Healthy adult (worker)
Conditions
Interventions
Sponsors
EP Mediate Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy worker between the ages of 20 and 64. (2) Subjects with a total score of 6 or more on the Pittsburgh questionnaire at the time of pre-examination.
Exclusion criteria
Exclusion criteria: (1) Subjects who routinely use food containing of abundant Bacillus natto, health foods, quasi-drugs, or drugs. (2) Subjects who act for the purpose of improving sleep, stress, fatigue (including hospital visits and treatment), and use medicines and health foods. (3) Night and day shift worker or manual laborer. (4) Subjects who have a disease that is being treated or who have a disease that is deemed to require treatment. (5) Subjects who are under treatment or have a history of serious diseases (e.g., diabetes, liver disease, kidney disease, or heart disease). (6) Subjects who are a history of mental illness (e.g., depression). (7) Subjects having possibilities for emerging allergy related to the study. (8) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire and other questionnaires. (9) Subjects who cannot carry out the procedures of various tests to be carried out during this study. (10) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination before intake. (11) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study. (12) Subjects who are planned to become pregnant or are pregnant or lactating. (13) Subjects who are judged as unsuitable for the study by the investigator for other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) Athens Insomnia Scale (2) The Japanese version of the Pittsburgh Sleep Quality Index (3) OSA sleep inventory MA version Evaluate before ingestion and 4 to 8 weeks after ingestion. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Salivary s-IgA secretion rate (2) Stress markers in the blood (DHEA-S, Cortisol) (3) POMS2 shortened version for adults (4) Fatigue VAS (5) Fatigue accumulation self-diagnosis checklist (6) Uchida-Kraepelin test (7) Purdue Pegboard Test Evaluate before ingestion and 4 to 8 weeks after ingestion. | — |
Countries
Japan
Contacts
Public ContactShingo Yamamichi
EP Mediate Co., Ltd. Development Business Headquarters, TTC Center, Trial Planning Department
Outcome results
None listed