UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034658 |
|---|---|
| Receipt number | R000039513 |
| Scientific Title | A safety evaluation study of excessive intake of the test food (HBF2018-02). |
| Date of disclosure of the study information | 2018/10/28 |
| Last modified on | 2020/01/31 15:38:02 |
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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
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
yuki.ishida@hb.nagase.co.jp
Sponsor or person
Institute
Oneness Support Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039513
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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