A study to evaluate the effect of intake of Watanabe Oyster DHMBA Jelly on the status of stress and sleep in daily life of healthy adults
- Conditions
- Healthy adult
- Registration Number
- JPRN-UMIN000038468
- Lead Sponsor
- TTC Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 58
Not provided
1)Subjects who routinely use food or medicine containing of DHMBA or oyster meat extract 2)Subjects who perform an act for the improvement of the fatigue, stress and the quality of the sleep at least once a week 3)Subjects who are under treatment or a history of mental illness, sleep apnea syndrome, chronic fatigue syndrome, or are strongly suspected 4)Subjects whose score for each scale of BJSQ is "High/Frequent" ("Vigor" is "Low/Infrequent") 5)Subjects who wake after sleep onset more than twice a week for nocturia, children crying at night or other reason 6)Night and day shift worker or manual laborer 7)Subjects who are have treated oral or dental care within the last one month prior to the current study or are planned to treat oral or dental care 8)Subjects who are a history of xerostomia 9)Subjects who has oral or dental problems with bleeding or develops the trouble at least once a week 10)Subjects who are have treated diseases related bowel movements and using drugs, or are regularly using commercially available constipation medicine 11)Subjects who cannot carry out the procedures of various tests to be carried out during this study 12)Subjects who are under treatment or have a history of serious diseases 13)Subjects who has a disease which may influence the outcome of the study 14)Subjects having possibilities for emerging allergy related to the study 15)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination 16)Subjects who are planned to become pregnant or are pregnant or lactating 17)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 18)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire and other questionnaires 19)Subjects who are judged as unsuitable for the study by the investigator for other reason
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Brief Job Stress Questionnaire(BJSQ), OSA sleep inventory MA version
- Secondary Outcome Measures
Name Time Method Profile of Mood States 2nd Edition-Adult Short