Healthy Adults
Conditions
Interventions
Daily consumption of one bottle of fermentable dietary fiber-containing food (a total of 24 bottles) over the 4-week intervention period. Perform meditation once daily before bedtime as much as possi
Sponsors
Healthcare Systems Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Persons who received a sufficient explanation of the purpose and contents of the study, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document 2.Japanese aged 20 to 49 years at the time of providing informed consent 3.Persons who have concerns regarding sleep and stress
Exclusion criteria
Exclusion criteria: 1.Persons with chronic illnesses receiving medical treatment or having a serious medical history. 2.Persons diagnosed with sleep disorders by a physician, such as sleep apnea syndrome or insomnia. 3.Persons with a history of or current treatment for psychiatric disorders, such as depression or anxiety disorders. 4.Persons taking psychotropic medications, including hypnotics, anxiolytics, or antidepressants. 5.Persons with severe chronic diseases, such as hypertension, diabetes, liver disease, or kidney disease. 6.Persons likely to develop seasonal allergic symptoms that may significantly affect sleep during the study period. 7.Persons whose sleep is disturbed by painful conditions, such as neuralgia or arthritis. 8.Persons working shifts or frequently traveling abroad with significant time zone changes. 9.Persons with a habit of excessive alcohol consumption. 10.Persons with a habit of excessive caffeine intake. 11.Persons with a smoking habit who may be affected by the arousal effects of nicotine. 12.Persons with a habit of strenuous exercise that may significantly affect sleep due to physical fatigue. 13.Persons who regularly practice meditation or have strict sleep habits that are difficult to modify. 14.Persons regularly using medications or health foods that may affect sleep, stress, or immunity. 15.Persons regularly using medications, health foods, or prebiotic or probiotic products that may affect defecation or the intestinal environment. 16.Persons with allergies to the test food. 17.Persons who habitually and actively consume dietary fiber. 18.Persons who have recently experienced or are likely to experience significant mental stress due to life events. 19.Persons with recent (within 1 month) or planned participation in other research. 20.Persons judged ineligible by the principal investigator. 21.Persons who are pregnant, breastfeeding, or planning pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep quality (electroencephalogram and sleep-related questionnaires) at baseline and after 4 weeks of intake. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following items at baseline and after 4 weeks of intake. Various questionnaires regarding stress, defecation status, and skin concerns Salivary total IgA Intestinal microbiota Fecal organic acids (acetic acid, propionic acid, succinic acid, lactic acid, iso-butyric acid, iso-valeric acid, n-butyric acid, n-valeric acid, and formic acid) Cumulative days of cold symptoms | — |
Countries
Japan
Contacts
Public ContactTakamasa Masuda
Healthcare Systems Co., Ltd. Clinical Research Department
Outcome results
None listed