UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040052 |
|---|---|
| Receipt number | R000045664 |
| Scientific Title | A study for safety evaluation of excess consumption of test food. |
| Date of disclosure of the study information | 2020/04/04 |
| Last modified on | 2021/02/17 09:14:02 |
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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
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
fukaya@tashikani.jp
Sponsor or person
Institute
Tashikani Plus Co., Ltd
Institute
Department
Personal name
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
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
Terminated
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
| 2021 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045664
