Healthy volunteers
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)Males and females whose age of 30 years or more and less than 65 years 2)Persons having fatigue sensation in daily life 3)Persons with a BMI of 18.5 kg/m2 or more and less than 25.0 kg/m2 4)Persons receiving 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)Persons receiving medical treatment for serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders 2)Persons having been diagnosed with chronic fatigue syndrome or idiopathic chronic fatigue 3)Persons drinking a lot (Persons whose pure alcohol intake per day is 60 g or more) 4)Persons having the possibility of developing allergic symptoms by the test food 5)Persons whose lifestyles are irregular because of night shift or others 6)Persons planning a oversea trip during the study period 7)Persons taking regularly medicines and quasi-drugs having the effects on fatigue 8)Persons taking regularly Food with Functional Claims having the effects on fatigue sensation 9)Persons who are pregnant or lactating, or intending to become pregnant during the study 10)Persons 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 11)Persons deemed unsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS (fatigue sensation) | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS [sleepiness, motivation (vigor), perceived stress], Chalder fatigue scale, OSA sleep inventory MA version | — |
Countries
Japan
Contacts
Soiken Inc. R&D Division