Healthy Japanese
Conditions
Interventions
Duration: 12 weeks Test product: Test food
Duration: 12 weeks Test product: Placebo food
Sponsors
KSO Corporation
Maebashi North Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy Japanese men and women aged 20 years or older and under 65 years old at the time of consent 2) Individuals who are aware that they are susceptible to colds and influenza 3) Individuals who have received a full explanation of the purpose and content of this study, are competent to consent, fully understand the contents, and voluntarily volunteer to participate, and who provide written consent to participate in this study.
Exclusion criteria
Exclusion criteria: 1) Suffering from or currently undergoing treatment for serious diseases such as diabetes, kidney disease, liver disease, or heart disease, thyroid disease, adrenal gland disease, psychiatric disease, autoimmune disease, or other metabolic diseases 2) Chronic diseases and regular medication use 3) Atopic dermatitis, bronchial asthma, or chronic bronchitis 4) Planning to visit a doctor or take prescription medication annually for hay fever or allergic rhinitis 5) History or current history of drug or alcohol dependence 6) History of gastrointestinal disease or gastrointestinal surgery that affects digestion and absorption 7) Unable to stop taking supplements or health foods that may affect their immune system during the study period 8) Smoking habit 9) Excessive alcohol consumption 10) Unable to stop taking alcohol for two days prior to the screening test or any other test 11) Declared a food allergy to any component of the study products 12) Day-night shift workers, late-night workers, workers who work from home, and workers engaged in physical labor such as transporting heavy objects 13) Pregnant, intend to become pregnant during the study period, or breastfeeding 14) Unsuitable for study participation based on the blood test results of the screening test 15) Scheduling to receive vaccinations for infectious diseases from one month prior to the screening test until the end of the 12-week test after the start of intake. 16) Scheduling to travel abroad during the study period. 17) Taken antibiotics within one month prior to the screening test. 18) Drawn or donated more than 200 mL of blood within one month or more than 400 mL within three months prior to the consent date. 19) Currently participating in or intend to participate in the trials involving the intake of other foods or pharmaceuticals, or the application of cosmetics. 20) Judged unsuitable for study participation by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NK cell activity | — |
Secondary
| Measure | Time frame |
|---|---|
| - Changes in NK cell activity - pDC activity and its changes, and the rate of change - Cumulative days with upper respiratory tract infection (URTI) per individual, and cumulative days by severity for each individual - Cumulative score for each symptom of URTI per individual - Cumulative days with URTI symptoms in each group, and cumulative days by severity for each group | — |
Countries
Japan
Contacts
Public ContactYasushi Tanaka
ITO EN, LTD. Central Research Institute
Outcome results
None listed