UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051535 |
|---|---|
| Receipt number | R000058800 |
| Scientific Title | The effects of different beverages on the pharmacokinetics of Brazilian green propolis in healthy volunteers. |
| Date of disclosure of the study information | 2023/07/06 |
| Last modified on | 2023/08/16 17:37:15 |
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Basic information
Public title
The effects of different beverages on the pharmacokinetics of Brazilian green propolis in healthy volunteers.
Acronym
The effects of different beverages on the pharmacokinetics of Brazilian green propolis in healthy volunteers.
Scientific Title
The effects of different beverages on the pharmacokinetics of Brazilian green propolis in healthy volunteers.
Scientific Title:Acronym
The effects of different beverages on the pharmacokinetics of Brazilian green propolis in healthy volunteers.
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of the beverage on the Pharmacokinetics of Brazilian green propolis.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma concentration and the area under the plasma concentration -time curve of propolis components.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Blood samples are collected at 6 time points after Brazilian green propolis ( 360 mg ) ingestion with each of 9 beverages. The experimental periods are separated by at least 72 hours as a washout period.
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
| 45 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy Japanese men and women aged between 20 and 45 at the time of informed consent.
2. BMI:18.5 - 25.0
Key exclusion criteria
1. Subjects who have history of food allergies.
2. Subjects who have history of asthma.
3. Subjects in pregnancy or in nursing.
4. Subjects who had participated in other clinical trial within 12 weeks.
5. Subjects who have a history of the surgery considerable in the gastrointestinal tract site, for example, gastrectomy, gastrointestinal suturing, intestinal resection and so on.
6. Subjects with a current or history of serious illness, such as diabetes, liver disease, kidney diseases, heart diseases, and more.
7. Subjects who have taken medication treatment.
8. Subjects who can not refrain from eating and drinking except for designated meals from the dinner before the examination to the end of the examination.
9. Subjects who can not quit smoking from dinner on the day before the examination to the end of the examination.
10. Subjects who can not take the test food as instructed and can not maintain rest until the end of the study.
11. Subjects who can not prohibit intake of foods, medicines and supplements containing propolis or flavonoid before one week at the start of this study.
12. Subjects who can not continue regular life.
13. Subjects who have an irregular habit because of working at night or working under work-shift form.
14. Subjects who have taken the blood sampling either 200 mL within 4 weeks or 400 mL within 3 months.
15. Subjects who are heavy drinker(>500 mL beer per day).
16. Subjects who are smoking more than 20 cigarettes per day.
17. Subjects who are judged as unsuitable for the current in this study by the study director.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Hiroko |
| Middle name | |
| Last name | Tani |
Organization
Yamada Bee Company, Inc.
Division name
Functional Ingredient research section, Yamada Bee Company Institute for Bee product & Health Science, R&D department.
Zip code
708-0393
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
TEL
0868-54-3825
ht0807@yamada-bee.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Haruna |
Organization
Yamada Bee Company, Inc.
Division name
Yamada Bee Company Institute for Bee product & Health Science, R&D department.
Zip code
708-0393
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
TEL
708-0393
Homepage URL
yh2064@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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamada Bee Company Ethics Committee
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
Tel
0868-54-1199
rt2067@yamada-bee.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
| 2023 | Year | 07 | Month | 06 | 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
8
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
| 2023 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 06 | Day |
Last modified on
| 2023 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058800
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| Registered date | File name |
| Research case data | |
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