UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035164 |
|---|---|
| Receipt number | R000040077 |
| Scientific Title | 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 | 2019/03/30 14:40:35 |
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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
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
mizoshun@kochi-u.ac.jp
Public contact
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
mizoshun@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040077
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
