None listed
Conditions
Interventions
Dietary Supplement : Red Ginseng Extract Powder (KGC05pg) or Placebo Tablets, 500mg/tablet, 2 Tablets/time, Twice a day, Oral administration for 12 weeks
Sponsors
Seoul National University Bundang Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults aged 19 and older 2) Subjects whose fasting blood glucose is 100-125 mg/dL or postprandial blood glucose (2 hour of oral glucose tolerance test) is 140-199 mg/dL and does not take hypoglycemic drugs 3) Subjects who has signed the consent form after being briefed on this stud.
Exclusion criteria
Exclusion criteria: 1) People who took drugs such as oral hypoglycemic agents, injection hypoglycemic drugs, insulin therapy, or health functional foods, or red ginseng for the purpose of blood sugar control treatment before the study 2) People with a history of type 1 diabetes or type 2 diabetes or gestational diabetes (A2 or B1) 3) Subjects whose fasting blood glucose is = 126mg/dL or postprandial blood glucose (2 hour of oral glucose tolerance test) is = 200mg/dL 4) Subjects whose HbA1c is =6.5%. 5) People who has taken diuretics or beta blockers, anticoagulants, and antiplatelet drugs 6) People with a history of coronary artery disease, myocardial infarction, angina, heart failure, ischemic heart disease, arteriosclerosis, arrhythmia, cerebral infarction, cerebral hemorrhage, stroke, lung disease, systemic autoimmune disease, rheumatoid arthritis, thyroid disease, or hypertension 7) People who has taken anti-obesity drugs, lipid-lowering drugs, or health functional foods for the purpose of improving obesity and lipids before the study 8) People who has frequent abnormal bleeding on skin or mucous membranes such as gums, red spots when pressed, purple skin stains, easy bruises, red urine or black feces due to intestinal bleeding, severe nosebleeds, excessive menstruation or postmenopausal vaginal bleeding disorder 9) People whose liver function test (AST, ALT, Total bilirubin, Alkaline phosphatase) value is 2.5 times higher than the normal value 10) People who has a history of renal failure or whose renal function test (Creatinine) value is more than 30% higher than the normal value 11) Subjects with a history of cancer 12) People with body mass index(BMI) = 30 ?/? 13) People who tests positive for hepatitis B 14) Woman who is pregnant or lactating 15) Woman of childbearing age who is not using proper contraception 16) People with a history of alcoholism or substance abuse 17) People who has a hypersensitivity to test products 18) People who is at risk of serious drug interactions due to concomitant medications 19) People who is medically and mentally prohibited from taking test products 20) People who is legally prohibited from participating in study 21) People who participated in other clinical studies within six months before the study 22) People who is judged to be inappropriate for this clinical trial by the researcher
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| postprandial 2 hour glucose (oral glucose tolerance test) | — |
Secondary
| Measure | Time frame |
|---|---|
| oral glucose tolerance test (0, 30, 60, 90, 120 min), Insulin (0, 30, 60, 90, 120 min), HbA1c, HOMA-IR, ß-cell function, Glucose AUC, Insulin AUC, ISI composite, Insulinogenic index, c-peptide, Glucagon, microalbumin/creatinine ratio (RU), Adiponectin, Leptin, glucagon-like peptide 1 (GLP-1), dipeptidyl peptidase 4 (DPP-4);Vital sign, physical examinations and anthropometric measurements, Clinical laboratory tests, Adverse events, Drug Consumption, Modified Morisky Scale | — |
Countries
Korea, Republic of
Contacts
Public ContactHak Chul Jang
Seoul National University Bundang Hospital
Outcome results
None listed