6, 12, 24 months |
| Physical activity | International Physical Activity Questionnaire | 3, 6, 12, 24 months |
| Self-reported depressive symptoms | Patient Health Questionnaire 9 | 3, 6, 12, 24 months |
| Anxiety symptoms | Generalized Anxiety Disorder scale | 3, 6, 12, 24 months |
| Social support | Social Support Rate Scale | 3, 6, 12, 24 months |
| Reduction in glucose-lowering medication | Reduction in total dose of glucose-lowering medications | 3, 6, 12, 24 months |
| Fecal microbiota profile | Fecal samples will be collected and will be sequenced. | 3, 6, 12, 24 months |
| Metabolomics | Blood, fecal and urine samples will be collected and metabolites will be analyzed through a metabolomics approach. | 3, 6, 12, 24 months |
| Hunan Shanshui physical examination center | Recruiting | Changsha | Hunan | China |
|
| Jinheyuan Outpatient Department, National Sub-health Intervention Technology Achievement Application Center | Recruiting | Changsha | Hunan | China |
|
| Jul 22, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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