Adult
Conditions
Interventions
functional food Intake:45 mg Ingesion:3day
Placebo food Intake:45 mg Ingesion:3day
Sponsors
Yamada Bee Company, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy Japanese men and women between the ages of 20 and 60 at the time of consent. 2) Persons who are not receiving any treatment, whether seasonal, chronic, or sudden, by drugs, therapies, or procedures at the time of SCR. 3) Persons who have fully understood the study and have given their consent in writing of their own free will to participate in the study. 4) Persons whose BMI at the time of SCR is between 18.5 and 30.0. 5) Persons who are able to prohibit excessive exercise during the study period. 6) The person must eat three meals a day during the study period and must be able to prohibit binge eating and drinking. 7) The person must be able to use an appropriate method of contraception during the study period. 8) The person must be able to understand and comply with the study's administrative requirements during the study period. 9) Persons who are deemed eligible by the investigators based on their overall judgment.
Exclusion criteria
Exclusion criteria: 1) Persons with a blood glucose level of 140 mg/dl or higher at any time two hours after a meal at the time of screening 2) Those who are continuously taking dietary supplements or supplements related to immune enhancement 3) Persons with allergic diseases such as rhinitis or atopy 4) Those who work day and night shifts or engage in physical labor such as heavy lifting 5) Those who engage in strenuous exercise (6Mets or more) for more than 3.5 hours per week. 6) Subjects who are undergoing treatment that may affect the study, such as hyposensitization therapy. 7) Subjects with a disease under treatment or a history of a serious disease 8) Patients with a history of food allergy 9) Subjects who are judged to be unsuitable for the study based on the results of the SCR examination or the questionnaire at the time of application for the study. 10) Pregnant or lactating women or those who wish to become pregnant during the study period 11) Subjects who are participating or will participate in other clinical trials within one month of obtaining consent for this study. 12) Persons who are unable to comply with administrative requirements during the study period 13) Persons who smoke (including electronic cigarettes) 14) Persons who are unable to comply with instructions to wear a mask when visiting the clinic 15) Persons who have fever or other cold symptoms or taste or smell disorders within one week of each observation point 16) Persons with a history of contact with COVID-19 patients or persons in close contact with COVID-19 patients within 2 weeks of each observation point 17) Persons who have traveled to foreign countries or had contact with such persons within 2 weeks of each observation point. 18) Any other person who is judged by the investigator to be inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NK cells activity | — |
Countries
Japan
Contacts
Public ContactShiho Ikegami
Yamada Bee Company, Inc. Functional Ingredient research section, Institute for Bee Products & Health Science, R&D department
Outcome results
None listed