UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049019 |
|---|---|
| Receipt number | R000055854 |
| Scientific Title | Research of relationship between gut/oral microbiota, urinary metabolic components and physical condition / lifestyle |
| Date of disclosure of the study information | 2023/08/31 |
| Last modified on | 2023/09/26 09:30:31 |
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Basic information
Public title
Research of relationship between gut/oral microbiota, urinary metabolic components and physical condition / lifestyle
Acronym
Research of relationship between gut/oral microbiota, urinary metabolic components and physical condition / lifestyle
Scientific Title
Research of relationship between gut/oral microbiota, urinary metabolic components and physical condition / lifestyle
Scientific Title:Acronym
Research of relationship between gut/oral microbiota, urinary metabolic components and physical condition / lifestyle
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To research reelationship between gut/oral microbiota, urinary metabolic components and physical condition / lifestyle
Basic objectives2
Others
Basic objectives -Others
To research reelationship between gut/oral microbiota, urinary metabolic components and physical condition / lifestyle
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
physical condition / lifestyle questionnaire
Key secondary outcomes
gut microbiota
Oral microbiota
urinary metabolic components
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 40 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Healthy Japanese men and women aged between 40 and 69 at the time of obtaining consent to participate in the study
2) Those who have already obtained written consent to participate in MYCODE research
3) Persons who have received a sufficient explanation of the purpose and content of this research, have the ability to consent, and are able to voluntarily apply for participation after having a good understanding of this research and agree to participate in this research.
Key exclusion criteria
1) Persons with irregular lifestyles such as shift work
2) Subjects who continuously take medicines, foods for specified health use, and foods with function claims that improve the intestinal environment (5 days or more a week)
3) Subjects with a history of serious diseases in the intestines and oral cavity
4) Persons who work for alcoholic beverages, beverages, health foods, or food-related companies
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yoneyama |
Organization
DeNA Life Science, Inc
Division name
Representative Director and President
Zip code
150-6101
Address
Shibuya Scramble Square 2 Chome-24-12 Shibuya, Shibuya City, Tokyo
TEL
03-6811-0877
IRB_dls@dena.com
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Matsuda |
Organization
DeNA Life Science, Inc
Division name
MYCODE service Dept
Zip code
150-6101
Address
Shibuya Scramble Square 2 Chome-24-12 Shibuya, Shibuya City, Tokyo
TEL
050-3160-1172
Homepage URL
tatsuya.matsuda@dena.com
Sponsor or person
Institute
DeNA Life Science, Inc
Institute
Department
Personal name
Funding Source
Organization
Asahi Group Foods, 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
DeNA Life Science, Inc. Ethics Review Committee
Address
Shibuya Scramble Square 2 Chome-24-12 Shibuya, Shibuya City, Tokyo
Tel
03-6811-0877
IRB_dls@dena.com
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 | 08 | Month | 31 | 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
| 2022 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To research reelationship between gut/oral microbiota, urinary metabolic components and physical condition / lifestyle
Management information
Registered date
| 2022 | Year | 09 | Month | 26 | Day |
Last modified on
| 2023 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055854
