UMIN-CTR Clinical Trial

Basic information
Public title	Safety verification test using a overdose of fermented royal jelly containing food that intended for healthy individuals
Acronym	Safety verification test using a overdose of fermented royal jelly containing food that intended for healthy individuals
Scientific Title	Safety verification test using a overdose of fermented royal jelly containing food that intended for healthy individuals
Scientific Title:Acronym	Safety verification test using a overdose of fermented royal jelly containing food that intended for healthy individuals
Region	Japan

Condition
Condition	Adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will check about safety while people take test food excessively for 4 weeks.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We confirm safety by integrating adverse events, physiological examination, hematological examination, blood biochemical examination, and urinalysis (Measuring before and 2, 4week after intake of test food.).
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	functional food Intake:4,545 mg Ingesion:28days
Interventions/Control_2
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	45 years-old >=
Gender	Male and Female
Key inclusion criteria	Target subjects must satisfy the following selection criteria. 1. Healthy Japanese men and women between the ages of 20 - 45 years old at the time of giving informed consent. 2. A person who, during the screening period, is not using chronic or seasonal drugs or medical equipment, and is not undergoing rehabilitation therapy. 3. A person who has freely given consent and has understood the purpose of the study. 4. BMI:18.5 - 30.0 5. Excessive exercise can prevent a person from participating in the clinical study. 6. A person who can take three meals a day basically and prohibit great intemperance during the clinical study. 7. A person who can conduct contraception by an appropriate way during the clinical study. 8. Participant who understands that clinical visits are mandatory during clinical study period. 9. A person who are considered fit for the enrollment in the clinical study.
Key exclusion criteria	The subjects in conflict with any of the following condition are excluded. 1. Have a disorder to absorption, distribution, metabolism, excretion of food, such as digestive tract, liver, kidney, heart and cardiovascular system 2. A person with a history of the surgery considerable in the gastrointestinal tract site, for example, gastrectomy, stomach and intestines suturation, intestinal tract resection and so on. (Excluding polypectomy and appendectomy) 3. A person with a history of cerebrovascular disorder.(Excluding asymptomatic lacunar infarct) 4. Have a medical history of food allergy disease or asthma. 5. A person with hypersensitivity or idiosyncrasy, such as food allergies. 6. Be Suspected alcohol or drug dependence 7. A parson who participated in other clinical trial at resent (past 84 days) 8. A person who has taken the blood sampling 400 mL or 200 mL within 84 days, or platelet apheresis within 14days at the time of starting this trial 11. Have a irregular habit 12. Had participated over the past 3 months, or currently participate in other clinical trials
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Ayanori Middle name Last name Yamaki
Organization	Yamada Bee Company, Inc.
Division name	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	ay1255@yamada-bee.com

Public contact
Name of contact person	1st name Wakako Middle name Last name Miyamoto
Organization	Yamada Bee Company, Inc.
Division name	Functional Ingredient 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	wm2176@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	Yamada Bee Company Ethics Committee
Address	194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
Tel	0868-54-1199
Email	kk2004@yamada-bee.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 12 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	2021 Year 05 Month 20 Day
Date of IRB	2021 Year 06 Month 02 Day
Anticipated trial start date	2021 Year 06 Month 03 Day
Last follow-up date	2021 Year 08 Month 06 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 05 Month 27 Day
Last modified on	2021 Year 12 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050648