Adult
Conditions
Interventions
Enzymolyzed Honeybee Larvae Intake:3,600 mg Ingesion:28 day
Sponsors
Yamada Bee Company, Inc. Research & Development department Institute for Bee Products & Health Science
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 aged more than 20 years, less than 45 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: 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 a history of cerebrovascular disorder.(Excluding asymptomatic lacunar infarct) 4. Have a medical history of 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 "Enzymolyzed Honeybee Larvae".). | — |
Countries
Japan
Contacts
Public ContactToshihito Hiraoka
Yamada Bee Company, Inc. Research & Development department
Outcome results
None listed