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A clinical study of a diet rich in plant extracts to help improve glycemic health in patients with type 2 diabetes

A clinical study of a diet rich in plant extracts to help improve glycemic health in patients with type 2 diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097329
Enrollment
Unknown
Registered
2025-02-17
Start date
2024-08-27
Completion date
Unknown
Last updated
2025-02-24

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

Conditions

Diabetes

Interventions

Intervention group:Healthy dietary intervention, while drinking 2 bottles of full fat lactose-free milk added with resistant dextrin, mulberry leaf extract and corn whisk daily, morning and evening wi
Control group:Healthy dietary intervention + normal full-fat lactose-free milk: The same dietary intervention was given to the experimental group, while drinking 2 bottles of normal full-fat lactose-f

Sponsors

China Agricultural University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Adults with type 2 diabetes diagnosed in a hospital, aged 18 years or older; (2) There was no clinical evidence of diabetic cardiovascular disease (diabetic cardiomyopathy), diabetic nephropathy, diabetic neuropathy, diabetic eye disease, diabetic lower extremity arterial disease and diabetic foot; hypertension, abnormal lipid metabolism, background diabetic retinopathy and microalbuminuria could be included; (3) After oral hypoglycemic drug treatment, the condition is relatively stable, and there is no need to adjust the hypoglycemic program in the near future; (4) Currently not receiving insulin therapy; (5) The weight has been stable in the past 3 months; (6) Women of childbearing age used contraception during the study period.

Exclusion criteria

Exclusion criteria: (1) Any other type of diabetes; (2) The presence of genetic syndroms or diseases known to affect glucose tolerance (e.g., glucose-6-phosphate dehydrogenase deficiency, polycystic ovary syndrome, etc., except diabetes); (3) There are serious mental system diseases, such as major depression, bipolar disorder, schizophrenia, etc; (4) There are other serious diseases, such as severe liver and kidney dysfunction; (5) Heart surgery within three months; (6) Alcohol or drug abuse in the past year; (7) are taking medications that may affect the primary or secondary outcome of the study; (8) Taking drugs other than hypoglycemic drugs that are known to affect glucose tolerance in the past 30 days (such as thiazide diuretics, glucocorticoids, spironolactones, etc.); (9) Taking a medication known to cause weight gain in the past 30 days; (10) Have taken any weight loss pills in the past 30 days or are on a weight loss program; (11) Taking a drug known to affect the metabolism of the investigational drug; (12) were breastfeeding, pregnant or planning to become pregnant during the study period; (13) are currently working night shifts or have irregular schedules that may preclude intervention strategies; (14) Unable to complete lifestyle intervention due to physical reasons; (15) Food allergy or intolerance; (16) In the last 30 days or currently participating in another clinical trial; (17) Have a definite gastrointestinal disorder, such as irritable bowel syndrome, intestinal obstruction, intestinal perforation, chronic pancreatitis, gastroduodenal ulcer/bleeding, etc; (18) Those who have undergone weight reduction surgery.

Design outcomes

Primary

MeasureTime frame
HAb1C;Fasting blood glucose;Fasting insuline;Glucose drift (blood sugar fluctuation);C-peptide;

Secondary

MeasureTime frame
Total cholesterol;High density lipoprotein, HDL;Blood pressure;Inflammation;Intestinal flora;Uric acid;Low-density lipoprotein cholesterol;Body composition;Hand grip;Triglyceride;Trimethylamine N-oxide;

Countries

China

Contacts

Public ContactGuo Jie

China Agricultural University

guojie@cau.edu.cn+86 186 1331 2725

Outcome results

None listed

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