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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035164
Receipt No. R000040077
Official scientific title of the study Safety evaluation studies of high dose intake of a food aiming for official recognition as a Food with Function Claims.
Date of disclosure of the study information 2018/12/07
Last modified on 2018/12/07

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Basic information
Official scientific title of the study Safety evaluation studies of high dose intake of a food aiming for official recognition as a Food with Function Claims.
Title of the study (Brief title) 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
Name of lead principal investigator Prof. Shunji Mizobuchi
Organization Kochi Medical School, Kochi University
Division name Clinical Nursing
Address Kohasu, Oko-cho, Nankoku-city, Kochi, Japan
TEL 088-866-5811
Email mizoshun@kochi-u.ac.jp

Public contact
Name of contact person Shunji Mizobuchi
Organization Kochi Medical School, Kochi University
Division name Clinical Nursing
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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 12 Month 07 Day
Anticipated trial start date
2018 Year 12 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 12 Month 07 Day
Last modified on
2018 Year 12 Month 07 Day


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

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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