Adult
Conditions
Interventions
Protease digested royal jelly Intake:2,400 mg Ingesion:1day
Sponsors
Yamada Bee Company, Inc.
Research Center for Immunological Analysis. Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subjects of the experiment and the Japanese who meet the criteria for all of the following. 1) Healthy japanese 2) Males and females from 20 to 69 years old 3) BMI 18.5-24.9 4) Volunteers who is capable to understand and sign the informed consent
Exclusion criteria
Exclusion criteria: The subjects in conflict with any of the following condition are excluded. 1) A person who has a food allergy 2) A person who has an asthma 3) A women who is pregnant, hope for the pregnancy, or breastfeeding 4) A parson who participated in other clinical trial at resent (past 3 months) 5) A person who has the infectious disease 6) 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. 7) A person who with the disease to liver, kidney, heart, diabetes and serious desease 8) A person who has received medical treatment of drug now 9) A person who can not visit the designated examination date (including the previous night) and be hospitalized until the trial end. 11) A person who Those who can not quit smoking from dinner the day before the examination to the examination end 12) A person who cannot take in royal jelly according to instruction or cannot maintain rest until the trial end. 13) A person who can not ban the intake of royal jelly-containing food from one week before the clinical trial. 14) A person who cannot keep regular hours 15) A person who is not daily service (who is night or rotation duty) 16) A person who has taken the blood sampling 200 mL within 4 weeks or 400 mL within 3 months at the time of starting this trial 17) A person who is a heavy alcohol drinker (over 500 mL beer per day ) 18) A person who is a heavy smorker (over 20 cigarettes per day) 19) A person who dentified as improper by the principal investigator or subinvestigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We confirm pharmacokinetics of royal jelly metabolites by measuring a blood level of the metabolites before and 0.25, 0.5, 1, 2, 4, 8, 12 h after intake of protease digested royal jelly. | — |
Secondary
| Measure | Time frame |
|---|---|
| We confirm safety by integrating adverse events, physiological examination, hematological examination, blood biochemical examination, and urinalysis. (Measuring before and 12 h after intake of protease digested royal jelly.) | — |
Countries
Japan
Contacts
Public ContactMasayuki Yamaga
Yamada Bee Company, Inc. Institute for Bee Products & Health Science
Outcome results
None listed