healthy person
Conditions
Interventions
During the intervention period, Group A (30 participants) will perform a stool sample to measure the intestinal microflora one day before the start of intake (week 0) as a pre-measurement, as well as
Sponsors
Clinical Creative Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Men and women between the ages of 18 and 79 (at the time of obtaining consent) 2.A person whose will can be confirmed 3.Those who have a tendency to insomnia or insomnia symptoms according to the preliminary questionnaire survey.However, those with a high risk of being diagnosed as insomniacs will be excluded.
Exclusion criteria
Exclusion criteria: 1.In particular, those who have been diagnosed with insomnia, sleep apnea, or other sleep disorders and are taking pharmaceuticals such as sleep aids or insomnia medications (including OTC medications as well as prescription drugs) or receiving treatment with CPAP, mouthpieces, etc. 2.Currently receiving treatment (including medication) for any disease 3.In particular, those diagnosed and treated for allergic diseases such as atopic dermatitis, asthma, allergic rhinitis, etc. 4.Those who regularly consume Food for Specified Health Use, Food with Functional Labeling, or other food/beverage with possible functionality. 5.BMI greater than 30 (severely obese) 6.Persons primarily responsible for the care of persons in need of nursing care and infants and toddlers 7.Persons employed in late night work, shift work, or heavy labor 8.Pregnant, lactating, or intending to become pregnant 9.Those who cannot sleep alone on one bedding (futon or bed, etc.) during the examination period. 10.Those who are asked to report their normal bedtime and waking time and who have less than 6 hours of bedtime. 11.Those who are unable to comply with the loose sleep control (going to bed within +-2 hours of the reported bedtime and waking within +-2 hours of the reported waking time) during the examination period, or those who are not sleeping regularly. 12.Persons who cannot avoid drinking alcohol and consuming caffeinated beverages (sencha, black tea, coffee, caffeinated beverages, etc.) after 6:00 p.m. during the EEG measurement period and the day before the measurement period. 13.Consistently consumes more than the appropriate amount of alcohol (an average of approximately 20 g of pure alcohol or less per day*) 14.Those with extremely low activity and exercise during the day Items that cannot be listed in the Exclusion Criteria column are listed in Other Relevant Information.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the relationship between the various parameters of the MIRUDAKE cognitive function assessment application for each subject and the presence or absence of the test food intake. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the daily changes and intervention effects by calculating the average values of each sleep parameter (total sleep time, sleep efficiency, sleep onset latency, mid-wake time, total time and percentage of deep sleep time, etc.) for 3 or 2 nights at weeks 4, 8, and 12 of the B. labrata intake period and placebo intake period, respectively, and to explore the relationship between the intake of B. labrata and sleep.The relationship between the ingestion of Bacillus labrata and sleep will be examined in an exploratory manner. 2. Insomnia tendency and daytime sleepiness data (Athens Insomnia Scale, Epworth Sleepiness Scale Questionnaire), stress and cognitive function assessment will be compared with the results of 4 weeks and 8 and 12 weeks of Labret bacteria and placebo intake to evaluate daily changes and intervention effects.These two points will evaluate the effects of Bacillus labre intake on subjective sleep assessment, stress and cognitive function. | — |
Countries
Japan
Contacts
Public ContactKazuhiro Ohno
Clinical Creative Co., Ltd. Pharmaceutical Development Division
Outcome results
None listed