Glucose Tolerance Test and Pharmacokinetic Study of Kaempferia parviflora Extract in Healthy Subjects

Abstract

Kaempferia parviflora Wall. ex Baker (KP), Krachaidam in Thai or Thai ginseng, is a herbal medicine that has many potential pharmacological effects. The effect of KP extract on blood glucose level in rodent was reported. This study focused on the oral glucose tolerance test and pharmacokinetic study in healthy volunteers administered with KP extract (90 and 180 mg/day, placebo). The oral glucose tolerance tests were performed at baselines and 28-days of administration. The pharmacokinetics were determined after a single dose administration of the tested products using 3,5,7,3′,4′-pentamethoxyflavone (PMF) and 5,7,4′-trimethoxylflavone (TMF) as markers. The results showed that glucose metabolism via oral glucose tolerance test was not affected by KP extract. Blood glucose levels of volunteers at 120 min after glucose loading were able to be returned to initial levels in placebo, KP 90 mg/day, and KP 180 mg/day groups both at baseline and 28-days of administration. The results of the pharmacokinetic study revealed that only TMF and PMF, but not 5,7-dimethoxyflavone (DMF) levels could be detected in human blood. The given doses of KP extract at 90 and 180 mg/day showed a linear dose-relationship of blood PMF concentration whereas blood TMF was detected only at high given dose (180 mg/day). The half-lives of PMF and TMF were 2–3 h. The maximum concentration (Cmax), area under the curve of blood concentration and time (AUC), and time to maximum concentration (Tmax) values of PMF and TMF estimated for the 180 mg/day dose were 71.2 ± 11.3, 63.0 ± 18.0 ng/mL; 291.9 ± 48.2, 412.2 ± 203.7 ng∙h/mL; and 4.02 ± 0.37, 6.03 ± 0.96 h, respectively. PMF was quickly eliminated with higher Ke and Cl than TMF at the dose of 180 mg/day of KP extract. In conclusion, the results demonstrated that KP extract had no effect on the glucose tolerance test. In addition, this is the first demonstration of the pharmacokinetic parameters of methoxyflavones of KP extract in healthy volunteers. The data suggest the safety of the KP extract and will be of benefit for further clinical trials using KP extract as food and sport supplements as well as a drug in health product development.

Preliminary studies of Volten VR4® Kaempferia parviflora herb extracts on blood glucose levels in human type-2 diabetes mellitus and its mineral element analysis

“…Furthermore, as shown in table 3, the consumption of capsules from the first day for each participant significantly dropped after taking 400 mg capsules. The results that show the reduction of blood glucose using KP was consistent with results that have been reported by Azuma and Sripanidkulchai [17,18].…”

Medicinal importance of Kaempferia galanga L. (Zingiberaceae): A comprehensive review

“…The ethanol extract of K. galanga found to be beneficial to combat an obesity-induced dermatopathy system in Tsumura Suzuki obese diabetic (TSOD) mice as a model of obesity. It was shown a decrease in the body weight of rats and the thickness of the subcutaneous fat layer more than the polymethoxiflavonoid fraction, which was utilized as a dietary supplement in controlling skin disorders due to obesity (61).…”

Pharmacokinetics and Metabolites of 12 Bioactive Polymethoxyflavones in Rat Plasma

“…A subsequent study by Sripanidkulchai et al 18 reported the oral pharmacokinetics of compound 9 in rats administered Kaempferia parviflora extract, of which compound 9 was a major component. Recently, a clinical trial by the same group 19 further evaluated the oral pharmacokinetics and metabolites of compound 9 after administration of K. parviflora extract. Despite their extensive work and positive findings, K. parviflora extract contains a large number of constituents in addition to compound 9, and the pharmacokinetics of compound 9 were likely to be influenced by other components because of potential competition or inhibition between components during the pharmacokinetic process (e.g., absorption and metabolism).…”

“…A subsequent study by Sripanidkulchai et al reported the oral pharmacokinetics of compound 9 in rats administered Kaempferia parviflora extract, of which compound 9 was a major component. Recently, a clinical trial by the same group further evaluated the oral pharmacokinetics and metabolites of compound 9 after administration of K. parviflora extract.…”