UMIN-CTR Clinical Trial

Basic information
Public title	Safety evaluation studies of high dose intake of a food aiming for official recognition as a Food with Function Claims.
Acronym	Safety evaluation studies of high dose intake of a food aiming for official recognition as a Food with Function Claims.
Scientific Title	Safety evaluation studies of high dose intake of a food aiming for official recognition as a Food with Function Claims.
Scientific Title:Acronym	Safety evaluation studies of high dose intake of a food aiming for official recognition as a Food with Function Claims.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the safety of excessive ingestion 3-fold quantity of the recommended daily intake of a food aiming for official recognition as a Food with Function Claims.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hematologic test Blood biochemistry test Urine analysis Doctor's questions Adverse events Evaluate after 2 weeks and 4 weeks of ingestion.
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 ingestion of 6 packets of the test food per 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	75 years-old >
Gender	Male and Female
Key inclusion criteria	Healthy adult males and females from 20 to 74years of age
Key exclusion criteria	Individuals meeting any of the following conditions will not be selected as study subjects: 1. Pregnant and nursing mothers 2. Individuals taking medication on a routine basis 3. Individuals with persistent diarrhea. 4. Individuals with a fruit allergy 5. Other individuals deemed unsuitable by the principal investigator.
Target sample size	12

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Prof. Shunji Mizobuchi
Organization	Kochi Medical School, Kochi University
Division name	Clinical Nursing
Zip code
Address	Kohasu, Oko-cho, Nankoku-city, Kochi, Japan
TEL	088-866-5811
Email	mizoshun@kochi-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Shunji Mizobuchi
Organization	Kochi Medical School, Kochi University
Division name	Clinical Nursing
Zip code
Address	Kohasu, Oko-cho, Nankoku-city, Kochi, Japan
TEL	088-866-5811
Homepage URL
Email	mizoshun@kochi-u.ac.jp

Sponsor
Institute	Kochi University
Institute
Department

Funding Source
Organization	Umajimura Agricultural Cooperative MUSE Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 07 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	2018 Year 12 Month 07 Day
Date of IRB	2018 Year 12 Month 04 Day
Anticipated trial start date	2018 Year 12 Month 19 Day
Last follow-up date	2019 Year 03 Month 25 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 12 Month 07 Day
Last modified on	2019 Year 03 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040077