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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039225
Receipt No. R000044737
Scientific Title The verification study for improving the intestinal environment: a randomized, double-blind, placebo-controlled, crossover trial
Date of disclosure of the study information 2020/01/22
Last modified on 2020/07/16

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Basic information
Public title The verification study for improving the intestinal environment: a randomized, double-blind, placebo-controlled, crossover trial
Acronym The verification study for improving the intestinal environment
Scientific Title The verification study for improving the intestinal environment: a randomized, double-blind, placebo-controlled, crossover trial
Scientific Title:Acronym The verification study for improving the intestinal environment
Region
Japan

Condition
Condition Healthy Japanese adult people
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the effects of the test food on improving intestinal environment
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1.Bowel movement diary
*Recording about the defecation every day.
Key secondary outcomes 1.The Japanese version of Constipation Assessment Scale MT version (CAS-MT)
*Examination before consuming and at 4 weeks after ingestion.

2.Bristol scale
*Examination before consuming and at 4 weeks after ingestion

3.Dietary assessment method
brief-type self-administered diet history questionnaire (BDHQ)
*Examination before consuming and at 4 weeks after ingestion.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 I. active food 1
II. active food 2
III. placebo food

Duration: 4 weeks
Dose: 1 pack, once a day (4 g)
Administration: Take pack after meal with water, warm water, coffee, apple juice, or etc.

*The intervention sequence is I-II-III.
*Washout period is for 2 weeks and more.
Interventions/Control_2 I. active food 2
II. placebo food
III. active food 1

Duration: 4 weeks
Dose: 1 pack, once a day (4 g)
Administration: Take pack after meal with water, warm water, coffee, apple juice, or etc.

*The intervention sequence is I-II-III.
*Washout period is for 2 weeks and more.
Interventions/Control_3 I. placebo food
II. active food 1
III. active food 2

Duration: 4 weeks
Dose: 1 pack, once a day (4 g)
Administration: Take pack after meal with water, warm water, coffee, apple juice, or etc.

*The intervention sequence is I-II-III.
*Washout period is for 2 weeks and more.
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
40 years-old <=
Age-upper limit
69 years-old >=
Gender Female
Key inclusion criteria 1. Japanese adult female

2. Subjects who defecate three to five times per week
Key exclusion criteria 1. A medical history of malignant tumor, heart failure or myocardial infarction.

2. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus.

3. Subjects who are allergic to the test food related products.
Target sample size 48

Research contact person
Name of lead principal investigator
1st name Motoko
Middle name
Last name OHNISHI
Organization Chubu University
Division name College of Bioscience and Biotechnology
Zip code 487-8501
Address 1200 Matsumoto-cho, Kasugai-city, Aichi, JAPAN
TEL 0568-51-6328
Email mohnishi@isc.chubu.ac.jp

Public contact
Name of contact person
1st name Daiki
Middle name
Last name Suehiro
Organization San-ei Sucrochemical Co., Ltd.
Division name Research and Development Section
Zip code 478-8503
Address 24-5, Kitahama-machi, Chita-city, Aichi, JAPAN
TEL 0562-55-5197
Homepage URL
Email daiki-suehiro@sanei-toka.co.jp

Sponsor
Institute Chubu University
Institute
Department

Funding Source
Organization San-ei Sucrochemical Co., 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 Chubu University Certified Review Board
Address 1200 Matsumoto-cho, Kasugai-city, Aichi, JAPAN
Tel 0568-51-1141
Email ***@isc.chubu.ac.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 中部大学(愛知県)
Chubu University (Aichi)

Other administrative information
Date of disclosure of the study information
2020 Year 01 Month 22 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 20
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 10 Month 18 Day
Date of IRB
2019 Year 10 Month 31 Day
Anticipated trial start date
2019 Year 11 Month 19 Day
Last follow-up date
2020 Year 03 Month 31 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 01 Month 22 Day
Last modified on
2020 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044737

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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