UMIN-CTR Clinical Trial

Basic information
Public title	Study for influence of long-term intake of test food on improvement in intestinal environment
Acronym	Study for influence of long-term intake of test food on improvement in intestinal environment
Scientific Title	Study for influence of long-term intake of test food on improvement in intestinal environment
Scientific Title:Acronym	Study for influence of long-term intake of test food on improvement in intestinal environment
Region	Japan

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

Objectives
Narrative objectives1	Evaluate the improvement effect of the intestinal environment on 20 to 64 years old adults by intake of gluten-free granola for three weeks
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Creatinine-corrected urinary indoxyl sulfate before and three weeks after ingestion.
Key secondary outcomes	Salivary s-IgA, urinary sodium, urinary creatinine, and questionnaire about stomach conditions before and three weeks after ingestion.

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 100g gluten-free granola daily for three 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.Adults who are 20 years old or more and under 65 years old 3.Persons who eat bread at least 4 times a week for breakfast
Key exclusion criteria	1.Persons who have chronic illness, receiving medication, have a serious disease history 2.Persons who are allergic to the test food 3.Persons who usually take a large amount of cereal food 4.Persons who usually take medicine, specified health food, healthy food that may affect the intestinal environment and salt excretion 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 were judged as inappropriate for study participants by the principal investigator 7.Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding
Target sample size	32

Research contact person
Name of lead principal investigator	1st name Kana Middle name Last name Koyama
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	03-6809-2722
Email	koyama.kana@hc-sys.jp

Public contact
Name of contact person	1st name Kana Middle name Last name Koyama
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	03-6809-2722
Homepage URL
Email	koyama.kana@hc-sys.jp

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	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	2021 Year 11 Month 18 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications	https://livelymuesli.com/column/%e3%82%b0%e3%83%ab%e3%83%86%e3%83%b3%e3%83%95%e3%83%aa%e3%83%bc%e3%8
Number of participants that the trial has enrolled	32
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	2021 Year 11 Month 17 Day
Date of IRB	2021 Year 11 Month 22 Day
Anticipated trial start date	2021 Year 11 Month 22 Day
Last follow-up date	2021 Year 12 Month 13 Day
Date of closure to data entry	2022 Year 01 Month 21 Day
Date trial data considered complete	2022 Year 01 Month 22 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 11 Month 18 Day
Last modified on	2022 Year 05 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052635