UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042951 |
|---|---|
| Receipt number | R000049034 |
| Scientific Title | A Study to Evaluate the Effect of Enzyme-treated Royal Jelly Consumption on the Index of Hematopoietic Stem Cell Count in Healthy Subjects |
| Date of disclosure of the study information | 2021/06/30 |
| Last modified on | 2021/03/24 08:55:34 |
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Basic information
Public title
A Study to Evaluate the Effect of Enzyme-treated Royal Jelly Consumption on the Index of Hematopoietic Stem Cell Count in Healthy Subjects
Acronym
A Study to Evaluate the Effect of Enzyme-treated Royal Jelly Consumption on the Index of Hematopoietic Stem Cell Count in Healthy Subjects
Scientific Title
A Study to Evaluate the Effect of Enzyme-treated Royal Jelly Consumption on the Index of Hematopoietic Stem Cell Count in Healthy Subjects
Scientific Title:Acronym
A Study to Evaluate the Effect of Enzyme-treated Royal Jelly Consumption on the Index of Hematopoietic Stem Cell Count in Healthy Subjects
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The test object will be ingested by healthy adults over a period of four weeks, and the effect on the number of hematopoietic stem cells in the peripheral blood will be examined.
To analyze the effect of enzyme-treated royal jelly on the number of hematopoietic stem cells in the peripheral blood
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hematopoietic stem cell count (CD34+CD45dim cells)
Key secondary outcomes
Endothelial stem cell count (CD34+CD45-CD157+ cells), Endothelial progenitor cell count (CD31+CD34+CD45- cells)
Serum cytokines (CXCL12 and M-CSF)
Hematological examination (WBC, NEU, EOS, BAS, MON, RBC and PLT)
B cell count (CD19+ cells), NK cell count (CD56+ cells), CD4+ T cell count, CD8+ T cell count and CD8+CD28+ T cell count
Questionnaire evaluation (Chalder Fatigue Scale, Pittsburgh Sleep Questionnaire, and other 13-item VAS evaluation)
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:2368.8 mg
Ingesion:28 day
Interventions/Control_2
Placebo food
Intake:2368.8 mg
Ingesion:28 day
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Healthy males and females who are at least 20 years old at the time of obtaining consent
2) Those who can understand and comply with the administration during the study.
3) Those who have obtained written consent of their own free will to participate in the study after fully understanding the contents of the study.
4) Those who are deemed eligible by the study physician and others based on their overall judgment.
Key exclusion criteria
1) Subjects with a history of food allergy
2) Subjects with a history of asthma
3) Pregnant women, those who wish to become pregnant, and those who are breast-feeding
4) Those who have participated in other clinical studies within 12 weeks prior to the intake of the test food.
5) Those with a history of major surgery in the gastrointestinal tract, such as gastrectomy, gastrointestinal suture, or intestinal resection (appendicectomy is acceptable)
6) Subjects suffering from serious hepatic disorder, renal/cardiac disease, organ disorder, diabetes, autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, or other serious disease
7) Those who are receiving medication (hospital visits or medication prescriptions)
8) Those who are unable to consume test foods as instructed or are unable to maintain rest until the end of the test.
9) Those who are unable to prohibit the daily intake of foods that may affect the test.
10) Those who are unable to maintain a regular lifestyle
11) Those who do not work day shifts (night shifts or rotating shifts)
12) Those who have had blood drawn (e.g., donated blood) in excess of 200 mL within 4 weeks prior to the start of this study or 400 mL within 3 months
13) Those whose normal alcohol consumption exceeds 500 mL of beer equivalent per day.
14) Smokers
15) Subjects with a BMI of less than 18.5 and more than 30 kg/m2 (during the study period)
16) Those who cannot follow the instructions to wear a mask when visiting the hospital
17) Those who have cold symptoms such as fever, taste or smell disorder within 1 week of each observation point
18) Those who have had contact with COVID-19 patients or close contacts within 2 weeks of each observation point
19) Persons who have traveled to or had contact with foreign countries within 2 weeks of each observation point.
20) Other persons who are judged by the investigator to be inappropriate for participation in this study.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Nobuaki |
| Middle name | |
| Last name | Okumura |
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
no1780@yamada-bee.com
Public contact
Name of contact person
| 1st name | Hideto |
| Middle name | |
| Last name | Okamoto |
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
Homepage URL
ho1993@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)
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
| 2021 | Year | 06 | Month | 30 | 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
| 2020 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 08 | Day |
Last modified on
| 2021 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049034
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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