Adult
Conditions
Interventions
functional food Intake:4,050 mg Ingesion:28day
Sponsors
Yamada Bee Company, Inc.
Research Center for Immunological Analysis, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Target subjects must satisfy the following selection criteria. 1. Healthy Japanese men and women between the ages of 20 - 65 years old at the time of giving informed consent. 2. A person who, during the screening period, is not using chronic or seasonal drugs or medical equipment, and is not undergoing rehabilitation therapy. 3. A person who has freely given consent and has understood the purpose of the study. 4. BMI:18.5 - 30.0 5. Excessive exercise can prevent a person from participating in the clinical study. 6. A person who can take three meals a day basically and prohibit great intemperance during the clinical study. 7. A person who can conduct contraception by an appropriate way during the clinical study. 8. Participant who understands that clinical visits are mandatory during clinical study period. 9. A person who are considered fit for the enrollment in the clinical study.
Exclusion criteria
Exclusion criteria: The subjects in conflict with any of the following condition are excluded. 1. Have a disorder to absorption, distribution, metabolism, excretion of food, such as digestive tract, liver, kidney, heart and cardiovascular system 2. A person with a history of the surgery considerable in the gastrointestinal tract site, for example, gastrectomy, stomach and intestines suturation, intestinal tract resection and so on. (Excluding polypectomy and appendectomy) 3. A person with cerebrovascular disease or a history of cerebrovascular disorder.(Excluding asymptomatic lacunar infarct) 4. Have or have a history of food allergy or asthma or stones. 5. Persons suspected of being dependent on alcohol or drugs 6. A parson who participated in other clinical trial at resent (past 84 days) 7. A person who has taken the blood sampling 400 mL or 200 mL within 84 days, or platelet apheresis within 14days at the time of starting this trial 8. Pregnant women, those who wish to become pregnant, and those who are breastfeeding. 9. Those with irregular lifestyles due to night work, shift work, etc. 10. A person whose roommate is participating or will be participating in this study 11.Those who fail to comply with the control items during the period of this study 12. Others who are judged by the study investigator to be inappropriate for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We confirm safety by integrating adverse events, physiological examination, hematological examination, blood biochemical examination, and urinalysis (Measuring before and 2, 4week after intake of test food.). | — |
Countries
Japan
Contacts
Public ContactNonobe Shuhei
Yamada Bee Company, Inc. Functional research section, Institute for Bee Products & Health Science, R&D department
Outcome results
None listed