UMIN-CTR Clinical Trial

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
Email	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
Email	kk2004@yamada-bee.com

Sponsor
Institute	KSO Corporation
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
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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051893