ABSTRACT
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.
Subject(s)
Plant Extracts/administration & dosage , Zingiberaceae/chemistry , Adult , Double-Blind Method , Female , Humans , Japan , Male , Middle Aged , Plant Extracts/adverse effects , TabletsABSTRACT
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.
ABSTRACT
BACKGROUND: Obesity has become a great problem all over the world. We repeatedly screened to find an effective food to treat obesity and discovered that rosehip extract shows potent anti-obesity effects. Investigations in mice have demonstrated that rosehip extract inhibits body weight gain and decreases visceral fat. Thus, the present study examined the effect of rosehip extract on human body fat in preobese subjects. METHODS: We conducted a 12-week, single-center, double-blind, randomized, placebo-controlled study of 32 subjects who had a body mass index of ≥25 but <30. The subjects were assigned to two random groups, and they received one tablet of placebo or rosehip that contained 100 mg of rosehip extract once each day for 12 weeks with no dietary intervention. Abdominal fat area and body fat percent were measured as primary outcomes. The other outcomes were body weight and body mass index. RESULTS: Abdominal total fat area, abdominal visceral fat area, body weight, and body mass index decreased significantly in the rosehip group at week 12 compared with their baseline levels (P<0.01) after receiving the rosehip tablet intake, and the decreases in these parameters were significantly higher when compared with those in the placebo group. Additionally, body fat percent tended to decrease compared with the placebo group and their baseline level. Moreover, the abdominal subcutaneous fat area was significantly lower in the rosehip group than in the placebo group at week 12 after the initiation of intake (P<0.05). In addition, there were no abnormalities, subjective symptoms, and findings that may indicate clinical problems during the study period. CONCLUSION: These results suggest that rosehip extract may be a good candidate food material for preventing obesity.
ABSTRACT
The purpose of the present paper was to examine the psychiatric symptom dimensions related to needs of care among patients with schizophrenia in hospital and in the community. Subjects were 217 patients with F2 ICD-10 diagnoses. Hospital patients included 102 inpatients (47.0%) in psychiatric long-term care units. Community patients included 115 outpatients (53.0%) living in their homes or residential facilities. Psychiatrists used the Brief Psychiatric Rating Scale (BPRS) to assess patients' psychiatric symptoms. Formal care providers assessed needs of care using a scale developed by the Committee on Case Management Guidelines for People with Mental Disabilities in Japan. Instrumental Activities of Daily Living (IADL) self-performance and difficulty were also measured using a scale from the Minimum Data Set-Home Care (MDS-HC). Multiple regression analyses were applied, using the symptom dimensions as dependent variables and needs of care as independent variables. Patient group (hospital or community) was also used as an independent variable. Hospital patients demonstrated more severe psychiatric symptoms and greater needs of care than community patients. Multiple regression analyses showed that the total needs of care were greater among male patients (B = 0.142, P = 0.005), hospital patients (B = 0.310, P < 0.001), patients with poor IADL self-performance (B = 0.217, P = 0.047), and patients with severe negative symptoms (B = 0.240, P = 0.002; R(2) = 0.515). The present results suggested an association between negative symptoms and needs of care in schizophrenia. Hospital patients had greater needs of care, even though their psychiatric symptoms were controlled for. Further research should examine the relationships between psychiatric symptoms and needs of care in a cohort study following patients when hospitalized and when living in the community.
