UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044534 |
|---|---|
| Receipt number | R000050878 |
| Scientific Title | Experimental study on the effects of the test food on the intestinal microenvironment |
| Date of disclosure of the study information | 2021/06/21 |
| Last modified on | 2021/12/03 14:19:17 |
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Basic information
Public title
Experimental study on the effects of the test food on the intestinal microenvironment
Acronym
Experimental study on the effects of the test food on the intestinal microenvironment
Scientific Title
Experimental study on the effects of the test food on the intestinal microenvironment
Scientific Title:Acronym
Experimental study on the effects of the test food on the intestinal microenvironment
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The verify effect on the intestinal microenvironment when taken the test food continuously for four weeks by Japanese men and women aged 20 to 60 years.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire on defecation
Key secondary outcomes
Stool exams at the beginning of the test or after ingestion of four weeks.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake 500ml of the test food for 4 weeks.
Interventions/Control_2
Intake 500ml of the placebo food for 4 weeks.
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
| 60 | 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 60 years old
3.Persons whose stool frequency is 2-4 times per week
Key exclusion criteria
1.Persons who have chronic illness, receiving medication, have a serious disease history.
2.Persons who are allergic to the food.
3.Persons who regularly take large amounts of the test food.
4.Persons who dislike the test food.
5.Persons who regularly take medicines, specified health foods, health foods, supplements, fermented foods (e.g., yogurt, natto, beverage containing lactic acid bacteria).
6.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.
7.Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding.
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
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
ishikawa@hc-sys.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Yoshida |
Organization
Macromill, Inc.
Division name
Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower. 11F, 2-16-1 Konan, Minato-ku, Tokyo, JAPAN
TEL
03-6716-0700
Homepage URL
koh_yoshida@macromill.com
Sponsor or person
Institute
Macromill, Inc.
Institute
Department
Personal name
Funding Source
Organization
Macromill, Inc.
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 | 06 | Month | 21 | 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
30
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 | 06 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 11 | 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 | 06 | Month | 14 | Day |
Last modified on
| 2021 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050878
