JPRN-UMIN000052586已完成Unknown
Effects of consumption of the test food on sleep in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study - Effects of consumption of the test food on sleep in healthy Japanese
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
- •Individuals who 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 (ICD) 3. are currently undergoing treatment for cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. are 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 study 8. have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate another study during this study 9. have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues 10. have irregular sleeping time or habit due to work such as a late-night shift 11. live with their infants less than one year old 12. sleep with their children (1 to 6 years old) 13. live with requiring long-term care persons 14. sleep with more than one person 15. have nocturia three times or more 16. drink to excess (average of more than about 20 g/day as pure 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)} 17. have irregular lifestyles (such as diet, exercise, and sleep) 18. are undergoing medical treatment for chronic fatigue syndrome or menopausal syndrome 19. work in physical labor such as transportation of heavy objects 20. are judged as ineligible to participate in this study by the physician
研究者
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