N/A (Healthy adults)
Conditions
Interventions
Oral intake of test food once a day for 4 weeks.
Oral intake of placebo food once a day for 4 weeks.
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese healthy males and females of 35 to 59 years age 2. Subjects with fatigue (POMS2 item 26 is 1 or higher and SF-36v2 item 9, "Did you feel tired?", is 3 or lower 3. Subjects giving written informed consent
Exclusion criteria
Exclusion criteria: 1. Subjects with sever systemic diseases affecting the results of this study 2. Subjects who have chronic illness and take medication everyday 3. Subjects who have been drug dependency 4. Subjects who have been taking food containing lactic acid bacteria (e.g. yogurt), health food (e.g. food for specified health use, nutritional functional food, and supplements) regularly for the past month or more 5. Subjects who drink regularly more than 40 g of alcohol (1,000 mL of beer) per day 6. Subjects who can't stop drinking for 2 days before the days of screening and checkup 7. Subjects with no fatigue at all (SF-36v2 item 9, "Were you full of energy?", is 1) 8. Subjects with smoking habits 9. Subjects who have visited a medical facility for the treatment of pollinosis in the past year, or who will probably take prescription medication for the treatment of pollinosis during the study period 10. Subjects who received digestive surgical procedures 11. Subjects who probably have oral or dental problems with bleeding during the study period 12. Subjects who have the plan to receive the influenza vaccine during the study period 13. Subjects with hemoglobin level of 12 g/dl or lower for males and 11 g/dl or lower for females according to the blood test in the screening 14. Subjects who are positive for infectious in the screening 15. Subjects in pregnancy or in nursing 16. Subjects who prone to diarrhea when consuming dairy products 17. Subjects with food allergies 18. Subjects who have participated in other study in the past one month prior to screening, or plan to participate during the test period 19. Subjects who are judged as unsuitable for this study by the investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Activity of dendritic cells | — |
Countries
Japan
Contacts
Public ContactEiji Yoshikawa
KSO Corporation Sales department
Outcome results
None listed