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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036016
Receipt No. 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

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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
Email 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
Email kobayashi@hc-sys.jp

Sponsor
Institute Healthcare Systems Co., Ltd.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041028

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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