UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056722 |
|---|---|
| Receipt number | R000064732 |
| Scientific Title | A Study of the Effects of Bee Product Ingestion on the Activation of Blood pDC - A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study - |
| Date of disclosure of the study information | 2025/01/20 |
| Last modified on | 2025/01/08 15:04:43 |
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Basic information
Public title
A Study of the Effects of Bee Product Ingestion on the Activation of Blood pDC
- A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study -
Acronym
A Study of the Effects of Bee Product Ingestion on the Activation of Blood pDC
Scientific Title
A Study of the Effects of Bee Product Ingestion on the Activation of Blood pDC
- A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study -
Scientific Title:Acronym
A Study of the Effects of Bee Product Ingestion on the Activation of Blood pDC
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the impact of continuous ingestion of the investigational food product for 12 weeks on blood pDC activation in men and women aged 20 to 69.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Expression of cell surface markers (HLA-DR, CD86, CD40, CD80) on peripheral blood pDCs
Key secondary outcomes
IFN-alpha production by PBMC
Expression of cell surface markers (HLA-DR, CD86, CD40, CD80) on peripheral blood cDC1 and cDC2
Self-reported physical health 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
Participants will take three capsules of the test supplement daily after breakfast.
Interventions/Control_2
Participants will take three capsules of the placebo supplement daily after breakfast.
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
1. Healthy men and women aged 20 to 69 years (at the time of consent)
2. BMI less than 30.0 kg/m^2
3. Individuals who perceive themselves as prone to catching colds
4. Individuals who have had a cold in the past 2 years and engage in face-to-face work outside at least 3 days a week
5. Individuals living with family (those living alone are not eligible)
6. Individuals capable of entering electronic diaries via smartphone or PC
7. Individuals who have received sufficient explanation of the study's purpose and content, fully understand it, voluntarily wish to participate, and have given written consent
Key exclusion criteria
1. Individuals with a current or past history of food allergies, asthma, or atopic dermatitis
2. Individuals with seasonal or perennial allergies during the trial period
3. Individuals regularly taking medications or supplements that may affect study outcomes (participation allowed if these medications or supplements can be discontinued after consent)
4. Individuals with a history of major gastrointestinal surgeries such as gastrectomy, gastrointestinal anastomosis, or intestinal resection (appendectomy is allowed)
5. Individuals with severe liver, kidney, heart diseases, organ disorders, diabetes, or other severe conditions
6. Individuals undergoing drug treatment or planning to receive treatment during the trial period (occasional use of painkillers or antihistamines is allowed)
7. Individuals unable to maintain a regular lifestyle during the trial period
8. Non-daytime workers (night shift or rotating shift workers)
9. Individuals who have donated more than 200 mL of blood within 4 weeks or more than 400 mL within 3 months before the trial
10. Smokers (including electronic cigarettes)
11. Pregnant women or those wishing to become pregnant
12. Heavy alcohol drinkers (pure alcohol intake: 40g/day or more)
13. Individuals planning to travel abroad during the trial period
14. Individuals who participated in other clinical trials within the last 3 months
15. Individuals wishing to receive influenza/COVID-19 vaccination during the trial period or within 4 weeks prior to the SCR visit date
16. Individuals considered unsuitable for study participation by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takato |
| Middle name | |
| Last name | Nikaido |
Organization
Yamada Bee Company, Inc.
Division name
Functional 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
tn2381@yamada-bee.com
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
Daiwa Ginza Bld. 3F, 6-2-1, Ginza, Chuo-ku, Tokyo, Japan
TEL
0367045968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd.
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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
0367045968
jimukyoku@imeqrd.co.jp
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
| 2025 | Year | 01 | Month | 20 | 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
| 2024 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 15 | Day |
Last modified on
| 2025 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064732
