UMIN ID: UMIN000054707
Registered date:19/06/2024
Random controled study for evaluate the effects of consumption of the test beverage on sleep quality
Basic Information
Recruitment status | Pending |
---|---|
Health condition(s) or Problem(s) studied | Healthy volunteers |
Date of first enrollment | 2024/07/01 |
Target sample size | 120 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Consumption of test food A for three week (Once a day, two hours before sleep) Consumption of test food B for three week (Once a day, two hours before sleep) Consumption of test food C for three week (Once a day, two hours before sleep) Consumption of placebo for three week (Once a day, two hours before sleep) |
Outcome(s)
Primary Outcome | Brain waves during sleep |
---|---|
Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | 40years-old |
---|---|
Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
Exclude criteria | 1) Subjects receiving a medical treatment for sleep disorders 2) Subjects receiving a medical treatment for serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders 3) Subjects receiving a medical treatment for chronic diseases 4) Subjects whose sleeping styles are irregular because of night shift or others 5) Subjects regularly taking medicines or Food with Functional Claims having the effects on sleep quality 6) Subjects having the possibility of developing allergic symptoms by the test food 7) Subjects who took part in another clinical study within 4 weeks prior to the start of the present study or who is currently taking part in another clinical study 8) Subjects deemed unsuitable by the investigator |
Related Information
Primary Sponsor | Kagoshima University |
---|---|
Secondary Sponsor | |
Source(s) of Monetary Support | Koueki Syadanhoujin Isyokudougen Shouyaku Kenkyu Zaidan |
Secondary ID(s) |
Contact
public contact | |
Name | Daisuke Furushima |
Address | 8-35-1, Sakuragaoka, Kagoshima, Japan Japan 890-8544 |
Telephone | 0992756793 |
dfuru@health.nop.kagoshima-u.ac.jp | |
Affiliation | Kagoshima University School of Health Science, Faculty of medicine |
scientific contact | |
Name | Daisuke Furushima |
Address | 8-35-1, Sakuragaoka, Kagoshima, Japan Japan |
Telephone | 0992756793 |
dfuru@health.nop.kagoshima-u.ac.jp | |
Affiliation | Kagoshima University School of Health Science, Faculty of medicine |