prediabetes diagnosis pre-diabetes, Gynostemma pentaphyllum , glucose level, insulin level
Conditions
Interventions
31 volunteers will be randomized to receive GP tea at daily dose of 800 mg/day (400 mg / sachet, twice a day, 30 min before meal) for 12 weeks, consecutively.,31 volunteers will be randomized to recei
Experimental Dietary Supplement,Placebo Comparator No treatment
GP extract tea,placebo tea
Sponsors
The Center of Excellence on Environmental Health and Toxicology (EHT)
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Thai male or female aged between 40-70 years. 2. subjects with prediabetes diagnosis determined by fasting plasma glucose between 100-125 mmol/dL and HbA1C from 5.7% to 6.4%. 3. subjects who agree to continue with current diet and refrain from taking any other dietary supplements during the study. 4. subjects who agree to continue the regularly exercising and normal physical activity level during study period.
Exclusion criteria
Exclusion criteria: 1. Current daily use of any oral hypoglycemic drugs or insulin injection. 2. Elevated liver enzymes or abnormal renal function at baseline. 3. Current daily use of drug-induced glucose alterations (e.g. prednisolone). 4. Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood glucose level pre-dose and post-dose at week 4, 8, 12 and follow up visit at month 3 and 6 Fasting Plasma glucose,Blood glucose level pre-dose and post-dose at week 4, 8, 12 and follow up visit at month 3 and 6 HbA1c,Insulin level pre-dose and post-dose at week 4, 8, 12 and follow up visit at month 3 and 6 Fasting plasma insulin,Insulin secretion and insulin resistance 30, 60, 90 and 120 minutes at pre-dose and post-dose (week 12) and follow up visit at month 3, 6 Oral glucose tolerance test (OGTT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver enzymes pre-dose and post-dose at week 4, 8, 12 and follow up visit at month 3 and 6 ALT, AST,Kidney function pre-dose and post-dose at week 4, 8, 12 and follow up visit at month 3 and 6 S-creatinine, S-BUN,Lipid profiles pre-dose and post-dose at week 4, 8, 12 and follow up visit at month 3 and 6 Triglyceride, Cholesterol, HDL, LDL | — |
Countries
Thailand
Contacts
Public ContactJutamaad Satayavivad
Chulabhorn Research Institute
Outcome results
None listed