Evaluation of the Safety of Daily Consumption of Kaempferia parviflora Extract (KPFORCE): A Randomized Double-Blind Placebo-Controlled Trial.

This study's aim was to evaluate the safety of daily consumption of Kaempferia parviflora extract (KPE) using a randomized double-blind placebo-controlled study with 52 recruited healthy Japanese subjects. Each subject received five KPE tablets (containing 150 mg of KPFORCE™/tablet) or placebo daily for 4 weeks. There were no adverse events related to KPE intake or any abnormalities compared with placebo group in anthropometric, cardiovascular, blood, and urine parameters during the course of the study. Thus, daily KPE ingestion was found to be safe in healthy Japanese men and women.

Daily intake of Kaempferia parviflora extract decreases abdominal fat in overweight and preobese subjects: a randomized, double-blind, placebo-controlled clinical study.

PURPOSE: Obesity is a serious problem, which is now a worldwide health problem. Kaempferia parviflora extract (KPE) exhibits anti-obesity effects in animals. However, as no clinical trials have evaluated the anti-obesity effects of KPE in humans, we examined the effects of KPE in reducing abdominal fat in overweight and preobese Japanese subjects. MATERIALS AND METHODS: A 12-week, single-center, randomized, double-blind, placebo-controlled clinical trial was conducted. Seventy-six subjects (males and females aged 20 to <65 years) with a body mass index ≥24 and <30 kg/m2 were randomly assigned into two groups. The subjects in each group ingested one capsule of placebo or active KPE (containing 150 mg of KPE) once daily for 12 weeks. The primary outcome was reduction in visceral fat area as determined by computed tomography scanning. The key secondary outcomes were reductions in subcutaneous fat area and total fat area. Subgroup analysis was also performed in healthy subjects without dyslipidemia, hypertension, or hyperglycemia. The safety of KPE ingestion was also evaluated. RESULTS: Compared with the placebo group, the active KPE group exhibited significant reduction in abdominal fat area (visceral, subcutaneous, and total fat) and triglyceride levels after 12 weeks. Subgroup analyses demonstrated a significant reduction in abdominal fat area and triglyceride levels in healthy subjects compared with the placebo group after 12 weeks. Neither group exhibited adverse events related to the test foods or clinically relevant abnormal changes in physical, biochemical, or hematologic parameters, or in urinalysis results and medical interview. CONCLUSION: Daily ingestion of KPE safely reduces body fat, particularly abdominal fat, in Japanese overweight and preobese subjects.

Preclinical evaluation of an O(6)-methylguanine-DNA methyltransferase-siRNA/liposome complex administered by convection-enhanced delivery to rat and porcine brains.

The main determinant of glioblastoma (GBM) resistance to temozolomide (TMZ) is thought to be O(6)-methylguanine-DNA methyltransferase (MGMT), which is a DNA-repair enzyme that removes alkyl groups from the O(6)-position of guanine. Previously, we reported that a MGMT-siRNA/cationic liposome complex exerted a clear synergistic antitumor effect in combination with TMZ. Translation to a clinical setting might be desirable for reinforcing the efficacy of TMZ therapy for GBM. In this study, we aim to evaluate the safety of MGMT-siRNA/cationic liposome complexes and determine whether the convection-enhanced delivery of these complexes is suitable for clinical use by undertaking preclinical testing in laboratory animals. No significant adverse events were observed in rats receiving infusions of MGMT-siRNA/cationic liposome complex directly into the brain with or without TMZ administration. A pig which received the complex administered by CED also showed no evidence of neurological dysfunction or histological abnormalities. However, the complex did not appear to achieve effective distribution by CED in either the rat or the porcine brain tissue. Considering these results together, we concluded that insufficient distribution of cationic liposomes was achieved for tumor treatment by CED.