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Recruitment status Completed
Unique ID issued by UMIN UMIN000035670
Receipt No. R000040411
Scientific Title safety verification test using a overdose of the test food "Enzymolyzed Honeybee Larvae" that intended for healthy individuals
Date of disclosure of the study information 2019/06/30
Last modified on 2019/07/29

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Basic information
Public title safety verification test using a overdose of the test food "Enzymolyzed Honeybee Larvae" that intended for healthy individuals
Acronym safety verification test using a dose of the test food "Enzymolyzed Honeybee Larvae" that intended for healthy individuals
Scientific Title safety verification test using a overdose of the test food "Enzymolyzed Honeybee Larvae" that intended for healthy individuals
Scientific Title:Acronym safety verification test using a dose of the test food "Enzymolyzed Honeybee Larvae" that intended for healthy individuals

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

Narrative objectives1 We will check about safety while people take usual "Enzymolyzed Honeybee Larvae" excessively for 4 weeks. We evaluated safety through physical examinations (interviews, auscultation, percussion, inspection, palpation, etc.) and changes in clinical laboratory values from the baseline evaluation (vist0, week0) to the second evaluation (visit2, week 4).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

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 "Enzymolyzed Honeybee Larvae".).
Key secondary outcomes

Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Dynamic allocation
Institution consideration

No. of arms 1
Purpose of intervention Prevention
Type of intervention
Interventions/Control_1 Enzymolyzed Honeybee Larvae
Intake:3,600 mg
Ingesion:28 day

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 aged more than 20 years, less than 45 years 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 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
Middle name
Last name Yuzuri Sato
Organization Medical corporation Koganeibasi Sakura Clinic
Division name Not applicable
Zip code
Address 2-11-25 Sakuramachi, Koganei-city, Tokyo, 184-0005, Japan
TEL 042-382-5252

Public contact
Name of contact person
1st name
Middle name
Last name Toshihito Hiraoka
Organization Yamada Bee Company, Inc.
Division name Research & Development department
Zip code
Address 194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
TEL 0868-54-3825
Homepage URL

Institute Yamada Bee Company, Inc.
Research & Development department
Institute for Bee Products & Health Science

Funding Source
Organization Yamada Bee Company, Inc.
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) none

IRB Contact (For public release)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2

Institutions 医療法人社団翔医会 小金井橋さくらクリニック(東京都)

Other administrative information
Date of disclosure of the study information
2019 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished

URL related to results and publications
Number of participants that the trial has enrolled
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

Recruitment status Completed
Date of protocol fixation
2019 Year 01 Month 07 Day
Date of IRB
2019 Year 01 Month 21 Day
Anticipated trial start date
2019 Year 03 Month 01 Day
Last follow-up date
2019 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other related information

Management information
Registered date
2019 Year 01 Month 25 Day
Last modified on
2019 Year 07 Month 29 Day

Link to view the page

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name

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