UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050561 |
|---|---|
| Receipt number | R000057574 |
| Scientific Title | Intestinal microbiota analysis and dietary survey research for healthy subjects in middle age |
| Date of disclosure of the study information | 2023/03/10 |
| Last modified on | 2024/09/10 18:06:53 |
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Basic information
Public title
Intestinal microbiota analysis and dietary survey research for healthy subjects in middle age
Acronym
Intestinal microbiota analysis and dietary survey research for healthy subjects in middle age
Scientific Title
Intestinal microbiota analysis and dietary survey research for healthy subjects in middle age
Scientific Title:Acronym
Intestinal microbiota analysis and dietary survey research for healthy subjects in middle age
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to clarify the intestinal microbiota and diet of healthy adult in middle age.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Diet
Key secondary outcomes
1)Intestinal microbiota
2)Diet(calorie intake, nutritional balance, etc)
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A recent HbA1c level of 5.5% or less (within the past month) at the start of this survey
Key exclusion criteria
Those who have the following diseases as current disease history and past history
diabetes, inflammatory bowel disease, Crohn's disease, irritable bowel syndrome, ulcerative colitis, asthma, allergies, rheumatism, autism, dementia, depression, mental illness, multiple sclerosis, autoimmune disease, cancer , liver disease, endocrine disease, chronic kidney disease, chronic renal failure, arteriosclerosis, dyslipidemia, hypertension
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Takatoshi |
| Middle name | |
| Last name | Kato |
Organization
Hokkaido University
Division name
Office of Diversity, Equity, and Inclusion
Zip code
060-0812
Address
Kita 12, Nishi 7, Kita-ku, Sapporo Hokkaido 060-0812, JAPAN
TEL
011-706-3625
kato@dei.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Takatoshi |
| Middle name | |
| Last name | Kato |
Organization
Hokkaido University
Division name
Office of Diversity, Equity, and Inclusion
Zip code
060-0812
Address
Kita 12, Nishi 7, Kita-ku, Sapporo Hokkaido 060-0812, JAPAN
TEL
050-3717-9209
Homepage URL
kato@dei.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Takatoshi Kato
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo University of Health Sciences Research Ethics Committee
Address
4-2-1-15 Nakanuma-nishi, Higashi-ku, Sapporo, Hokkaido 007-0894, JAPAN
Tel
011-792-3350
kato-t@sapporo-hokeniryou-u.ac.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
| 2023 | Year | 03 | Month | 10 | 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
71
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Because the exam is related to another exam that has not yet been completed, and as of now, I am planning to release it simultaneously with that exam.
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 11 | Day |
Date of closure to data entry
| 2023 | Year | 07 | Month | 11 | Day |
Date trial data considered complete
| 2023 | Year | 08 | Month | 11 | Day |
Date analysis concluded
| 2023 | Year | 09 | Month | 11 | Day |
Other
Other related information
The study design is an observational study (cross-sectional study).
From January to June 2023, the research subjects will use the Internet such as newspaper insert flyers, radio commercials, and websites, set up event booths on the promenade in front om the station, distribute flyers near commercial facilities in front of the station, Those who meet the selection criteria and consent to the explanation of the research.
The contents of the survey include basic attributes, dietary habits, exercise habits, diversity and composition of intestinal microbiota.
The results of this study will serve as a basis for use in UMIN study ID UMIN000050560 (receipt number R000057573).
Management information
Registered date
| 2023 | Year | 03 | Month | 10 | Day |
Last modified on
| 2024 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057574
