None listed
Conditions
Interventions
Food containing plant extract, 4 weeks consumption. Wash out. Food not containing plant extract, 4 weeks consumption.
Food not containing plant extract, 4 weeks consumption. Wash out. Food containing
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Healthy Japanese males and females aged 35 to 49 years-old. 2) Subjects who are feeling mental stress or physical fatigue due to the use of PC/smartphone, work, housework, human relationships (including marital relationships), study, etc. 3)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Exclusion criteria
Exclusion criteria: Subjects (who) 1)with irregular sleep hours and sleep habits due to irregular shift work, late night work, etc. 2)have irregular working days or holidays. 3)are judged by doctors to have a high probability of chronic fatigue syndrome. 4)have a probability of depressive symptoms by the screening test(QIDS-J >= 6). 5)contract or are under treatment for serious diseases (e.g., liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, and/or other metabolic disease). 6)contract or have a surgical history of digestive disease affecting digestion and absorption. 7)with sleep apnea syndrome or suspected of sleep apnea syndrome. 8)with a history of and/or current mental illness associated with sleep disorder. 9)have alcohol intake more than approximately 20 g/day of pure alcohol equivalent or a habit of drinking not less than 4 days a week. 10)can't stop drinking from 2 days before each measurement. 11)smoke 20 or more cigarettes a day, or cannot quit smoking during each visit. 12)use supplements, functional foods, or drugs associated with fatigue recovery or lack of sleep. 13)use drugs (such as drugs based on EPA)or supplements (glycine, EPA/DHA, GABA, citric acid, imidazole dipeptides , astaxanthin, coenzyme Q10, etc.) that affects test results. 14)may have allergy to test foods. 15)are pregnant or breast-feeding or planned to become pregnant during the study period. 16)with a history of and/or current drug addiction and/or alcoholism. 17)have donated over 200 mL of blood and/or blood components within the last one month prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study. 18)are participating in or willing to participate in other clinical studies. 19)are judged as unsuitable for the current study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleepiness | — |
Secondary
| Measure | Time frame |
|---|---|
| Other questionnaire Task performance evaluation Clinical examination items | — |
Countries
Japan
Contacts
Public ContactYoshika Komori
KSO Corporation Sales department
Outcome results
None listed