None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female aged 20-59 2. Persons who feel fatigue on a daily basis 3. Persons who agree to use the wearable device (Fitbit), install the Fitbit application on their smartphone, and create a Google account for the study.
Exclusion criteria
Exclusion criteria: 1. Person who has suffer from chronic diseases currently (diabetes, hypertension, hyperlipidemia, gout, kidney disease, rheumatism, respiratory disease, etc.) and are taking medication. (however, users of drugs that suppress allergic symptoms such as allergic rhinitis can be included in the subjects) 2. Person who has difficulty participating in research due to liver, kidney, heart disease, respiratory disorder, endocrine disorder, metabolic disorder, neurological disorder, consciousness disorder, diabetes, or other diseases. 3. Person diagnosed with insomnia, sleep apnea, or other sleep disorders 4. Person diagnosed with chronic fatigue syndrome 5. Person taking sleeping pills 6. Person who with alcoholic drinkers. (alcohol equivalent 60g / day or more) : (Beer: 3 medium bottles (1.5L), Sake: 3 go (540ml), Whiskey: 3 double glasses (180ml), Shochu: 1.8go (330ml) or more) 7. Person who plans to participate in other clinical trials during the trial participation period. 8. Currently pregnant or intending to become pregnant during the period of study participation. 9. Person who has a history of drug dependence, alcohol dependence, or current medical history. 10. Person who plans to travel, go on business, or vacation for more than 4 consecutive days during the measurement period. 11. Person working in shifts and night shifts 12. Person with injuries or pain that affect normal walking 13. Person who is allergic to any of the ingredients in the test food. 14. Person who is prone to skin irritation from adhesive tapes and other products that stick to the skin. 15. Person who may not be able to consume ingredients whose origin is not specified in the test food due to religious or other reasons. 16. Person who is planning to undergo a major life change such as going to school, getting a job, or moving during the measurement period. 17. Person who has deemed inappropriate to participate in this study by the principle investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of change in fatigue VAS | — |
Secondary
| Measure | Time frame |
|---|---|
| Questionnaires such as the OSA (Onset Sleep Assessment) Autonomic nervous system status by heart rate variability analysis, blood pressure, etc. Measurements of mental alertness Sleep state (sleep latency, mid-awake, heart rate on awakening, resting heart rate) | — |
Countries
Japan
Contacts
Kao Corporation Human Health Care Products Research