UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050762 |
|---|---|
| Receipt number | R000057846 |
| Scientific Title | Exploratory study for evaluation index of dietary balance in biological samples by metabolome analysis |
| Date of disclosure of the study information | 2023/04/04 |
| Last modified on | 2023/10/03 09:47:09 |
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Basic information
Public title
Exploratory study for evaluation index of dietary balance in biological samples by metabolome analysis
Acronym
Exploratory study for evaluation index of dietary balance in biological samples by metabolome analysis
Scientific Title
Exploratory study for evaluation index of dietary balance in biological samples by metabolome analysis
Scientific Title:Acronym
Exploratory study for evaluation index of dietary balance in biological samples by metabolome analysis
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A comprehensive search for indicators in biological samples that reflect the dietary balance consumed by adults between 20 and 50 years of age.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dietary content for 3 days and metabolite levels and ratios in urine and blood by metabolome analysis.
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
| 20 | years-old | <= |
Age-upper limit
| 50 | 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 50 years old
Key exclusion criteria
1.Persons who have any chronic illnesses with medication and who have any serious disease histories
2.Persons who regularly use medicines or foods with health claims (foods for specified health use, foods with functional claims and foods with nutritional claims) etc., that may affect Urinary and blood metabolites
3.Persons who were judged as inappropriate for study participant by the principal investigator
4.Persons who are breast-feeding, pregnant and planning or wishing to become pregnant during the study period
5.Persons who are taking antithrombotic or antiplatelet drugs
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Naoko |
| Middle name | |
| Last name | Kimura |
Organization
Healthcare Systems Co., Ltd.
Division name
Research and Development Department
Zip code
466-0058
Address
1-14-18 Shirakane, Showa-ku, Nagoya city, Aichi, JAPAN
TEL
052-734-8885
kimura.naoko@hc-sys.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Kimura |
Organization
Healthcare Systems Co., Ltd.
Division name
Research and Development Department
Zip code
466-0058
Address
1-14-18 Shirakane, Showa-ku, Nagoya city, Aichi, JAPAN
TEL
052-734-8885
Homepage URL
kimura.naoko@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Healthcare Systems Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Human Metabolome Technologies, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18 Shirakane, Showa-ku, Nagoya city, Aichi, JAPAN
Tel
052-734-8885
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
| 2023 | Year | 04 | Month | 04 | 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
22
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 | 02 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A comprehensive search for indicators in biological samples that reflect the dietary balance consumed.
Management information
Registered date
| 2023 | Year | 04 | Month | 04 | Day |
Last modified on
| 2023 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057846
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
