Healthy adult
Conditions
Interventions
Intake of placebo (single ingestion) - washout period - Intake of test beverage (single ingestion)
Intake of test beverage (single ingestion) - washout period - Intake of placebo (single ingestion)
Sponsors
EP Mediate Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy males and females from 30 to 49 years of age 2. BMI less than 30 kg/m2 at the time of pre-examination 3. Participants who are aware that they are prone to stress and tension in their daily lives 4. Participants with elevated T-scores of TA (tension-anxiety) on the POMS2-AS at the time of pre-examination 5. Participants who fully understand the purpose and content of the research and agree to participate in the research of their own free will
Exclusion criteria
Exclusion criteria: 1. Participants receiving treatment related to sleep, stress, and fatigue 2. Participants who consume functional foods and other health foods related to sleep, stress, fatigue, and tension at least a day per week 3. Participants who are being treated for, have a history of, or are suspected of having a mental disorder 4. Participants determined to have a major depressive episode 5. Participants who diagnosed or suspected as sleep apnea syndrome 6. Participants who have been diagnosed with insomnia 7. Participants who have been diagnosed with chronic fatigue syndrome 8. Heavy alcohol drinkers (60 g/day as alcohol content) 9. Participants with a smoking habit (except those who have been smoke-free for more than 6 months) 10. Participants with irregular life rhythms 11. Participants engaged in physical labor 12. Participants with problems or diseases in the oral cavity that are determined to affect saliva testing 13. Participants who plan to undergo dental treatment or hospital visits during the study period 14. Participants who have participated in a study with stress test 15. Participants having possibilities for emerging allergy 16. Participants who have disease that requires constant medication 17. Participants who regularly use medicines (including traditional chinese medicines), or have a serious medical history that requires medication 18. Participants whose physical measurements, physical examination values, and clinical examination values at the time of pre-examination are significantly out of the reference range 19. Participants who have participated in another study within a month prior to the present study, or who plan to participate in other studies 20. Participants who plan to become pregnant or breastfeed 21. Participants who are judged to be unsuitable as subjects based on the answers to the background survey 22. Participants who are judged as unsuitable for the study by the principal investigator for other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Profile of Mood States 2nd Edition-Adult Short (T score of TA) | — |
Secondary
| Measure | Time frame |
|---|---|
| Profile of Mood States 2nd Edition-Adult Short (T scores of other scales) VAS (fatigue, tension, stress) Cortisol level in saliva, Chromogranin A level in saliva | — |
Countries
Japan
Contacts
Public ContactHiroyasu Shimada
EP Mediate Co., Ltd. Development Department Trial Planning Section
Outcome results
None listed