UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050822 |
|---|---|
| Receipt number | R000056713 |
| Scientific Title | A confirmation study of the immunostimulating effect of beekeeping products intake in healthy subjects |
| Date of disclosure of the study information | 2023/04/12 |
| Last modified on | 2023/10/13 09:22:51 |
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Basic information
Public title
A confirmation study of the immunostimulating effect of beekeeping products intake in healthy subjects
Acronym
A confirmation study of the immunostimulating effect of beekeeping products intake in healthy subjects
Scientific Title
A confirmation study of the immunostimulating effect of beekeeping products intake in healthy subjects
Scientific Title:Acronym
A confirmation study of the immunostimulating effect of beekeeping products intake in healthy subjects
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The test objects will be ingested by healthy adults over a 3-day period to determine their effects on immune system indices.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NK cells activity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
functional food
Intake:45 mg
Ingesion:3day
Interventions/Control_2
Placebo food
Intake:45 mg
Ingesion:3day
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Healthy Japanese men and women between the ages of 20 and 60 at the time of consent.
2) Persons who are not receiving any treatment, whether seasonal, chronic, or sudden, by drugs, therapies, or procedures at the time of SCR.
3) Persons who have fully understood the study and have given their consent in writing of their own free will to participate in the study.
4) Persons whose BMI at the time of SCR is between 18.5 and 30.0.
5) Persons who are able to prohibit excessive exercise during the study period.
6) The person must eat three meals a day during the study period and must be able to prohibit binge eating and drinking.
7) The person must be able to use an appropriate method of contraception during the study period.
8) The person must be able to understand and comply with the study's administrative requirements during the study period.
9) Persons who are deemed eligible by the investigators based on their overall judgment.
Key exclusion criteria
1) Persons with a blood glucose level of 140 mg/dl or higher at any time two hours after a meal at the time of screening
2) Those who are continuously taking dietary supplements or supplements related to immune enhancement
3) Persons with allergic diseases such as rhinitis or atopy
4) Those who work day and night shifts or engage in physical labor such as heavy lifting
5) Those who engage in strenuous exercise (6Mets or more) for more than 3.5 hours per week.
6) Subjects who are undergoing treatment that may affect the study, such as hyposensitization therapy.
7) Subjects with a disease under treatment or a history of a serious disease
8) Patients with a history of food allergy
9) Subjects who are judged to be unsuitable for the study based on the results of the SCR examination or the questionnaire at the time of application for the study.
10) Pregnant or lactating women or those who wish to become pregnant during the study period
11) Subjects who are participating or will participate in other clinical trials within one month of obtaining consent for this study.
12) Persons who are unable to comply with administrative requirements during the study period
13) Persons who smoke (including electronic cigarettes)
14) Persons who are unable to comply with instructions to wear a mask when visiting the clinic
15) Persons who have fever or other cold symptoms or taste or smell disorders within one week of each observation point
16) Persons with a history of contact with COVID-19 patients or persons in close contact with COVID-19 patients within 2 weeks of each observation point
17) Persons who have traveled to foreign countries or had contact with such persons within 2 weeks of each observation point.
18) Any other person who is judged by the investigator to be inappropriate to participate in this study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ayanori |
| Middle name | |
| Last name | Yamaki |
Organization
Yamada Bee Company, Inc.
Division name
Functional Ingredient research section, Institute for Bee Products & Health Science, R&D department
Zip code
708-0393
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
TEL
0868-54-3825
ay1255@yamada-bee.com
Public contact
Name of contact person
| 1st name | Shiho |
| Middle name | |
| Last name | Ikegami |
Organization
Yamada Bee Company, Inc.
Division name
Functional Ingredient research section, Institute for Bee Products & Health Science, R&D department
Zip code
708-0393
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
TEL
0868-54-3825
Homepage URL
si1935@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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
shiba_palace@s-palace-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
| 2023 | Year | 04 | Month | 12 | 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
64
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
| 2022 | Year | 11 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | 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 | 04 | Month | 12 | Day |
Last modified on
| 2023 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056713
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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