UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042951
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email ho1993@yamada-bee.com

Sponsor
Institute Yamada Bee Company, Inc.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049034

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.