Healthy volunteers
Conditions
Interventions
Intake of test food for 2 weeks ->
Washout period (2 week) ->
Intake of placebo for 2 weeks
Intake of placebo for 2 weeks ->
Sponsors
Soiken Inc.
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 regarding 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 who take regularly medicines and quasi-drugs having the effects on sleep quality 5)Subjects who take regularly health food (e.g. Food with Functional Claims) having the effects on sleep quality 6)Subjects whose lifestyles are irregular because of night shift or others 7)Subjects who wake up for urination 2 times or more during nocturnal sleep 8)Subjects who drink a lot (Subjects whose pure alcohol intake per day is 60 g or more) 9)Subjects who have smoking habit 10)Subjects who have the possibility of developing allergic symptoms by the test food 11)Subjects who live with their infants less than 1 year old 12)Subjects who sleep with others in a bedroom 13)Subjects having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood) 14)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 15)Female subjects who are pregnant or lactating, or intending to become pregnant during the 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, Sleep & activity tracker (sleep minutes, sleep latency, sleep efficacy, minutes of awakening during sleep, number of awakenings), Oxidative stress parameters (d-ROMs, BAP), VAS (fatigue sensation) | — |
Countries
Japan
Contacts
Public ContactMai Hamada
Soiken Inc. R&D Division
Outcome results
None listed