UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046112 |
|---|---|
| Receipt number | 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 | 2022/05/19 09:47:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
koyama.kana@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052635
