UMIN-CTR Clinical Trial

Basic information
Public title	A safety evaluation study of excessive intake of the test food (HBF2018-02).
Acronym	A safety evaluation study of excessive intake of the test food.
Scientific Title	A safety evaluation study of excessive intake of the test food (HBF2018-02).
Scientific Title:Acronym	A safety evaluation study of excessive intake of the test food.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the safety of the test food.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Inquiry, physical examination, and medical examination by hematology, blood biochemistry, urinalysis.
Key secondary outcomes

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	Four-week repeated intake of food containing the test food.
Interventions/Control_2	Four-week repeated intake of control food not containing the test food.
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1)Healthy males and females aged 20 to 64 years-old. 2)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria	1)Subjects with hepatic, renal, cardiac and/or organ disorders, diabetes, and/or other serious diseases. 2)Subjects with present heart disorder, liver disorder, and/or kidney disorder. 3)Subjects with a disease currently under treatment. 4)Subjects with allergy to the study foods. 5)Subjects with anemia. 6)Subjects who play high intensity sports and/or are on a diet. 7)Subjects who play high intensity sports and/or are on a diet. 8)Subjects who are under treatment with medications (including OTC or prescribed medication). 9)Subjects who drink excessive alcohol, and/or who can't stop drinking from one day before each measurement. 10)Individuals who are a smoker. 11)Subjects who are pregnant, breast-feeding, and/or planning to become pregnant 12)Subjects who are participating in other studies and/or planning to participate during the current study period. 13)Subjects judged as unsuitable for the study by principal investigator for other reasons.
Target sample size	44

Research contact person
Name of lead principal investigator	1st name Naoki Middle name Last name Miura
Organization	Miura Clinic, Medical Corporation Kanonkai
Division name	Internal Medicine
Zip code	530-0044
Address	Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL	06-6135-5200
Email	info@miula.co.jp

Public contact
Name of contact person	1st name Yuki Middle name Last name Ishida
Organization	Hayashibara CO., LTD.
Division name	R&D Division, Development Unit
Zip code	702-8006
Address	675-1, Fujisaki, Naka-ku, Okayama
TEL	086-276-3141
Homepage URL
Email	yuki.ishida@hb.nagase.co.jp

Sponsor
Institute	Oneness Support Co., Ltd.
Institute
Department

Funding Source
Organization	Hayashibara CO., LTD.
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	The Ethics Committee of Miura Clinic, Medical Corporation Kanonkai
Address	Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
Tel	06-6135-5200
Email	mterashima@miura-cl.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	医療法人花音会みうらクリニック（大阪府） / Miura Clinic, Medical Corporation Kanonkai (Osaka)

Other administrative information
Date of disclosure of the study information	2018 Year 10 Month 28 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	44
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	2018 Year 09 Month 19 Day
Date of IRB	2018 Year 09 Month 20 Day
Anticipated trial start date	2018 Year 10 Month 28 Day
Last follow-up date	2019 Year 01 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 10 Month 26 Day
Last modified on	2020 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039513