薬理と治療
Volume 46, Issue 6, 2018
Volumes & issues:
-
扉・目次
-
-
-
TOPICS 第17回CRCと臨床試験のあり方を考える会議 2017 in 名古屋
-
- シンポジウム3/治験の国際化の中で我々はどのように変わっていくべきか~ICH-E6 を中心に~
-
-
-
-
- シンポジウム10/治験審査委員会・倫理審査委員会の審査の質向上のための取り組み
-
-
-
-
TOPIC
-
-
-
ORIGINAL ARTICLES
-
-
茶カテキンの日本人成人に対する内臓脂肪への効果―ランダム化比較試験のIndividual Participant Data メタアナリシス―
46巻6号(2018);View Description Hide DescriptionBackground Tea catechins have been showed to reduce visceral fat and body weight. This individual participant data(IPD)meta-analysis was to assess the overall effect of tea catechin supplementation(tea catechins rich beverage)on Japanese healthy adults. Design Systematic review and meta-analysis of individual participant data(IPD)from randomized, double-blind, placebo-controlled trials. Data sources Medline(PubMed), JDream Ⅲ and University hospital Medical Information Network (UMIN)Clinical Trials Registry from inception to January 2018. Eligibility criteria for selecting studies Randomized, double blind, placebo controlled trials of ingestion of tea catechins(tea catechins rich beverage)for 12 or more weeks were eligible for inclusion if data of body fat or visceral fat were collect and if participants were Japanese adults. Results Seven eligible randomized controlled trials(total 1052 participants)were identified. IPD were obtained for 1049 participants. Tea catechins reduced abdominal visceral fat area (-8.83 cm2; 95% confidence interval -11.14 to -6.52), abdominal subcutaneous fat area (-11.45 cm2; 95% confidence interval -14.34 to -8.55), and abdominal total fat area (-20.66 cm2; 95% confidence interval -24.71 to -16.61). Adverse effects caused by tea catechins were not observed. Conclusions Tea catechins have body fat and visceral fat reducing effects in Japanese healthy adults. -
モノグルコシルルチン配合緑茶の12 週間継続摂取による脂質代謝に対する有効性および安全性の評価―プラセボ対照ランダム化二重盲検並行群間比較試験―
46巻6号(2018);View Description Hide DescriptionObjectives We evaluated the effects and safety of green tea containing mono-glucosylrutin on lipid metabolism in this randomized, double-blind, placebo-controlled, parallel-group comparison study. Methods One hundred healthy Japanese people with a low-density lipoprotein cholesterol (LDL-C)level≥120 mg╱dL and<160 mg╱dL were randomly divided into test and placebo groups. Subjects drank test green tea(containing 65 mg mono-glucosylrutin)or placebo green tea(not containing mono-glucosylrutin)daily for 12 weeks. Physical, blood, and urinary examinations and medical interviews were conducted at weeks 0, 4, 8, and 12, and at 4 weeks after the end of the trial period. Results LDL-C did not significantly differ between the groups. However, there were differences over time for apolipoprotein(Apo)AI and the Apo B╱Apo AI ratio, and Apo AI, the Apo B╱Apo AI ratio, and the LDL-C╱high-density lipoprotein cholesterol(HDL-C)ratio improved with intake of test green tea at 4 weeks after the end of the trial. Bodyweight significantly decreased in the test group at weeks 4, 8, and 12. No abnormal changes or severe adverse events were observed with physical, blood, and urinary examinations nor reported during medical interviews during the trial. Conclusions Green tea containing mono-glucosylrutin was safe over the long term and improved apolipoprotein in lipid metabolism, the LDL-C╱HDL-C ratio, and bodyweight. (UMIN-CTR ID:000021452) -
ルイボスエキス含有食品による口,目,肌のヒト乾燥改善機能―ランダム化プラセボ対照二重盲検比較試験―
46巻6号(2018);View Description Hide DescriptionObjective We investigated effects of food containing rooibos(Aspalathus linearis) extract including eriodictyol-6-C-glucoside(E6CG)on dryness of mouth, eye, and skin in human in a randomized, double-blind, placebo-controlled, crossover trial. Methods Thirty healthy adults with subjective dryness of multiple parts in mouth, eye, and skin were randomly devided into 2 groups and then instructed to intake either 100 mg of rooibos extract(0.21 mg of E6CG)or placebo for 2 weeks, respectively. The subjective dryness indices using the visual analog scale and the objective indices based on saliva flow rate, tear volume, and stratum corneum moisture content were evaluated before and after intake of the foods. This study was registered with UMIN Clinical Trials Registry as UMIN 000029492. Results Rooibos extract intake significantly improved the subjective dryness of mouth(P=0.019), eye(P=0.006)and skin(P=0.030)and the objective indices of saliva flow rate(P=0.045), tear volume(P=0.012)and stratum corneum moisture content(P=0.004). Conclusions This clinical study demonstrated that rooibos extract intake improves dryness of mouth, eye and skin. -
植物発酵エキス“野草酵素”が血流に与える影響―二重盲検ランダム化プラセボ対照並行群間比較試験―
46巻6号(2018);View Description Hide DescriptionObjective YASOUKOUSO, derived from multiple wild plants and fruits, is expected to improve blood flow rate. We investigated the blood flow rate following intake of a test beverage for 4 weeks with continuous administration in a randomized, double-blind, placebo-controlled, parallel-group study. Methods Forty-four healthy Japanese subjects satisfied the selection criteria, and they were randomly allocated into two groups(22 subjects per group). The subjects drank a cup of either YASOUKOUSO or the placebo beverage(25 mL)once per day at optional timing for 4 weeks. Blood flow perfusion and blood capillary were measured, and the safety of the test beverage was also evaluated. Results Two subjects dropped out in the study and therefore, were excluded from the analysis. Of the 42 subjects included in the analysis, 21 were in the YASOUKOUSO group(5 male and 16 female, mean age±SD, 48.2±7.7 years)and 21 subjects were in the placebo group(5 male and 16 female, mean age±SD, 48.0±8.2 years). After the intake of the test beverage, the blood flow perfusion rate significantly increased in the YASOUKOUSO group compared with that in the placebo group(P=0.039). No safety concerns were observed during the intervention period. Conclusions The result suggests that the intake of YASOUKOUSO improves the blood flow. In addition, the intake of YASOUKOUSO was safe under the conditions of this study. Trial Registration UMIN-CTR: UMIN000028182 -
ビルベリーエキス,ルテイン含有食品摂取による眼機能への有効性検証試験―二重盲検プラセボ対照並行群間ランダム化比較試験―
46巻6号(2018);View Description Hide DescriptionObjective Benefits of bilberry extract or lutein to the eyes have been evaluated in clinical trials for healthy volunteers. However, the effect of simultaneous intake of bilberry extract and lutein has not been investigated. The purpose of this study was to investigate the effect of simultaneous intake of bilberry extract and lutein on eye functions of healthy adults. Method We conducted a double-blind placebo-controlled randomized clinical trial(UMIN 000028736) with forty healthy Japanese subjects aged from 20 to 47. The participants took either placebo or BL(120 mg of bilberry extract and 6 mg of lutein)for 12 weeks. At week 0 and 12, HFC-1 scores measured before and after visual display terminal(VDT)load for 30 minutes. Serum lutein concentrations, macular pigment optical density(MPOD), and contrast sensitivity(CS)were also evaluated. Results BL group showed a significant improvement on the variation in HFC-1 scores after VDT load between week 0 and 12, as compared to placebo group. Serum lutein concentrations, MPOD and CS were significantly increased in BL group compared with placebo group. No significant adverse events were observed in the study. Conclusion Our results suggest that simultaneous consumption of lutein and bilberry extract does not interfere with each otherʼs clinical benefit of the eye. In addition, the BL product seemed to be safe under the test conditions carried out. -
Effect of a Dietary Supplement ContainingPorcine Placenta Extract on Skin Hydration―A Placebo—controlled, Randomized,Double—blind, Clinical Study―
46巻6号(2018);View Description Hide DescriptionObjectives The aim of this study was to evaluate the effect of a dietary supplement containing porcine placenta on skin hydration. Methods The study was a randomized, placebo-controlled, double-blind, clinical trial. Forty-five healthy subjects without skin problems or diseases were enrolled and randomly divided into three groups who were respectively given a placebo, a dietary supplement containing porcine placenta extract(DSPPE), and a dietary supplement containing a vitamin (DSV)group. The subjects were given three capsules daily(including porcine placenta extract(containing 600μg of Glycyl-L-Leucine(Gly-Leu)+L-Leucyl-Glycine(Leu-Gly) dipeptides)) for eight weeks. Skin hydration and transepidermal water loss(TEWL)were evaluated using Corneometer CM 825 and Tewameter TM300(R) devices. A quality-of-life (QOL)questionnaire and blood samples were tested to assess the safety of the test product. This study was registered in UMIN-CTR⎝UMIN 000026030⎠. Results There was a statistically significant difference in skin hydration levels after eight weeks on the cheek(P<0.05)and arm(P<0.01)between the placebo and the DSPPE groups. A significant increase was observed on the arm after eight weeks of DSPPE ingestion compared to that before ingestion(P<0.01). Moreover, TEWL data showed a tendency to decrease after four weeks and eight weeks of ingestion in the DSPPE intervention group from the cheek. The results of the blood test and the QOL questionnaire did not show any health risks from the use of these test supplements. No additional adverse events occurred. Conclusions These results suggest that the ingestion of DSPPE has the potential to improve skin hydration and skin conditions in healthy subjects. -
ポリアミンおよびヌクレオチド含有トルラ酵母エキスの美肌効果―ランダム化二重盲検並行群間比較試験―
46巻6号(2018);View Description Hide DescriptionObjective To evaluate the efficacy of polyamine and nucleotide containing torula yeast extract on the skin, a randomized double-blind, parallel-group study was conducted for healthy adult females. Methods 30 healthy females(20 to 59 years old)took hard capsules containing 60 mg of polyamine and nucleotide containing torula yeast extract or placebos 5 tablets a day for 8 weeks. The primary endpoints were amounts of keratin moisture, spots, wrinkles, pores, color unevenness, porphyrin. Results After 8 weeks intake of polyamine and nucleotide containing torula yeast extract significantly increased amounts of keratin moisture and decreased wrinkles and color unevenness as compared with subjects with placebo. Conclusions The results indicated that long-term continuous ingestion of polyamine and nucleotide containing torula yeast extract is effective in increasing the amount of keratin moisture, decreasing pores, reducing wrinkles, color unevenness in the skin. -
大学生女子運動選手における食品群別摂取状況ならびに睡眠状況調査
46巻6号(2018);View Description Hide DescriptionObjectives The aim of this study was to investigate the sleep quality and the nutritional intakes in female university athletes. Methods The subjects of this study were 63 female University athletes. Sleep quality was assessed using the Pittsburg Sleep Quality Index(PSQI). Nutritional intakes were measured with a brief-type self-administered diet history questionnaire(BDHQ). The measurements were made from August to September in 2015. Ultimately, 54 female University student- athletes were included in the study. Results The mean night time sleep duration was 7(6-7)hours. Sixty one percent of the athletes were over the cut-off levels for PSQI. Poor sleep quality was associated with low intake of green and yellow vegetable(P<0.044). Conclusions:These results suggest that those with a risk of sleep disorder may be affecting dietary situations and lifestyle habits. -
モノグルコシルルチン配合緑茶の過剰摂取による非盲検非対照安全性確認試験
46巻6号(2018);View Description Hide DescriptionObjectives We conducted an open-label, uncontrolled trial to evaluate the safety of excess intake of green tea containing mono-glucosylrutin. Methods Thirty participants were included including healthy people(n=10), borderline obese(body mass index≥23 and<30)(n=10), and people with borderline hyperlipidemia (low-density lipoprotein cholesterol≥120 mg╱dL and<160 mg╱dL)(n=10). One dose(4.0g)of the test green tea contained 65 mg mono-glucosylrutin. Participants were given three doses per day for 4 weeks. Physical, blood, and urinary examinations and medical interviews were conducted at weeks 0, 2, and 4 and at 2 weeks after the end of the trial period. Results No abnormal changes or severe adverse events were observed with physical, blood, and urinary examinations nor reported during medical interviews during the trial. Conclusions Excess intake of green tea containing mono︱glucosylrutin is safe in people who are healthy, borderline obese, or with borderline hyperlipidemia. (UMIN-CTR ID:000022244)
-
-
SERIES
-
-
-
INFORMATION
-
-
-
CONSORT 2010声明―ランダム化並行群間比較試験報告のための最新版ガイドライン―(薬理と治療2010;38:939-49. より再掲載)
46巻6号(2018);View Description Hide Description -
-
-