Adult
Conditions
Interventions
functional food Intake:11,850 mg Ingesion:28day
Sponsors
Yamada Bee Company, Inc.
Research Center for Immunological Analysis, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese men and women aged more than 20 years 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: 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 a history of cerebrovascular disorder.(Excluding asymptomatic lacunar infarct) 4. Have a medical history of food allergy disease or asthma. 5. A person with hypersensitivity or idiosyncrasy, such as food allergies. 6. Be Suspected alcohol or drug dependence 7. A parson who participated in other clinical trial at resent (past 84 days) 8. 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 11. Have a irregular habit 12. Had participated over the past 3 months, or currently participate in other clinical trials
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 ContactChizuru Homma
Yamada Bee Company, Inc. Functional research section, Institute for Bee Products & Health Science, R&D department
Outcome results
None listed