JPRN-UMIN000051530已完成Unknown
Effects of consumption of the test food on sleep quality in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study - Effects of consumption of the test food on sleep quality in healthy Japanese subjects
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 112
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
- 18years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •Subjects (who/whose) 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator 3. currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. currently taking medications (including herbal medicines) and supplements 6. are allergic to medicines and/or the test food related products 7. are pregnant, lactating, or planning to become pregnant during this trial 8. have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 9. are judged as ineligible to participate in this study by the physician 10. live with their infants less than one year old 11. sleep with their children (1 to 6 years old) 12. live with and need to care for those in requiring long-term care 13. sleep with more than one person 14. sleeping time or habit is irregular due to work such as a late-night shift 15. have nocturia two times or more 16. have irregular lifestyles (such as inconstant eating time, insufficient sleeping time) 17. usually 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)} 18. are undergoing treatment of insomnia or sleep disorder, or take sleep-inducing drugs or other medications 19. take food/beverage containing functional ingredients which may influence sleep quality (such as gamma-aminobutyric acid, crocetin, L-theanine, and lactic acid bacteria)
研究者
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