Adult
Conditions
Interventions
fermented royal jelly Intake : 383.5 mg/day Ingestion : 28day
placebo Ingestion : 28day
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women between the ages of 40 and 65 at the time of obtaining informed consent. 2. Subjects who can understand and comply with the rules written in protocol during clinical study period. 3. Subjects who got adequate explanation about the purpose and details of the examination, have the capacity to consent, voluntarily participate in understanding, and agree to participate in the examination in writing.
Exclusion criteria
Exclusion criteria: 1. Subjects who have current or history of food allergies or asthma. 2. Subjects who have a seasonal or perennial allergies during clinical study period. 3. Subjects who have a history of the surgery considerable in the gastrointestinal tract site, for example, gastrectomy, stomach and intestines suturation, intestinal tract resection and so on. 4. Subjects with a current or history of serious illness, such as diabetes, liver disease, kidney disease, heart disease, and more 5. Subjects who have taken medication treatment or going to receive medication. 6. Subjects who are going to receive vaccination for influenza during clinical study period. 7. Subjects who have a history of salivary gland disease, Sjogren's syndrome, perioral radiation therapy, or whole blood dialysis. 8. Subjects who regularly use dietary supplements and health foods (including foods for specified health uses and foods with functional claims) that may affect immunity. 9. Subjects who can not continue regular life. 10. Subjects who have an irregular habit because of working at night or working under work-shift form. 11. Subjects with smoking habit. 12. Subjects who are going to go abroad during clinical study period. 13. Subjects who have taken the blood sampling either 200 mL within 4 weeks or 400 ml within 3 months at the time of clinical examination of screening. 14. Subjects who are pregnant or breast-feeding, or have the will of pregnancy during the study period. 15. Subjects who are planning to participate and/or had participated in other clinical studies within 3 months prior to the current study. 16. Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| concentration and flow rate of salivary sIgA | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunological test using bloods Questionnaire | — |
Countries
Japan
Contacts
Public ContactKaori Konishi
Yamada Bee Company, Inc. Functional research section, Institute for Bee Products & Health Science, R&D department
Outcome results
None listed