healthy volunteers
Conditions
Interventions
Intake of beverages, which contains Probiotic, Lacticaseibacillus paracasei YIT 9029 (strain Shirota)
Intake of beverages not containing Probiotic (control)
Sponsors
Teikyo University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Depression Self-Rating Scale (Center for Epidemiologic Studies-Depression Scale: CES-D) total score between 12 and 30 points
Exclusion criteria
Exclusion criteria: 1) patients with cardiac, hepatic or renal impairments, hematologic or pulmonary diseases, or with a past history of these illnesses 2) patients who meet the diagnosis of major depressive disorder in DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition), or who are under treatment for psychiatric illnesses at medical institutions 3) patients with the history of substance-related and addictive disorders or feeding and eating disorders 4) people with a history of clinically serious allergies 5) people with suicidal ideas: a score of 2 or more on item 9 of the Beck Depression Inventory 2nd edition (BDI-II) 6) people with intestinal illnesses without organic causes or with a history of such diseases 7) people with dementia or intellectual disability 8) patients with diabetes mellitus or with a history of diabetes mellitus 9) pregnant or possibly pregnant women 10) people who have a history of serious head injuries or central nervous system diseases 11) people with a pacemaker 12) people who are allergic to milk or soy 13) people with lactose intolerance 14) people taking probiotics, drugs for intestinal condition and antibiotics regularly 15) people who the research director or researchers judge do not suit for the candidates for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Indices of the autonomic nervous system function calculated from heart rate variability (RR interval, HF, LF/HF, CVRR, SDNN, RMSSD, NN50, pNN50) | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean activity level, questionnaires (CES-D, STAI, PSQI), sleep EEG (sleep onset latency, percentage of non-REM sleep stage 3, mean sleep cycle, sleep efficiency, delta power value per minute of first sleep cycle), blood tests (inflammatory markers, cortisol), gut bacterial count (Bifidobacterium, Atopobium cluster, and lactobacilli) | — |
Countries
Japan
Contacts
Public ContactHiroshi Kunugi
Teikyo University, Faculty of Medicine Department of Psychiatry and Neuroscience
Outcome results
None listed