UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036016 |
|---|---|
| Receipt number | R000041028 |
| Scientific Title | Test on the influence of consecutively intake of "Amaguri Muichaimashita" on intestinal environment |
| Date of disclosure of the study information | 2019/02/26 |
| Last modified on | 2019/08/27 09:26:58 |
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Basic information
Public title
Test on the influence of consecutively intake of "Amaguri Muichaimashita" on intestinal environment
Acronym
Test on the influence of consecutively intake of "Amaguri Muichaimashita" on intestinal environment
Scientific Title
Test on the influence of consecutively intake of "Amaguri Muichaimashita" on intestinal environment
Scientific Title:Acronym
Test on the influence of consecutively intake of "Amaguri Muichaimashita" on intestinal environment
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Test the influence of consecutively intake of "Amaguri Muichaimashita" on intestinal environment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urinary indoxyl sulfate level before and after intaking test foods (Indoxyl sulfate and creatinine)
Key secondary outcomes
Defecation status during the test, questionnaire (about physical condition and skin condition and more) before and after intaking test foods
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingest total 35g of "Amaguri Muichaimashita" /day for two weeks
Interventions/Control_2
Ingest total 70g of "Amaguri Muichaimashita" /day for two weeks
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
| 30 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
1.Those who received a enough explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2.Healthy women who are 20 years old or more and less than 50 years old
3.Those who defecate three to four times per week from when they agree to participate in this test to two weeks before.
4.Those who have confident to keep eating the test food "Amaguri Muichaimashita" for two weeks.
Key exclusion criteria
1.Those who have chronic disease and is undergoing medication treatment, has a serious disease history
2.Those who is using health foods, supplements, medicines that affect test results
3.Those who are allergic to the test food
4.Those who have participated in other examination during the first month before the start of the exam, or who plan to participate in other exams after consent to this exam
5.Those who were judged inappropriate as subject by the principle investigator
6.Those who are breast-feeding, pregnant, planning or hoping to be pregnant during the test period
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hirohito |
| Middle name | |
| Last name | Ishikawa |
Organization
Healthcare Systems Co., Ltd.
Division name
Research and Development
Zip code
1050004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
ishikawa@hc-sys.jp
Public contact
Name of contact person
| 1st name | Yukari |
| Middle name | |
| Last name | Kobayashi |
Organization
Healthcare Systems Co., Ltd.
Division name
Sales Planning Department
Zip code
1050004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
Homepage URL
kobayashi@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kracie Foods, 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 Healthcare Systems Co., Ltd.
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
Tel
03-6809-2722
kakehashi@hc-sys.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 | 02 | Month | 26 | 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
50
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 | 02 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 04 | 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
| 2019 | Year | 02 | Month | 26 | Day |
Last modified on
| 2019 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041028
