Type 2 diabetes patients with an HbA1c level less than 8%, who are managing their condition through diet or oral hypoglycemic agents, except for alpha-glucosidase inhibitors and incretin-based therapies. Probiotics Glycemic responses Bifidobacterium animalis Lactobacillus johnsonii Limosilactobacillus reuteri subsp. Reuteri Lacticaseibacillus paracasei subsp. Paracasei
Conditions
Interventions
Placebo capsules consisted of maltodextrin, trehalose, and yeast extract, each containing 350 mg per capsule, administered 3 times daily.,Bifidobacterium animalis subsp. lactis TISTR 2591 capsules, wh
Placebo,Probiotic Bifidobacterium animalis subsp. Lactis,Probiotic Bifidobacterium animalis subsp. lactis, Lactobacillus johnsonii, Limosilactobacillus reuteri subsp. Reuteri, and Lacticaseibacillus p
Sponsors
Thailand Institute of Scientific and Technological Research (TISTR)
Eligibility
Sex/Gender
All
Age
30 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Males or females aged 30-60 years 2. Diagnosed with type 2 diabetes 3. HbA1C less than 8% 4. Fasting plasma glucose less than 180 mg/dL 5. Managed through diet or taking oral hypoglycemic agents, except for alpha-glucosidase inhibitors and incretin-based therapies (GLP-1 analogs and DPP-4 inhibitors) 6. No medication changes in the past 3 months 7. Not being pregnant or lactating women 8. Residing in central Thailand for at least 10 years
Exclusion criteria
Exclusion criteria: 1. Using insulin or GLP-1 injections 2. Taking antibacterial medications (e.g., ampicillin, chloramphenicol, tetracycline, erythromycin, gentamicin, streptomycin, clindamycin) within the past month 3. Taking medications that affect glucose metabolism, including steroids, antipsychotics, immunosuppressants, or herbal medicines, within the past month 4. Taking dietary supplements such as fish oil, dietary fiber, chromium, prebiotics, and probiotics within the past month 5. Diagnosed with chronic liver disease, chronic kidney disease, cardiovascular disease, short-bowel syndrome, or other digestion & absorption disorders 6. Abnormal blood coagulation or using anticoagulants 7. Anemic condition or requiring erythropoietin or blood transfusion 8. Currently participating in a lifestyle modification program or following a specific dietary regimen (e.g., ketogenic diet, vegetarian diet) 9. Unstable body weight, defined as 5 kg change within 2 months 10. Uncontrolled blood pressure 11. Smoking and/or drinking alcoholic beverages 12. Allergic to probiotic supplements and placebo components (e.g., maltodextrin, bovine gelatin capsules, trehalose)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incremental area under the curve for blood glucose, insulin, and GLP-1 Baseline and 12 weeks (at the end of intervention) Enzymatic method, electrochemiluminescence immunoassay (ECLIA), and enzyme-linked immunosorbent assay (ELISA), respectively | — |
Secondary
| Measure | Time frame |
|---|---|
| HbA1C and HOMA-IR Baseline, 6 weeks, and 12 weeks (at the end of intervention) Latex agglutination inhibition assay, and Enzymatic method and electrochemiluminescence immunoassay (ECLIA), respectively,Serum IL-1beta, IL-6, IL-10 and TNF-alpha Baseline, 6 weeks, and 12 weeks (at the end of intervention) Enzyme-linked immunosorbent assay (ELISA),Serum total cholesterol, HDL-C, LDL-C, and triglyceride Baseline, 6 weeks, and 12 weeks (at the end of intervention) Enzymatic method, accelerator selective detergent method, enzymatic method, and glycerol phosphate oxidase, respectively | — |
Countries
Thailand
Contacts
Public ContactPennapa Chonpathompikunlert
Thailand Institute of Scientificand Technological Research(TISTR)
Outcome results
None listed