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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034833
Receipt No. R000039726
Official scientific title of the study Exploratory test on the influence of Frugra(R) intake for two weeks on changes in intestinal environment and amount of salt intake
Date of disclosure of the study information 2018/11/09
Last modified on 2018/11/09

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Basic information
Official scientific title of the study Exploratory test on the influence of Frugra(R) intake for two weeks on changes in intestinal environment and amount of salt intake
Title of the study (Brief title) Exploratory test on the influence of Frugra(R) intake on changes in intestinal environment and amount of salt intake
Region
Japan

Condition
Condition Healthy Adults
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Explore the influence of replacement of breakfast with Frugra(R) meal for two weeks on changes in intestinal environment and amount of salt intake before and after ingestion.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Urinary indoxyl sulfate at the beginning of the test or after Frugra(R) ingestion for 2 weeks
Key secondary outcomes Estimated amount of salt intake by spot urine at the beginning of the test or after Frugra(R) ingestion for 2 weeks

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 Replace breakfast with about 50 g of Frugra(R) (Calbee, Inc.) per meal with or without milk or soy milk for two 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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Persons who have had urinary indoxyl sulfate test (trade name: intestinal environmental test "chokatsu check") in Healthcare Systems Co., Ltd. in the past
2.Healthy Japanese who are 20 years old
3.Choose persons whose latest urinary indoxyl sulfate value are higher from the top
Key exclusion criteria 1.Persons who are allergic to the test food
2.Persons who regularly use medicines and quasi-drugs that may affect intestinal environment such as antibiotics
3.Persons who intend to take new supplements during the exam
4.Persons who are breastfeeding, pregnant, scheduled or hoping to be pregnant during the exam period
5.Persons who participated in other examination during the first month before the start of the exam, or those who plan to participate in other exams following this exam agreement
6.Persons who are judged inappropriate for the exam by the principal investigator
Target sample size 30

Research contact person
Name of lead principal investigator Takanori Yasutake
Organization Healthcare Systems Co., Ltd.
Division name Marketing and Sales Promotion Division
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL 03-6809-2722
Email yasutake@hc-sys.jp

Public contact
Name of contact person Takanori Yasutake
Organization Healthcare Systems Co., Ltd.
Division name Marketing and Sales Promotion Division
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL 03-6809-2722
Homepage URL
Email yasutake@hc-sys.jp

Sponsor
Institute Healthcare Systems Co., Ltd.
Institute
Department

Funding Source
Organization Calbee, Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2018 Year 11 Month 09 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 10 Month 22 Day
Anticipated trial start date
2018 Year 11 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 09 Day
Last modified on
2018 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039726

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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