UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036249 |
|---|---|
| Receipt number | R000041287 |
| Scientific Title | Plant Fermented Food "Plant Fermented Extract Powder Z" Safety Confirmation Test |
| Date of disclosure of the study information | 2019/03/18 |
| Last modified on | 2019/03/18 16:44:29 |
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Basic information
Public title
Plant Fermented Food "Plant Fermented Extract Powder Z" Safety Confirmation Test
Acronym
Plant Fermented Food "Plant Fermented Extract Powder Z" Safety Confirmation Test
Scientific Title
Plant Fermented Food "Plant Fermented Extract Powder Z" Safety Confirmation Test
Scientific Title:Acronym
Plant Fermented Food "Plant Fermented Extract Powder Z" Safety Confirmation Test
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Plant Fermented Extract Powder Z Ingest 3 times the daily intake to confirm the safety of the food.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Confirm the following offers from the subject: gastrointestinal disorder, vomiting, stomach discomfort, and feeling of fullness.
Confirm the influence on the liver and kidney by subject's blood test
Subjects take the food for 28 days.
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
The subject takes the food for 28 days. Ingest 1g a day, equivalent to three times the amount of active ingredient 300mg daily, for 28 days. Perform blood tests and questionnaires before and after the test.
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
1)The person who does not take medicine for treatment.
2)The tendency to slight constipation (in a week 2-4 times)
3)The person who does not take bowel movement improvement medicine for examination one month.
4)The person who can do it constantly in live during the test days.
5)The person who was admitted by the judgment of the examination responsibility doctor.
Key exclusion criteria
1)The one with a serious disease.
2)person with a history of digestive disease and digestive surgery
3)The person who can not make life constant during examination
4) The person with allergy for the test food.
5)The person who is pregnant and hopes for the pregnancy during the examination.
6)The person who was not admitted by the judgment of the examination responsibility doctor.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Tanaka |
Organization
Kagawa Nutrition University
Division name
Nutrition Clinic
Zip code
170-8481
Address
3-24-3 Komagome,Toshima-ku, Tokyo. 170-8481
TEL
0339186181
clinic@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Kamachi |
Organization
Kagawa Nutrition University
Division name
Nutrition Clinic
Zip code
1708481
Address
3-24-3 Komagome,Toshima-ku, Tokyo.
TEL
0339186181
Homepage URL
kamachi@eiyo.ac.jp
Sponsor or person
Institute
Kagawa Nutrition University
Institute
Department
Personal name
Funding Source
Organization
International Food Co.Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagawa Nutrition University
Address
3-12-9 Chiyoda, Sakado-shi, Saitama
Tel
0492832131
clinic@eiyo.ac.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
| 2019 | Year | 03 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
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
| 2019 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 18 | Day |
Last modified on
| 2019 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041287
