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Research on Total Nutrition Medical Food for Diabetes and Weight Loss

Research on Total Nutrition Medical Food for Diabetes and Weight Loss

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031918
Enrollment
Unknown
Registered
2020-04-14
Start date
2020-05-01
Completion date
Unknown
Last updated
2020-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes ?Weight Loss

Interventions

Diabetes Intervention Group:148g / d for males, 125g / d for females.
Diabetes control group:140g / d for the males and 118g / d for the females.
Weight loss test group:For dinner, 100g of high-protein meal replacement powder (30.3g protein, 11.9g fat, 32.74g carbohydrate) should be substituted for the whole meal

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Diabetes total nutrition medical food 1. Age 30-70 years old; 2. Diagnosis of type 2 diabetes >= 6 months; 3. The condition is stable after lifestyle intervention or drug treatment for more than 3 months (the lifestyle treatment or drug treatment has not adjusted the treatment plan in the past 3 months, and it is expected that the treatment plan will not need to be adjusted in the next month); 4. Fasting blood glucose <= 14mmol / L; 5. Glycated hemoglobin (HbA1c) 7% -9%; 6. Signing informed consent voluntarily. Slimming full nutrition medical food 1. Age 25 to 60 years old, BMI25-40 kg / m2; 2. Voluntarily sign the informed consent.

Exclusion criteria

Exclusion criteria: Diabetes total nutrition medical food Acute metabolic complications occurred within 1.6 months, including those with or without coma, diabetic ketoacidosis with prodromal coma, hyperosmolar hyperglycemia, and lactic acidosis; 2. Those with severe diabetic complications such as diabetic foot, end-stage diabetic nephropathy, cardiovascular disease (except hypertension and hyperlipidemia); 3. People with uncontrollable nausea, vomiting, and inability to eat normally, combined with ulcerative colitis, Crohn's disease, intestinal tuberculosis and other serious gastrointestinal diseases (except functional dyspepsia) or history of gastrointestinal resection ; 4. Patients with systemic lupus erythematosus, hyperthyroidism, Sjogren's syndrome and other autoimmune diseases; 5. Patients with advanced malignant tumors or undergoing anti-tumor therapy such as chemotherapy, radiotherapy, targeting, and immunity; 6. Patients with hepatic insufficiency: alanine aminotransferase (ALT) and aspartate aminotransferase (AST)> 2.5 × upper limit of normal (ULN) or total bilirubin> 1.5 × ULN 7. Patients with renal insufficiency: creatinine> 1.5 × ULN; 8. Those with a history of immunodeficiency, including those who test positive for HIV or have other acquired, congenital immunodeficiency diseases, or have a history of organ transplantation; 9. Those with active replication of hepatitis B virus, or those with active hepatitis C; 10. Those who have taken other total nutrition preparations within 6 weeks; 11. Those who are known to have a history of allergy to the ingredients involved in this study; 12. Those who are using other whole nutrition preparations; 13. People with alcohol dependence (average daily alcohol intake> 30 grams); 14. Those who have a history of drug or psychotropic substance abuse and are unable to quit or have a mental disorder; 15. Those who participated in other clinical trials within 3 months; 16. Those who do not use reliable methods of contraception (including but not limited to hormonacontraception,physical contraception or abstinence), combined with pregnant and lactating women. 17. Use drugs that affect the absorption of the preparation: glucocorticoids, etc .; 18. Those who have undergone surgery within three months Slimming full nutrition medical food 1. Secondary obesity: hypothalamic obesity, hypercortisolism, (endocrine, genetic, metabolic and central nervous system diseases) secondary obesity; 2. Hypothyroidism obesity; 3. Gonadal Hypofunction obesity; 4. Drug obesity, etc.; 5. Pregnancy, pregnancy and breastfeeding, diabetes patients; 6. Patients with severe diseases: heart disease and cerebrovascular disease, liver and kidney dysfunction, Gout, coronary heart disease, malignant tumor, tuberculosis, mental illness, severe gastrointestinal disease, etc.; 7. Exclude those with muscle development (BMI >=28 kg / m2, and male waist-hip ratio 5% weight change 3 months before entering the study; cholesterol-lowering or TG-lowering drugs were taken within 3 months before screening, or plan to use lipid-lowering drugs during the trial period; Surgery; smoking habits changed within 6 months or plan to quit smoking in the next 3 months; participated in other clinical trials within 3 months bef

Design outcomes

Primary

MeasureTime frame
height;weight;Body composition;Blood routine;Urine routine;Liver and kidney function;Lipids;Electrolyte;Glucose tolerance;Glycated albumin;Blood 1,5-Sorbitan;??????(HbA1c);Insulin resistance index;waist;hip;

Countries

China

Contacts

Public ContactXiaoli Huang

Qilu Hospital of Shandong University

724075735@qq.com+86 18560080510

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026