UMIN-CTR Clinical Trial

Basic information
Public title	Intestinal environment improvement test by long-term intake of barley flakes
Acronym	Intestinal environment improvement test by long-term intake of barley flakes
Scientific Title	Intestinal environment improvement test by long-term intake of barley flakes
Scientific Title:Acronym	Intestinal environment improvement test by long-term intake of barley flakes
Region	Japan

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

Objectives
Narrative objectives1	Evaluate the effect on intestinal environment improvement by intake of barley flakes for 4 weeks as a test food.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intestinal environment (urine indoxyl sulfate and creatinine) before and after continuous intake for 4 weeks
Key secondary outcomes	Defecation status

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 50g barley flakes daily for 4 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	65 years-old >
Gender	Male and 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 64 years old 3. Persons who have constipation tendency from the preliminary survey questionnaire
Key exclusion criteria	1. Persons who have chronic illness, receiving medication, have a serious disease history 2. Persons who are allergic to the grain such as barley and wheat 3. Persons who are usually taking large amounts of barley 4. Persons who regularly use medicines, specified insurance foods, health foods, etc. that may affect defecation status 5. 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 6. Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding 7. Persons who were judged as inappropriate for study participants by the principal investigator
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 Department
Zip code	105-0004
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL	0368092722
Email	ishikawa@hc-sys.jp

Public contact
Name of contact person	1st name Konomi Middle name Last name Hoshi
Organization	Healthcare Systems Co., Ltd.
Division name	Product Planning Department
Zip code	105-0004
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL	0368092722
Homepage URL
Email	info@karadacheck.com

Sponsor
Institute	Healthcare Systems Co., Ltd.
Institute
Department

Funding Source
Organization	Nishida barley processing 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	The Ethics Committee of Healthcare Systems Co., Ltd.
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
Tel	0368092722
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 08 Month 17 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	28
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 08 Month 17 Day
Date of IRB	2020 Year 08 Month 17 Day
Anticipated trial start date	2020 Year 08 Month 28 Day
Last follow-up date	2020 Year 12 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 08 Month 17 Day
Last modified on	2021 Year 02 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047264