UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061869 |
|---|---|
| Receipt number | R000070763 |
| Scientific Title | A cross-sectional study on the continuous consumption of royal jelly and/or propolis and health status |
| Date of disclosure of the study information | 2026/06/11 |
| Last modified on | 2026/06/11 09:28:08 |
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Basic information
Public title
A cross-sectional study on the continuous consumption of royal jelly and/or propolis and health status
Acronym
A cross-sectional study on the continuous consumption of royal jelly and/or propolis and health status
Scientific Title
A cross-sectional study on the continuous consumption of royal jelly and/or propolis and health status
Scientific Title:Acronym
A cross-sectional study on the continuous consumption of royal jelly and/or propolis and health status
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between the long-term consumption of royal jelly and/or propolis and health status, with a specific focus on frailty and pre-frailty, as well as quality of life.
Basic objectives2
Others
Basic objectives -Others
Exploration of the associations with health status and quality of life (QOL).
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence or absence of a total Kihon Checklist (KCL) score of 4 or higher in the primary analysis population aged 65-74 years.
Key secondary outcomes
Norm-based scores of the SF-12v2 Health Survey Japanese version summary scores (Physical Component Summary, Mental Component Summary, and Role/Social Component Summary) in the secondary analysis population aged 40 years and older.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Men and women aged 40 years and older.
2. Individuals who consume royal jelly products, propolis products, or both, manufactured by Yamada Bee Company, Inc.
Key exclusion criteria
none
Target sample size
7346
Research contact person
Name of lead principal investigator
| 1st name | Ayanori |
| Middle name | |
| Last name | Yamaki |
Organization
Yamada Bee Company, Inc.
Division name
Institute for Bee Products & Health Science, R&D department
Zip code
708-0393
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama, Japan
TEL
0868-54-3825
ay1255@yamada-bee.com
Public contact
Name of contact person
| 1st name | Tomoyo |
| Middle name | |
| Last name | Keishi |
Organization
Yamada Bee Company, Inc.
Division name
Institute for Bee Products & Health Science, R&D department
Zip code
708-0393
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama, Japan
TEL
0868-54-3825
Homepage URL
tk1266@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
irb@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
| 2026 | Year | 06 | Month | 11 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Cross-sectional study
Sampling method: Potential participants who meet the inclusion criteria will be selected from customer base of Yamada Bee Company, Inc.
Survey period: From June 15, 2026, to July 31, 2026
Management information
Registered date
| 2026 | Year | 06 | Month | 11 | Day |
Last modified on
| 2026 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070763
