Prediabetes
Conditions
Interventions
Bifidobacterium longum CCFM1113 group:Bifidobacterium longum CCFM1113
Bifidobacterium longum CCFM1113 compound formula set with Bifidobacterium juvenile CCFM1386 group:Bifidobacterium longum CCFM1113 compound formula set with Bifidobacterium juvenile CCFM1386
Placebo group:Placebo
Sponsors
Shanghai Changzheng Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Abnormal fasting blood glucose (IFG): 6.1< = fasting blood glucose (mmol/L) < 7.0; 2. Impaired glucose tolerance (IGT): 7.8 < = 2 hours of blood glucose (mmol/L) < 11.1 after the test subject took a liquid containing 75 g of glucose for two hours; 3. Abnormal glycosylated hemoglobin (HbA1c): 5.7<=HbA1c (%)<6.5; 4. Meet any of the 1-3 criteria and do not meet the diagnostic criteria for diabetes; 5. Age 18-75 years old, gender is not limited.
Exclusion criteria
Exclusion criteria: 1. Have been diagnosed with diabetes mellitus or have used any hypoglycemic drugs; 2. People who suffer from diseases that cause elevated blood sugar or take drugs that affect blood sugar; 3. Patients with secondary obesity, including diseases such as hypothyroidism or long-term use of drugs that cause obesity; 4. Pregnant or lactating females; 5. Unable, unwilling, or unwilling to comply with study requirements, including lifestyle modifications, return visits, and subject duties; 6. Taking glucocorticoids, antibiotics, prebiotics, probiotics, vitamin supplements, and any other drugs that may interfere with microbiome analysis within 4 weeks prior to enrollment; 7. Allergy or intolerance to the ingredients of the experimental probiotic product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycated Hemoglobin A1c, HbA1c; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting blood glucose;Fecal flora;Continuous blood glucose;Fasting insulin;BMI;Waist-hip ratio;Blood pressure;Blood lipids;Body composition;Liver Elasticity Imaging; | — |
Countries
China
Contacts
Public ContactLi Juan
Shanghai Changzheng Hospital
Outcome results
None listed