Unique ID issued by UMIN | UMIN000029627 |
---|---|
Receipt number | R000033845 |
Scientific Title | Protease digested royal jelly pharmacokinetics study in healthy volunteers. |
Date of disclosure of the study information | 2018/12/31 |
Last modified on | 2021/03/11 09:25:58 |
Protease digested royal jelly pharmacokinetics study in healthy volunteers.
Protease digested royal jelly pharmacokinetics study in healthy volunteers.
Protease digested royal jelly pharmacokinetics study in healthy volunteers.
Protease digested royal jelly pharmacokinetics study in healthy volunteers.
Japan |
Adult
Adult |
Others
NO
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.
Pharmacokinetics
Exploratory
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.
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.)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Protease digested royal jelly
Intake:2,400 mg
Ingesion:1day
20 | years-old | <= |
69 | years-old | >= |
Male and Female
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
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.
30
1st name | Masayuki |
Middle name | |
Last name | Sugimoto |
Medical corporation Koganeibasi Sakura Clinic
Not applicable
184-0005
2-11-25 Sakuramachi, Koganei-city, Tokyo, 184-0005, Japan
042-382-5101
info@kb-clinic.com
1st name | Masayuki |
Middle name | |
Last name | Yamaga |
Yamada Bee Company, Inc.
Institute for Bee Products & Health Science
708-0393
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
0868-54-3825
my1636@yamada-bee.com
Yamada Bee Company, Inc.
Yamada Bee Company, Inc.
Profit organization
Research Center for Immunological Analysis. Inc.
none
Koganeibasi Sakura Clinic Ethics Committee
2-11-25 Sakuramachi, Koganei-city, Tokyo, 184-0005, Japan
042-382-5101
info.food@kb-clinic.com
NO
2018 | Year | 12 | Month | 31 | Day |
Unpublished
Completed
2017 | Year | 10 | Month | 20 | Day |
2017 | Year | 10 | Month | 30 | Day |
2017 | Year | 11 | Month | 01 | Day |
2017 | Year | 12 | Month | 02 | Day |
2017 | Year | 10 | Month | 19 | Day |
2021 | Year | 03 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033845
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |