Efficacy and safety of red ginseng extract powder (KGC05pg) in achieving glycemic control in prediabetic Korean adults A 12-week, single-center, randomized, double-blind, parallel-group, placebo-controlled study

Abstract

Background: This study was conducted to assess the efficacy and safety of Red Ginseng Extract Powder (RGEP) (KGC05pg; Korea Ginseng Corporation, Daejeon, Korea) in achieving glycemic control in prediabetic Korean adults. Methods: The patients of the RGEP group (n = 49) and those of the placebo group (n = 49) were orally given 2 tablets of RGEP and its matching placebo, respectively, at a dose of 500 mg/day twice daily in the morning and the evening within 30 min after meal during a 12-week treatment period. The patients were assessed for glycemic control parameters, such as fasting blood glucose levels, 30-, 60-, 90-, and 120-min blood glucose levels on an oral glucose tolerance test, Hb1Ac levels and glucose area under the curve, insulin resistance parameters, such as homeostasis model assessment of insulin resistance, c-peptide and insulinogenic index, and hormone parameters, such as glucagon, adiponectin and glucagon-like peptide-1. Moreover, the patients were also assessed for time-dependent changes in dipeptidyl peptidase-4 levels. Finally, the patients were also assessed for incidences of treatment-emergent adverse events and serious adverse events. Results: There were significant differences in changes in fasting blood glucose and 30-, 60-, 90-, and 120-min blood glucose levels on an oral glucose tolerance test, Hb1Ac levels, glucose area under the curve, homeostasis model assessment of insulin resistance, c-peptide levels and insulinogenic index, glucagon, adiponectin, and glucagon-like peptide-1 levels at 12 weeks from baseline between the 2 groups (P < .05). There was a significant time-dependent decrease in dipeptidyl peptidase-4 levels in the RGEP group (P = .001). There were no cases of treatment-emergent adverse events and serious adverse events in each treatment arm. Conclusion: RGEP might be effective in achieving glycemic control in prediabetic Korean adults.