UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047277 |
|---|---|
| Receipt number | R000053917 |
| Scientific Title | An observational study on lifestyle and blood metabolites. (SWE-2021-05-HBKS) |
| Date of disclosure of the study information | 2022/03/27 |
| Last modified on | 2023/04/11 17:58:27 |
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Basic information
Public title
An observational study on lifestyle and blood metabolites.
(SWE-2021-05-HBKS)
Acronym
An observational study on lifestyle and blood metabolites.
Scientific Title
An observational study on lifestyle and blood metabolites.
(SWE-2021-05-HBKS)
Scientific Title:Acronym
An observational study on lifestyle and blood metabolites.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between lifestyle and blood metabolites exploratory.
Basic objectives2
Others
Basic objectives -Others
To investigate the relationship between lifestyle and blood metabolites exploratory.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood metabolites (metabolome, lipidome)
Key secondary outcomes
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Women and men aged 40 to 64 years.
(2) Persons who can understand the purpose and content of this study and agree in writing to participate in this study.
Key exclusion criteria
(1) Persons who ingested specific health foods, foods with functional claims, foods for specified health use, etc. within 2 weeks before the inspection date.
(2) Persons with a BMI of 18.5 or less or 25 or more.
(3) Persons who are or may be taking medications continuously during the study period.
(4) Pregnant (including those who may be pregnant) or lactating.
(5) Others who are judged by the principal investigator to be inappropriate for research.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Takemoto |
Organization
Suntory Wellness Limited
Division name
Institute for Health Care Science
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL
050-3182-0661
Daisuke_Takemoto@suntory.co.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Takemoto |
Organization
Suntory Wellness Limited
Division name
Institute for Health Care Science
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL
050-3182-0661
Homepage URL
Daisuke_Takemoto@suntory.co.jp
Sponsor or person
Institute
Suntory Wellness Limited
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
nakagawa.akiko297@eps.co.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
| 2022 | Year | 03 | Month | 27 | 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 | 03 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate the relationship between lifestyle and blood metabolites exploratory.
Management information
Registered date
| 2022 | Year | 03 | Month | 24 | Day |
Last modified on
| 2023 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053917
