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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040115
Receipt No. R000045739
Scientific Title Research on the intestinal environment improving effects by intake of galacto-oligosaccharide containing beverage
Date of disclosure of the study information 2020/04/09
Last modified on 2020/10/09

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Basic information
Public title Research on the intestinal environment improving effects by intake of galacto-oligosaccharide containing beverage
Acronym Research on the intestinal environment improving effects by intake of galacto-oligosaccharide containing beverage
Scientific Title Research on the intestinal environment improving effects by intake of galacto-oligosaccharide containing beverage
Scientific Title:Acronym Research on the intestinal environment improving effects by intake of galacto-oligosaccharide containing beverage
Region
Japan

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

Objectives
Narrative objectives1 Evaluate the intestinal environment improving effects by intake of galacto-oligosaccharide containing beverage for 4weeks.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Creatinine-corrected urinary indoxyl sulfate levels
Key secondary outcomes Questionnaire
-Defecation status
-Skin status
etc

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 Intake of galacto-oligosaccharide containing beverage 125ml per day for 4 weeks at breakfast.
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
65 years-old >
Gender Female
Key inclusion criteria 1.Persons who received a sufficient 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 Japanese who are 20 years old or more and under 65 years old
3.Persons who have constipation tendencies in the preliminary survey questionnaire
Key exclusion criteria 1.Persons who have chronic illness
2.Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding
3.Persons who are taking medications that affect the intestinal environment, such as probiotics, laxatives, and antibiotics
4.Persons who are taking dietary fiber or lactic acid bacteria-containing supplements that improve the intestinal environment
5.Persons who are allergic to soy and/or apples.
6.Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam
Target sample size 30

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 105-0004
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL 050-3640-3595
Email ishikawa@hc-sys.jp

Public contact
Name of contact person
1st name Miho
Middle name
Last name Matsumoto
Organization Healthcare Systems Co., Ltd.
Division name Sales Planning Department
Zip code 105-0004
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL 050-3640-3595
Homepage URL
Email matsumoto@hc-sys.jp

Sponsor
Institute Healthcare Systems Co., Ltd.
Institute
Department

Funding Source
Organization Taishi Food Inc.
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 soumu@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
2020 Year 04 Month 09 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 30
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
2020 Year 04 Month 02 Day
Date of IRB
2020 Year 04 Month 02 Day
Anticipated trial start date
2020 Year 04 Month 16 Day
Last follow-up date
2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 04 Month 09 Day
Last modified on
2020 Year 10 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045739

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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