UMIN-CTR Clinical Trial

Basic information
Public title	Protease digested royal jelly pharmacokinetics study in healthy volunteers.
Acronym	Protease digested royal jelly pharmacokinetics study in healthy volunteers.
Scientific Title	Protease digested royal jelly pharmacokinetics study in healthy volunteers.
Scientific Title:Acronym	Protease digested royal jelly pharmacokinetics study in healthy volunteers.
Region	Japan

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

Objectives
Narrative objectives1	We confirm pharmacokinetics of royal jelly metabolites by measuring a blood level of the metabolites before and 0.25, 0.5, 1, 2, 4, 8, 12 h after intake of protease digested royal jelly.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We confirm pharmacokinetics of royal jelly metabolites by measuring a blood level of the metabolites before and 0.25, 0.5, 1, 2, 4, 8, 12 h after intake of protease digested royal jelly.
Key secondary outcomes	We confirm safety by integrating adverse events, physiological examination, hematological examination, blood biochemical examination, and urinalysis. (Measuring before and 12 h after intake of protease digested royal jelly.)

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Protease digested royal jelly Intake:2,400 mg Ingesion:1day
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	69 years-old >=
Gender	Male and Female
Key inclusion criteria	The subjects of the experiment and the Japanese who meet the criteria for all of the following. 1) Healthy japanese 2) Males and females from 20 to 69 years old 3) BMI 18.5-24.9 4) Volunteers who is capable to understand and sign the informed consent
Key exclusion criteria	The subjects in conflict with any of the following condition are excluded. 1) A person who has a food allergy 2) A person who has an asthma 3) A women who is pregnant, hope for the pregnancy, or breastfeeding 4) A parson who participated in other clinical trial at resent (past 3 months) 5) A person who has the infectious disease 6) 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. 7) A person who with the disease to liver, kidney, heart, diabetes and serious desease 8) A person who has received medical treatment of drug now 9) A person who can not visit the designated examination date (including the previous night) and be hospitalized until the trial end. 11) A person who Those who can not quit smoking from dinner the day before the examination to the examination end 12) A person who cannot take in royal jelly according to instruction or cannot maintain rest until the trial end. 13) A person who can not ban the intake of royal jelly-containing food from one week before the clinical trial. 14) A person who cannot keep regular hours 15) A person who is not daily service (who is night or rotation duty) 16) A person who has taken the blood sampling 200 mL within 4 weeks or 400 mL within 3 months at the time of starting this trial 17) A person who is a heavy alcohol drinker (over 500 mL beer per day ) 18) A person who is a heavy smorker (over 20 cigarettes per day) 19) A person who dentified as improper by the principal investigator or subinvestigators.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Masayuki Middle name Last name Sugimoto
Organization	Medical corporation Koganeibasi Sakura Clinic
Division name	Not applicable
Zip code	184-0005
Address	2-11-25 Sakuramachi, Koganei-city, Tokyo, 184-0005, Japan
TEL	042-382-5101
Email	info@kb-clinic.com

Public contact
Name of contact person	1st name Masayuki Middle name Last name Yamaga
Organization	Yamada Bee Company, Inc.
Division name	Institute for Bee Products & Health Science
Zip code	708-0393
Address	194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
TEL	0868-54-3825
Homepage URL
Email	my1636@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)	none

IRB Contact (For public release)
Organization	Koganeibasi Sakura Clinic Ethics Committee
Address	2-11-25 Sakuramachi, Koganei-city, Tokyo, 184-0005, Japan
Tel	042-382-5101
Email	info.food@kb-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	2018 Year 12 Month 31 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	2017 Year 10 Month 20 Day
Date of IRB	2017 Year 10 Month 30 Day
Anticipated trial start date	2017 Year 11 Month 01 Day
Last follow-up date	2017 Year 12 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 10 Month 19 Day
Last modified on	2021 Year 03 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033845