Healthy adults
Conditions
Sponsors
Medical Corporation Yutoku Hossinkai
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Those who are dissatisfied or anxious about their sleep. (2)Men and women who are at least 20 years old and less than 65 years old (at the time of consent) at the time of obtaining written consent to participate in the study. (3)Persons who have the necessary comprehension to consent to all tests, observations, and evaluation items specified in the study protocol, and who are able to obtain written consent based on their understanding of the contents of the study. (4)Persons who are deemed appropriate by the investigator to participate in this study.
Exclusion criteria
Exclusion criteria: (1) Those who currently suffer from some chronic disease and are receiving drug treatment. (including psychoneurological disorders) (2)Persons who may show severe allergic symptoms to foods. (3) Those who are pregnant or may become pregnant. (4)Persons who are participating in other human clinical trials or have participated in other human clinical trials within 3 months (5)Persons who consume excessive amounts of alcohol (6)Those who are unable to participate in the study due to hepatic, renal, or cardiac disease, respiratory disorder, endocrine disorder, metabolic disorder, neurological disorder, consciousness disorder, diabetes mellitus, or other diseases. (7) Other subjects who are judged by the investigator to be inappropriate for the study. (8)Those whose working hours vary greatly from day to day.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective sleep assessment (Athens Insomnia Scale (AIS), Pittsburgh Sleep Questionnaire (PSQI)), VAS for fatigue, heart rate analysis during sleep (BITAS-Health care) | — |
Secondary
| Measure | Time frame |
|---|---|
| Psychological assessment of stress (POMS2), urinalysis (general urine analysis, creatinine and 8-OHdG), salivary hormone analysis (cortisol and sIgA), blood tests (common hematology and biochemistry tests) | — |
Countries
Japan
Contacts
Public ContactKatsuyuki Shiono
Algalbio Co., Ltd. Business Development Group
Outcome results
None listed