UMIN-CTR Clinical Trial
| 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 |
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Basic information
Public title
Protease digested royal jelly pharmacokinetics study in healthy volunteers.
Acronym
Protease digested royal jelly pharmacokinetics study in healthy volunteers.
Scientific Title
Protease digested royal jelly pharmacokinetics study in healthy volunteers.
Scientific Title:Acronym
Protease digested royal jelly pharmacokinetics study in healthy volunteers.
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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.
Key secondary outcomes
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.)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Protease digested royal jelly
Intake:2,400 mg
Ingesion:1day
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key 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
Key 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.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Sugimoto |
Organization
Medical corporation Koganeibasi Sakura Clinic
Division name
Not applicable
Zip code
184-0005
Address
2-11-25 Sakuramachi, Koganei-city, Tokyo, 184-0005, Japan
TEL
042-382-5101
info@kb-clinic.com
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Yamaga |
Organization
Yamada Bee Company, Inc.
Division name
Institute for Bee Products & Health Science
Zip code
708-0393
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
TEL
0868-54-3825
Homepage URL
my1636@yamada-bee.com
Sponsor or person
Institute
Yamada Bee Company, Inc.
Institute
Department
Personal name
Funding Source
Organization
Yamada Bee Company, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Research Center for Immunological Analysis. Inc.
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Koganeibasi Sakura Clinic Ethics Committee
Address
2-11-25 Sakuramachi, Koganei-city, Tokyo, 184-0005, Japan
Tel
042-382-5101
info.food@kb-clinic.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 19 | Day |
Last modified on
| 2021 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033845
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