Healthy volunteers
Conditions
Interventions
Consumption of test food for two week (one bottle a day)
Consumption of placebo for two week (one bottle a day)
Sponsors
Ezaki Glico Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Males and females whose age of 20 years or more and less than 65 years 2) Subjects who have complaints for sleep 3) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
Exclusion criteria
Exclusion 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 such as diabetes, hypertension and dyslipidemia 4) Subjects whose lifestyles are irregular because of night shift or others 5) Subjects having some problems in nocturnal sleep occurred from past irregular shift work 6) Subjects waking up for urination 2 times or more during nocturnal sleep 7) Subjects living with their infants less than 1 year old 8) Subjects sleeping with others in the same bedroom 9) Subjects drinking a lot (Subjects whose pure alcohol intake per day is 60 g or more) 10) Subjects regularly taking medicines and quasi-drugs having the effects on sleep quality 11) Subjects regularly taking Food with Functional Claims having the effects on sleep quality 12) Subjects who have severe allergic rhinitis. 13) Subjects having the possibility of developing allergic symptoms by the test food 14) Female subjects who are pregnant or lactating, or intending to become pregnant during the study 15) Subjects who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study 16) Subjects deemed unsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OSA sleep inventory MA version | — |
Secondary
| Measure | Time frame |
|---|---|
| St. Mary's Hospital Sleep Questionnaire, activity tracker | — |
Countries
Japan
Contacts
Public ContactTomohiro Sugino
Soiken Inc. R&D Division
Outcome results
None listed