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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046112
Receipt No. R000052635
Scientific Title Study for influence of long-term intake of test food on improvement in intestinal environment
Date of disclosure of the study information 2021/11/18
Last modified on 2021/11/18

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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 Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Preinitiation
Date of protocol fixation
2021 Year 11 Month 17 Day
Date of IRB
Anticipated trial start date
2021 Year 11 Month 22 Day
Last follow-up date
2021 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
2021 Year 11 Month 18 Day
Last modified on
2021 Year 11 Month 18 Day


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

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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