UMIN-CTR Clinical Trial

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