Prediabetes and risk factors for type 2 diabetes mellitus, including impaired fasting glucose, impaired glucose tolerance, elevated HbA1c, obesity, abdominal obesity, and dyslipidemia. The study focuses on individuals at risk of developing type 2 diabetes in order to evaluate the preventive effect of Thai probiotic supplements. Type 2 diabetes mellitus, Prediabetes, Probiotics, Dietary supplements, Lacticaseibacillus paracasei, Limosilactobacillus reuteri, and Bifidobacterium animalis
Conditions
Interventions
Participants receive a dietary supplement containing a probiotic combination of Lacticaseibacillus paracasei MSMC39-1, Limosilactobacillus reuteri TF314, and Bifidobacterium animalis TA-1 with resista
(A) Lacticaseibacillus paracasei MSMC39-1, Limosilactobacillus reuteri TF314, and Bifidobacterium animalis TA-1 + Resistant maltodextrin,(B) Lacticaseibacillus paracasei MSMC39-1, Limosilactobacillus
Sponsors
Agricultural Research Development Agency (Public organization)(ARDA)
Siam Agri Supply Co., Ltd.
Eligibility
Sex/Gender
All
Age
20 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age 20 to 60 years 2. Had risk factor for type 2 diabetes mellitus - Fasting plasma glucose 100-125 mg/dL - Hemoglobin A1c 5.7-6.4 % - Impaired glucose tolerance OGTT 2 hour plasma glucose 140-200 mg/dL after 75 g glucose 3. Family history of diabetes mellitus 4. Abdominal obesity or dyslipidemia defined as - Waist circumference greater than 90 cm in men or greater than 80 cm in women - Body mass index 23-25 kg/m2 - Total cholesterol 200-239 mg/dL - Triglycerides 150-199 mg/dL - LDL cholesterol 130-159 mg/dL 5. Not previously diagnosed with diabetes mellitus and not receiving antidiabetic medication such as metformin 6. Willing to participate and signing informed consent
Exclusion criteria
Exclusion criteria: 1. Hypertension with systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg 2. Chronic kidney disease stage 3 or higher or estimated GFR less than 60 mL/min 3. Liver disease with AST/ALT ratio more than 5 times normal or clinical jaundice 4. History of cancer or heart disease 5. Inflammatory bowel disease or other chronic gastrointestinal disorders 6. Thyroid disorders 7. Immunodeficiency or use of immunosuppressive drugs such as after organ transplantation or rheumatoid arthritis 8. Use of medications affecting blood glucose or lipid levels 9. Use of antibiotics, probiotic supplements, synbiotics or laxatives within 4 weeks prior to enrollment 10. Chronic smoking or alcohol abuse 11. Pregnancy, breastfeeding or planning pregnancy during the study period 12. History of allergy to probiotics, maltodextrin, resistant maltodextrin or inulin 13. Refusal to participate or withdraw consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting plasma glucose Baseline and week 12 Change from baseline to week 12 measured from venous blood after 8 to 10 hour fast using an automated clinical chemistry analyzer,Hemoglobin A1c Baseline and week 12 Change from baseline to week 12 measured by standardized HPLC method in the hospital laboratory | — |
Secondary
| Measure | Time frame |
|---|---|
| Lipid profile Baseline and week 12 Change in total cholesterol, LDL cholesterol, HDL cholesterol or triglycerides measured by automated analyzer | — |
Countries
Thailand
Contacts
Public ContactMalai Taweechotipatr
Srinakharinwirot University
Outcome results
None listed