Healthy subjects who are stressed and have problems such as fatigue (Non-chronic, non-illness)
Conditions
Interventions
Oral intake of the test foods (6 capsules in a day for 8 weeks)
Oral intake of the placebo foods (6 capsules in a day for 8 weeks)
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Japanese healthy adults aged 20 to 65 years old who are stressed 2.Those who get a detailed briefing on this project in advance, can understand the contents, agree with its purpose, and can submit a written consent 3.Subjects who are judged as suitable for the study
Exclusion criteria
Exclusion criteria: 1.Individuals who are, or are under treatment or have a history of serious disease or/and thyroid gland disease, adrenal gland disease, and/or metabolic disorder 2.Subjects who have a disease on treatment or are judged to that medical treatment are necessary by the doctor 3.Subjects who are unable to stop eating foods containing live bacteria during the research period 4.Subjects who has taken health foods, supplements, or drugs that may affect fatigue relief 5.Night and day shift worker or manual laborer 6.Subject who score of Beck Depression Inventory is 20 points or more 7.Subjects diagnosed with chronic fatigue syndrome 8.Subjects who are under treatment or a history of mental illness, sleep apnea syndrome, chronic fatigue syndrome 9.Subjects with VAS of 0 mm 10.Subjects who are unable to stop drinking from 2 days before each test 11.Subject who smokes regularly om a daily (more than 20 cigarettes per day) 12.Subject who has routinely taken large amounts of drinks containing a lot of caffeine (equivalent to 7 cups of coffee /day or more) 13.Subjects having possibilities for emerging allergy related to the study 14.Subjects who are planned to become pregnant 15.Subject who is judged as an inappropriate candidate according to the screening data 16.Subject who has blood drawn 200mL within the past 1 months or 400mL within the past 3 months from the day of the consent acquisition 17.Subject who has or had a history of either medicine or alcohol dependence syndrome 18.Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study 19.Subjects who are a history of xerostomia 20.Subjects who are judged as unsuitable for the study by the investigator for other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of stress by POMS2 and Visual analog scale questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Salivary IgA 2.Salivary Chromogranin A 3.Salivary sialic acid levels 4.Salivary flow rate 5.Serum BDNF levels 6.Serum sialic acid levels 7.Serum HHV6 levels 8.Serum TGF-B 9.Fecal organic acids 10.Fecal IgA levels 11.Gut microbiota 12.NK cell activity 13.Bowel habit | — |
Countries
Japan
Contacts
Public ContactEiji Yoshikawa
KSO Corporation Sales department
Outcome results
None listed