None listed
Conditions
Interventions
Dietary Supplement : Oral intake of 2 capsules of probiotics (NVP-1704, 5.0 X 10^9 CFU/day) with water once a day for eight weeks and Oral intake of 2 capsules of placebo with water once a day for eig
Sponsors
Navipharm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects with = 50 and = 100 in Stress Response Inventory (SRI) 2) Subjects with at least one of the followings ? = 20 and = 45 in Korean-Beck Depression Inventory-II (K-BDI-II) ? = 16 and = 45 in Korean-Beck Anxiety Inventory (K-BAI) 3) Subjects who agree to participate in the study and sign the informed consent before the initiation of the study
Exclusion criteria
Exclusion criteria: 1) Subject under treatment due to alcohol-induced disorder, heart disease, central nervous system disorder, etc. 2) Subjects with schizophrenia or its history 3) Subjects with DSM-V major depression/mental diseases 4) Subjects showing withdrawal syndrome to alcohol or smoking 5) Subjects who has been treated for dementia within 3 months prior to the initiation of the study 6) Subjects who has been treated for depression, stress, or anxiety within 4 weeks prior to the initiation of the study 7) Subjects having acute stress (death of family/imprisonment/divorce/separation/ debt/runaway/deviation/ extramarital affair/business failure/serious disease/remarriage etc.) within 4 weeks prior to the initiation of the study 8) Subjects who took oral corticosteroid or adrenal corticosteroids within 2 weeks prior to the initiation of the study 9) Subjects who took sleeping agents, anorectic agents or antidepressants within 2 weeks prior to the initiation of the study 10) Subjects who took health functional foods related to the improvement of stress or sleep within 2 weeks prior to the initiation of the study 11) Subjects who took drugs related to colon diseases such as IBS or colitis within 2 weeks prior to the initiation of the study 12) Patients with uncontrolled hypertension (= 160/100 mmHg at the measurement after 10-minute rest) 13) Patients with uncontrolled diabetes mellitus (fasting blood glucose = 180 mg/dl or taking newly prescribed or amended medication due to diabetes within 3 months) 14) Subject who TSH = 0.1uU/ml or = 10uU/ml 15) Subjects under treatment or taking drugs for thyroid diseases 16) Subject with Creatinine = 2 X the upper limit of normal 17) Subjects with AST (GOT) or ALT (GPT) = 3 X upper limit of normal 18) Subjects pregnant breast-feeding or having a plan for pregnancy during the study period. 19) Subject who took antibiotics within 2 weeks prior to the initiation of the study 20) Subjects who have been participating in other clinical trials within 1 month prior to the initiation of this study or have a plan to participate in other clinical trial during this human study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stress Response Inventory;Korean-Beck Depression Inventory-II;Korean-Beck Anxiety Inventory | — |
Secondary
| Measure | Time frame |
|---|---|
| Heart Rate Variability;Pittsburgh sleep quality index;Cortisol, ACTH(Adrenocorticotropic hormone);ISI(Insomnia Severity Index);Blood Presure;IL-6, TNF-a;BDNF(Brain-Derived Neurotrophic Factor);Gut bacterial flora | — |
Countries
Korea, Republic of
Contacts
Public ContactHyuk Joo Lee
Seoul National University Bundang Hospital
Outcome results
None listed