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Research on the Development and Utilization Value of Wheat Specially Designed for Diabetics to Stabilize Blood Sugar Levels and Increase Resistance to Starch

Research on the Development and Utilization Value of Wheat Specially Designed for Diabetics to Stabilize Blood Sugar Levels and Increase Resistance to Starch

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107469
Enrollment
Unknown
Registered
2025-08-12
Start date
2025-02-28
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Diabetes

Interventions

Highly resistant starch group:Special wheat flour bread rolls for consumption with high resistant starch
Control group:Regular wheat flour group meal kit

Sponsors

Luoyang Central Hospital Affiliated to Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Meet the 1999 WHO criteria for the diagnosis and treatment of type 2 diabetes; 2. The course of the disease does not exceed 5 years; 3. Body mass index (BMI)>= 24 kg/m^2; 4. Age 18-70 years old; 5. Glycated hemoglobin >=6.5%.

Exclusion criteria

Exclusion criteria: 1. Exclude type 1 diabetes mellitus and special types of diabetes; 2. Patients who have received hypoglycemic drugs such as thiazolidinediones, GIP/GLP-1RA, glycosidase inhibitors or DPP-IV enzyme inhibitors, GKA and other hypoglycemic drugs within 2 weeks before enrollment; 3. Those who use antibiotics or probiotic supplements within 3 months before enrollment or in the study; 4. Acute and chronic digestive system diseases or related drugs (including diarrhea, gastrointestinal infection, cholecystitis, digestive tract obstruction, etc.); gastrectomy, fundoplication, colostomy and other digestive system surgery; 5. Weight fluctuations in the past 3 months>5%; Suffering from diseases that may affect absorption, metabolism and body weight (such as Cushing, hyperthyroidism, hypothyroidism, etc.); 6. Patients with moderate or severe renal impairment (serum creatinine >2mg/dL or 177mmol/L), or abnormal liver function (ALT>2 times the upper limit of normal); moderate and severe chronic obstructive pulmonary disease; patients with severe hypertension, cerebrovascular accidents and tumors; 7. Those with a history of severe drug allergy, asthma, urticaria or other allergies; 8. Pregnant and lactating women; 9. Those who suffer from active infectious diseases such as tuberculosis, hepatitis and AIDS; 10. Patients with severe and acute complications of diabetes, such as: diabetic ketoacidosis, lactic acidosis, diabetic hyperosmolar state, diabetic foot, severe chronic complications, etc.; 11. Subjects receiving controlled medications, including antidepressants, antiserotonin, barbiturates, antipsychotics, central nervous system stimulants; 12. Those who have poor compliance or difficulty in completing treatment; 13. Unable to guarantee sufficient time to participate in this project; 14. Other researchers are not suitable to participate in this project after evaluation.

Design outcomes

Primary

MeasureTime frame
Time spent within target blood glucose range before and after intervention;

Secondary

MeasureTime frame
Glucose tolerance test;Blood lipids;Short-chain fatty acids;Weight;Body composition analysis;

Countries

China

Contacts

Public ContactYanfang Zhang

Luoyang Central Hospital Affiliated to Zhengzhou University

xxzhangin@163.com+86 156 0379 7000

Outcome results

None listed

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