薬理と治療
Volume 42, Issue 4, 2014
Volumes & issues:
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扉・目次
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TOPICS:第13回CRCと臨床試験のあり方を考える会議 2013 IN 舞浜
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- シンポジウム6 /同意取得,同意撤回等に対する考え方
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SERIES 医療の現場から④
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ORIGINAL ARTICLES
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難消化性デキストリン配合炭酸飲料の食後中性脂肪上昇抑制作用および長期摂取時,過剰摂取時における安全性の検証
42巻4号(2014);View Description Hide DescriptionObjectives We developed carbonated beverage containing resistant maltodextrin(RMD). A randomized, double︱blind crossover study was carried out to investigate whether the beverage would suppress the postprandial elevation of the serum triglyceride(TG)levels, remnant like lipoprotein particle(RLP)︱cholesterol levels. Also, two randomized double︱blind placebo︱controlled studies were carried out to assess the safety of excessive or long︱term intake of the beverage.Methods The subjects were 90 healthy volunteers(serum TG:120︱200 mg╱dL). The subjects ingested a test beverage containing RMD(5 g)or beverage without RMD(placebo)together with fat︱rich meal(lipid:42.1 g). Blood samples were drawn before and 2, 3, 4 and 6 hours after ingestion, and the serum triglyceride levels were measured. The subject for safety evaluation of long︱term intake was 30 healthy volunteers, including 10 volunteers whose serum TG levels were 150︱200 mg╱dL. They consumed one bottle of test beverage(485 mL╱bottle)containing RMD(5 g)at a meal per day for 12 weeks. The subject for safety evaluation of excessive intake was 30 healthy volunteers, including 10 volunteers whose serum TG levels were 150︱200 mg╱dL. They consumed one bottle of test beverage containing RMD(15 g)at a meal per day for 4 weeks. Results Intake of RMD beverage significantly suppressed the level of serum TG observed at 2, 3 and 4 hours after food ingestion as compared with that of the placebo(P<0.05). Postprandial RLP︱cholesterol elevation also significantly suppressed at 3, 4 and 6 hours after food ingestion as compared with that of the placebo(P<0.05). Also, there were no clinical problems in the blood examinations and physical examinations. No adverse reactions were observed. Conclusions These results indicated that intake of the RMD supplemented beverage suppresses postprandial serum triglyceride levels without any safety problem. -
栄養飲料摂取が地域在住の元気高齢者の栄養素摂取量および身体組成,血液生化学検査値に及ぼす影響
42巻4号(2014);View Description Hide DescriptionObjectives The objective of this study was to report the effectiveness of supplemental drinks on dietary intake, biochemical data, and body composition in community︱healthy elderly individuals. Methods Thirty︱five participants were randomized to a control group(n=14)or an intervention group(n=11). Those in the intervention group were asked to drink a pack of supplemental drink each day for 2 months. Results The intake of supplemental drink for 2 months resulted in increased weight and increased intake of energy and most nutrients except for vitamin A and iodine. Serum 25︱dehydroxy vitamin D levels increased in the intervention group. Furthermore, bone mineral density decreased in the control group, but not in the intervention group. Conclusions Supplemental drinks offer an easy way to both increase the intake of nutrients and prevent malnutrition, and might facilitate an increase in bone mineral content and prevention of falls and fractures. -
ペポカボチャ種子エキスを配合した「養生®」食品さわやか紳士,さわやか婦人の排尿障害に及ぼす作用
42巻4号(2014);View Description Hide DescriptionObjectives Effects of“Sawayaka︱Shinshi”and“Sawayaka︱Fujin”:functional foods containing Pumpkin(Cururbita pepo L.)seed extract, on urinary disorder were investigated in adults. Methods An Open study participated by 25 healthy subjects(13 males and 12 females)was conducted for 30 days, followed by 15 days observation period. The participants consumed samples:male, Sawayaka︱Shinshi;female, Sawayaka︱Fujin, twice a day after morning meal and evening meal. Symptoms of urinary disorder were measured by the international prostate symptom score(IPSS),quality of life(QOL)score, overactive bladder symptom score (OABSS)and Kingʼs health questionnaire(KHQ)at baseline and after 10, 20, 30 days of treatment and also after 15 days following the completion of the treatment. Furthermore, we evaluated symptoms of climacteric disturbance by aging malesʼ symptoms rating scale(AMS) for males and simplified menopausal index(SMI)for females, psychological states in both sexes were examinated by profile of moods states(POMS). Results In both male and female participants, total scores of IPSS and OABSS, QOL score, a number of KHQ scores significantly reduced after 30 days of treatment, compared to the baseline. On the other hand, there was no significant change in each scores of AMS, SMI and POMS. Conclusion Both “Sawayaka︱Shinshi”and“Sawayaka︱Fujin”were useful as functional foods to improve urinary disorder in adults.
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