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临床试验/JPRN-UMIN000042444
JPRN-UMIN000042444已完成未知

Effects of consumption of the test food on sleep quality: A randomized, double-blind, placebo-controlled, parallel-group comparison trial - Effects of consumption of the test food on sleep quality

ORTHOMEDICO Inc.0 个研究点目标入组 56 人开始时间: 2020年11月13日最近更新:

试验速览

阶段
未知
状态
已完成
入组人数
56

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
20years-old 至 ot applicable(—)
性别
All

入选标准

  • 未提供

排除标准

  • 1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects who are currently undergoing treatment for cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who are currently undergoing treatment of insomnia or sleep disorder 5. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use 6. Subjects who are currently taking medicines (include herbal medicines) and supplements 7. Subjects who are allergic to medications and/or the test-food-related products 8. Subjects who live with their infants less than one year old 9. Subjects who co-sleep with their children (one to six years old) 10. Subjects who live with requiring long-term care persons 11. Subjects who share the bed with more than one person 12. Subjects who work late-night shift and the life-styles are irregular 13. Subjects whose dinner time is extremely irregular 14. Subjects who have nocturia three times or more 15. Subjects who drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)} 16. Subjects who pregnant, breast-feeding, and planning to become pregnant 17. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 18. Subjects who are judged as ineligible to participate in the study by the physician

研究者

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