UMIN-CTR Clinical Trial

Basic information
Public title	A study for safety evaluation of excess consumption of test food.
Acronym	A study for safety evaluation of excess consumption of test food.
Scientific Title	A study for safety evaluation of excess consumption of test food.
Scientific Title:Acronym	A study for safety evaluation of excess consumption of test food.
Region	Japan

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

Objectives
Narrative objectives1	To identify the safety of the test food to consume 5 times more than recommended daily intake
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	conduct examinations and tests at 0 week and at 2 and 4 weeks. Hematology test Blood biochemistry test Urinalysis Blood pressure/pulsation Body weight Doctor's questions Adverse event
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Oral intake of the test foods (5 capsules in a day for 4 weeks)
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	1) Healthy adults aged 20 to 80 years old. 2) Gender: No preference 3) Subjects without smoking habits 4) Subjects who do not have a habit of taking a meal containing a large amount of the tested food 5) Subjects who do not suffer from lifestyle diseases (high blood pressure, diabetes etc.), rheumatism, liver disorders, renal disorders, other chronic diseases 6) Subjects who have no history of treatment of malignant tumor, heart failure, myocardial infarction 7) Subjects who have no history of allergy to test foods / medicines 8) Subjects who do not take medication for Outpatient treatment 9) Subjects who do not regularly use health foods 10) Subjects giving written informed consent
Key exclusion criteria	1) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period 2) Subjects who are participating the other clinical tests. Subjects who participated within 3-month prior to the current study 3) Subjects who do not comply with instructions from the doctor or medical staff 4) Others who have been determined ineligible by investigator
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Naotaka Middle name Last name Hashiya
Organization	Kanyukai clinic
Division name	Head
Zip code	553- 0004
Address	2-12-24 Tamagawa Fukushima-ku,Osaka-shi,Osaka,553-0004,Japan
TEL	06-6444-7788
Email	hashiya@carna-medsalon.jp

Public contact
Name of contact person	1st name Taisuke Middle name Last name Fukaya
Organization	Tashikani Plus Co., Ltd
Division name	CEO
Zip code	530-0041
Address	6F 2-2-27 Tenjinbashi Kita-ku,Osaka-shi,Osaka,530-0041,Japan
TEL	06-6352-6622
Homepage URL
Email	fukaya@tashikani.jp

Sponsor
Institute	Tashikani Plus Co., Ltd
Institute
Department

Funding Source
Organization	non-disclosure
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	Japan Food Evidence Association
Address	7F 2-2-27 Tenjinbashi,Kita-ku,Osaka,530-0041,Japan
Tel	06-6352-6622
Email	info@food-evidence.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	2020 Year 04 Month 04 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	No longer recruiting
Date of protocol fixation	2020 Year 03 Month 10 Day
Date of IRB	2020 Year 03 Month 10 Day
Anticipated trial start date	2020 Year 05 Month 21 Day
Last follow-up date	2020 Year 06 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 04 Month 04 Day
Last modified on	2020 Year 09 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045664

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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