UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050033 |
|---|---|
| Receipt number | R000056999 |
| Scientific Title | Investigation of the effects of test-food intakes on gut environment |
| Date of disclosure of the study information | 2023/01/13 |
| Last modified on | 2023/07/19 14:50:01 |
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Basic information
Public title
Investigation of the effects of test-food intakes on gut environment
Acronym
Investigation of the effects of test-food intakes on gut environment
Scientific Title
Investigation of the effects of test-food intakes on gut environment
Scientific Title:Acronym
Investigation of the effects of test-food intakes on gut environment
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to investigate some kind of effect on gut environment by the test-food ingestion for 12 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation status questionnaire (the number of days, frequency, quantity, property, color, feeling of incomplete evacuation, abdominal pain, fecal odor)
Key secondary outcomes
1. Gut microbiota
2. Gut metabolites
3. QOL questionnaire
4. Sleep status questionnaire
5. Questionnaire about skin
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
Consumption of the test drink (50 mL per day) every day for 12 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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) At informed consent, male/female subjects aged more than or equal to 20, and less than 80 years old.
(2) Subjects who can show understanding of the study procedures and agreement with participating in the study by written informed consent prior to the study.
Key exclusion criteria
(1)Subjects who have consumed fermented plant beverages and foods containing fermented plant extracts within the last 1 month to the study start, or have a plan to consume it during this study.
(2)Subjects who are regularly consuming foods for specified health uses, foods with function claims, supplements and/or health foods for more than 3 times a week, which would affect the study results.
(3)Subjects who have current medical history/anamnesis of immune-related diseases such as autoimmune diseases or digestive ones.
(4)Pregnant, possibly pregnant, or lactating women.
(5)Subjects who have an allergy to the test food.
(6)Subjects who have been determined ineligible for participation, judging from the principal investigator's opinions.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Shinnosuke |
| Middle name | |
| Last name | Murakami |
Organization
Metagen, Inc.
Division name
Headquarters
Zip code
9970052
Address
246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL
+81-235-64-0330
research@metagen.co.jp
Public contact
Name of contact person
| 1st name | Shinnosuke |
| Middle name | |
| Last name | Murakami |
Organization
Metagen, Inc.
Division name
Headquarters
Zip code
9970052
Address
246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL
+81-235-64-0330
Homepage URL
research@metagen.co.jp
Sponsor or person
Institute
Metagen, Inc.
Institute
Department
Personal name
Funding Source
Organization
ARSOA KEIO GROUP CORPORATION
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
Institutional Review Board of Pharmaceutical Law Wisdoms
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
Tel
+81-3-6457-4911
master@yakujihou.net
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
| 2023 | Year | 01 | Month | 13 | 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
Completed
Date of protocol fixation
| 2023 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 13 | Day |
Last modified on
| 2023 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056999
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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