People involved individuals aged 35 to 65 years, diagnosed with type 2 diabetes. Type 2 diabetes mellitus
Conditions
Interventions
Participants received either a placebo or the test product. The indicated group consumed the product 15 minutes before breakfast for 6 weeks, then stopped for 4 weeks before switching to the other pro
Experimental Dietary Supplement,Placebo Comparator Dietary Supplement
Probiotic (Bifidobacterium animalis TISTR 2591),Placebo
Sponsors
Thailand Institute of Scientific and Technological Research (TISTR)
Eligibility
Sex/Gender
All
Age
35 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male or female between the ages of 35 and 65. 2. Individuals who have type 2 diabetes. 3. Patient whose blood sugar levels are under control while taking metformin. 4. Not taking other diabetes medications or lipid-lowering medications. 5. Have not taken dietary supplements or herbal medications that may lower blood sugar in the four weeks before project participation.
Exclusion criteria
Exclusion criteria: 1. Diabetic women who are pregnant or breastfeeding. 2. People diagnosed with liver disease by a doctor and/or have AST and/or ALT values that are more than three times the upper limit of normal (Renal Function Value (eGFR) 45 mL/min.). 3. Patients suffering from diseases that impair cooperation, such as psychosis, drug addiction, alcoholism, and so on. 4. Those who cannot comply with the procedure and cannot stay until the completion of the study time. 5. Those who oppose or request that they be removed from the research project.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting Blood Glucose (FBG) Levels at Day 0, week 6, week 10, and week 16 Glucose Meter,Fasting insulin levels at Day 0, week 6, week 10, and week 16 Enzyme-Linked Immunosorbent Assay (ELISA),HOMA-IR at Day 0, week 6, week 10, and week 16 Calculation Formula,HOMA-beta (%) at Day 0, week 6, week 10, and week 16 Calculation Formula | — |
Secondary
| Measure | Time frame |
|---|---|
| Immune System Response (IgG, IgM) at Day 0, week 6, week 10, and week 16 Enzyme-Linked Immunosorbent Assay (ELISA),Adipose Tissue Function (Adiponectin) at Day 0, week 6, week 10, and week 16 Enzyme-Linked Immunosorbent Assay (ELISA),Protein Degradation (Cathepsin D enzymatic activity) at Day 0, week 6, week 10, and week 16 Fluorescence intensity ,Inflammation (IL-6) at Day 0, week 6, week 10, and week 16 Enzyme-Linked Immunosorbent Assay (ELISA),Oxidative Stress (MDA) at Day 0, week 6, week 10, and week 16 Thiobarbituric acid reactive substances (TBARS) Assay,Total antioxidant capacity at Day 0, week 6, week 10, and week 16 Trolox equivalent antioxidant capacity (TEAC) assay,Red blood cell glutathione (GSH) levels at Day 0, week 6, week 10, and week 16 Glutathione Assay Kit,Body Composition at Day 0, week 6, week 10, and week 16 Anthropometry,Complete Blood Count at Day 0, week 6, week 10, and week 16 Hematological test,Blood Biochemical Indicators at Day 0, week 6, week 10, and week 16 Hematological test | — |
Countries
Thailand
Contacts
Public ContactSakaewan Ounjaijean
School of Health Sciences Research, Research Institute for Health Sciences, Chiang Mai University, Chiang Mai, Thailand
Outcome results
None listed