Adult
Conditions
Interventions
Brazilian Green Propolis containing food(1) Intake: 1,275mg Ingesion:once
Brazilian Green Propolis containing food(2) Intake:1,425mg Ingesion:once
Sponsors
Yamada Bee Company, Inc.
Research Center for Immunological Analysis. Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subjects who meet all of the following criteria are included in this study. 1) Healthy Japanese 2) Males and females from 20 to 45 years old (at the time of consent acquisition) 3) BMI 18.5-25.0 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 previous history of allergy 2) A person who has a previous history of asthma 3) A woman who is pregnant, hope for the pregnancy, or breastfeeding 4) A person who participated in other clinical trial within 12 weeks prior to ingestion of experimental diet 5) A person who has a positive reaction on the trial for infectious disease at screening 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. (not included appendectomy) 7) A person who has a disease of liver, kidney and heart, diabetes and serious desease 8) A person who has received medical treatment of drug 9) A person who can not visit the designated inspection date (including the previous night) and be hospitalized until the end of a trial. 10) A person who can not quit eating and drinking excluding the designated food the day before the trial to the end of a trial. 11) A person who can not quit smoking from dinner the day before the trial to the end of a trial. 12) A person who cannot take in experimental diet according to instruction or cannot maintain rest until the end of a trial. 13) A person who can not ban the intake of propolis containing food within one week prior to the clinical trial. 14) A person who cannot keep regular hours 15) A person who is not daily service (who is night duty or rotating shift) 16) A person who has taken a blood sample (such as blood donation) of more than 200 mL within 4 weeks or more than 400 mL within 3 months prior to the start of this trial 17) A person who is a heavy alcohol drinker (over 500 mL per day in beer) 18) A person who is a heavy smorker (over 20 cigarettes per day) 19) A person who are judged inappropriate as the subject by the principal investigator or subinvestigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We confirm pharmacokinetics of Propolis metabolites by measuring a blood level of the metabolites before and 0.5,1,1.5,2,4,8,12,24 h after intake of Propolis. | — |
Secondary
| Measure | Time frame |
|---|---|
| We confirm safety by integrating adverse events, physiological examination, hematological examination, blood biochemical examination, and urinalysis (Measuring before and 24 h after intake of Propolis.). | — |
Countries
Japan
Contacts
Public ContactHidenori Matsuzaki
Yamada Bee Company, Inc. Institute for Bee Products & Health Science
Outcome results
None listed