UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045450 |
|---|---|
| Receipt number | R000051893 |
| Scientific Title | Evaluation of fermented royal jelly on immune parameters -Placebo-controlled randomized, double-blind study- |
| Date of disclosure of the study information | 2021/09/10 |
| Last modified on | 2022/03/14 08:25:30 |
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Basic information
Public title
Evaluation of fermented royal jelly on immune parameters
-Placebo-controlled randomized, double-blind study-
Acronym
Evaluation of fermented royal jelly on immune parameters
-Placebo-controlled randomized, double-blind study-
Scientific Title
Evaluation of fermented royal jelly on immune parameters
-Placebo-controlled randomized, double-blind study-
Scientific Title:Acronym
Evaluation of fermented royal jelly on immune parameters
-Placebo-controlled randomized, double-blind study-
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the effect of fermented royal jelly for healthy adults on immune parameters including salivary sIgA and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
concentration and flow rate of salivary sIgA
Key secondary outcomes
Immunological test using bloods
Questionnaire
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
fermented royal jelly
Intake : 383.5 mg/day
Ingestion : 28day
Interventions/Control_2
placebo
Ingestion : 28day
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Men and women between the ages of 40 and 65 at the time of obtaining informed consent.
2. Subjects who can understand and comply with the rules written in protocol during clinical study period.
3. Subjects who got adequate explanation about the purpose and details of the examination, have the capacity to consent, voluntarily participate in understanding, and agree to participate in the examination in writing.
Key exclusion criteria
1. Subjects who have current or history of food allergies or asthma.
2. Subjects who have a seasonal or perennial allergies during clinical study period.
3. Subjects who have a history of the surgery considerable in the gastrointestinal tract site, for example, gastrectomy, stomach and intestines suturation, intestinal tract resection and so on.
4. Subjects with a current or history of serious illness, such as diabetes, liver disease, kidney disease, heart disease, and more
5. Subjects who have taken medication treatment or going to receive medication.
6. Subjects who are going to receive vaccination for influenza during clinical study period.
7. Subjects who have a history of salivary gland disease, Sjogren's syndrome, perioral radiation therapy, or whole blood dialysis.
8. Subjects who regularly use dietary supplements and health foods (including foods for specified health uses and foods with functional claims) that may affect immunity.
9. Subjects who can not continue regular life.
10. Subjects who have an irregular habit because of working at night or working under work-shift form.
11. Subjects with smoking habit.
12. Subjects who are going to go abroad during clinical study period.
13. Subjects who have taken the blood sampling either 200 mL within 4 weeks or 400 ml within 3 months at the time of clinical examination of screening.
14. Subjects who are pregnant or breast-feeding, or have the will of pregnancy during the study period.
15. Subjects who are planning to participate and/or had participated in other clinical studies within 3 months prior to the current study.
16. Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0001
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Konishi |
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
TEL
0868-54-3825
Homepage URL
kk2004@yamada-bee.com
Sponsor or person
Institute
KSO Corporation
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
Ethical Committee of Nihonbashi Cardiology Clinic
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel
03-5641-4133
niho-jimucho@well-sleep.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
| 2021 | Year | 09 | Month | 10 | 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
| 2021 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 28 | 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 | 09 | Month | 10 | Day |
Last modified on
| 2022 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051893
