Healthy adult
Conditions
Interventions
Intake of food containing rice protein hydrolysate for 4 weeks and single ingestion
Intake of placebo for 4 weeks and single ingestion
Sponsors
EP Mediate Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy males and females from 20 to 64 years of age (2) Subjects who have taken POMS2-AS on preliminary examination(2) and (3) and have scored FI T score 50 points and more, and VA T score 50 points and less at least once
Exclusion criteria
Exclusion criteria: (1) Subjects who regularly go to mental hospital or fill the standard of Major Depressive Episode (2) Subjects who are midnight workers, or sleep between 6 a.m. and 10 a.m. and wake up between 6 p.m. and 8 p.m. at least once a week (3) Subjects who drink an energy drink at least once a week (4) Subjects who perform an act for the improvement of the fatigue, the quality of the sleep and stress (5) Subjects having allergy or having had allergic reaction (6) Subjects having a disease regularly requiring treatment or a history of malignancy which needed taking a medicine regularly except judged as remission (7) Subjects who are judged that the results of clinical and physical examination on preliminary examination are more than decision criteria D laid down by Japan Society of Ningen Dock (8) Subjects who are participated in other clinical study (9) Subjects who intend to become pregnant or lactating (10) Subjects who are judged as difficult to carry out the procedures of various tests and to obey the restrictions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mood scale (POMS2-AS scores, Euthymia scale) | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia Severity Inventory | — |
Countries
Japan
Contacts
Public ContactYoshimi Bansho
EP Mediate Co., Ltd. Development Business Headquarters, TTC Center, Trial Planning Department
Outcome results
None listed