Healthy volunteers
Conditions
Sponsors
Japan Preventive Medicine 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 having fatigue sensation in daily life 3) Subjects who having complaints regarding daily sleep 4) 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 serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders 2) Subjects drinking a lot (Subjects whose pure alcohol intake per day is 60 g or more) 3) Subjects having the possibility of developing allergic symptoms by the test food 4) Subjects whose lifestyles are irregular because of night shift or others 5) Subjects waking up for urination 2 times or more during nocturnal sleep 6) Subjects living with their infants less than 1 year old 7) Subjects sleeping with others in a bedroom 8) Subjects taking regularly medicines and quasi-drugs having the effects on fatigue sensation, cognitive function and sleep quality 9) Subjects taking regularly Food with Functional Claims having the effects on fatigue sensation, cognitive function and sleep quality 10) 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) 11)Subjects who are pregnant or lactating, or intending to become pregnant during the study 12) 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 13) Subjects deemed unsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS (fatigue sensation) | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS (sleepiness, motivation, concentration), Chalder fatigue scale, POMS2 Japanese version, autonomic nervous function, blood analysis (adrenalin, noradrenalin, dopamine, d-ROMs, BAP), saliva analysis (HHV-6, HHV-7), cognitive function test, OSA sleep inventory MA version, The St. Mary's Hospital sleep questionnaire, objective sleep evaluation | — |
Countries
Japan
Contacts
Public ContactTadakazu Takigami
Japan Preventive Medicine Inc. Research and Development
Outcome results
None listed