An 8-wk, randomized, double-blind, placebo-controlled clinical trial for the antidiabetic effects of hydrolyzed ginseng extract

Abstract

Background: To investigate the antidiabetic effects of hydrolyzed ginseng extract (HGE) for Korean participants in an 8-wk, randomized, double-blinded, placebo-controlled clinical trial.

Methods: Impaired fasting glucose participants [fasting plasma glucose (FPG) ≥ 5.6mM or < 6.9mM] who had not been diagnosed with any disease and met the inclusion criteria were recruited for this study. The 23 participants were randomly divided into either the HGE (n = 12, 960 mg/d) or placebo (n = 11) group. Outcomes included measurements of efficacy (FPG, postprandial glucose, fasting plasma insulin, postprandial insulin, homeostatic model assessment-insulin resistance, and homeostatic model assessment-β) and safety (adverse events, laboratory tests, electrocardiogram, and vital signs).

Results: After 8 wk of HGE supplementation, FPG and postprandial glucose were significantly decreased in the HGE group compared to the placebo group. No clinically significant changes in any safety parameter were observed. Our study revealed that HGE is a potent antidiabetic agent that does not produce noticeable adverse effects.

Conclusion: HGE supplementation may be effective for treating impaired fasting glucose individuals.

Keywords: Panax ginseng; clinical trial; hydrolyzed ginseng extract; impaired fasting glucose; oral glucose tolerance test.

Fig. 1

CONSORT diagram showing the study flow during the 8-wk intervention.

Fig. 2

Blood glucose level and incremental area under the curve (iAUC) obtained during the oral glucose tolerance test prior to and after treatment with hydrolyzed ginseng extract or placebo. All values are presented as mean ± standard deviation. Derived from generalized linear model adjusted for baseline and p-value compared to the placebo group. *p < 0.05

Fig. 3

Blood insulin level and incremental area under the curve (iAUC) obtained during the oral glucose tolerance test prior to and after treatment with hydrolyzed ginseng extract or placebo. All values are presented as mean ± standard deviation. Derived from generalized linear model adjusted for baseline.