Random controled study for evaluate the effects of consumption of the test beverage on sleep quality

UMIN ID: UMIN000054707

Registered date:19/06/2024

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

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: Not applicable
• Gender: Male and Female
• 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
• Source(s) of Monetary Support: Koueki Syadanhoujin Isyokudougen Shouyaku Kenkyu Zaidan