UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056227 |
|---|---|
| Receipt number | R000064244 |
| Scientific Title | Exploratory research on dietary content and blood and urine biomarkers for the development of techniques to optimize dietary balance |
| Date of disclosure of the study information | 2024/11/21 |
| Last modified on | 2024/11/21 17:51:32 |
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Basic information
Public title
Exploratory research on dietary content and blood and urine biomarkers for the development of techniques to optimize dietary balance
Acronym
Research to visualize dietary balance
Scientific Title
Exploratory research on dietary content and blood and urine biomarkers for the development of techniques to optimize dietary balance
Scientific Title:Acronym
Research to visualize dietary balance
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploring the relationship between diet and blood and urine biomarkers
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Assessment of the relationship between dietary components such as vegetables, fruits, meat, and salt and their biomarker components in blood and urine
Key secondary outcomes
Items of general biochemical values in blood and urine, intestinal flora, height and weight, body composition, blood pressure, index of vegetable intake status from fingertips by optical skin carotenoid content measuring device, questionnaire on daily vegetable and fruit intake
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
Participants restrict their intake of vegetables, fruits, etc. for two days, and then consume 350 g of vegetables and 200 g of fruits per day for two days.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Individuals must be able to provide free and voluntary written consent to participate in the study.
(2) Healthy Japanese individuals between 20 and 65 years of age at the time of consent.
(3) Those who do not have a serious cerebrovascular, cardiac, hepatic, renal, or gastrointestinal disease, cancer, or infectious disease that requires notification.
(4) Those who understand and can implement the intervention diet and vegetable/fruit non-intake period.
(5) Who can use their smartphones in this study.
Key exclusion criteria
(1) Pregnant or possibly pregnant and lactating women.
(2) People who have a disease for which they are receiving continuous treatment, medication, or lifestyle guidance and who are deemed unsuitable as subjects by the research physician at the institution providing informed consent.
(3) Those receiving continuous medication and dietary guidance from a physician or dietitian.
(4) Current participation in another clinical trial.
(5) Subjects who donated whole blood for less than one month.
(6) Food allergies to vegetables, fruits, or other intervention foods.
(7) Other subjects are deemed inappropriate by the principal investigator of the institution where informed consent is to be provided.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | TOUSEN |
Organization
National Institutes of Biomedical Innovation, Health and Nutrition
Division name
Department of Food Function and Labeling
Zip code
566-0002
Address
Kento Innovation Park, NK Building, 3-17 Senrioka Shinmachi, Settsu-shi, Osaka 566-0002, Japan
TEL
06-6384-1120
tousen@nibiohn.go.jp
Public contact
Name of contact person
| 1st name | Hirohito |
| Middle name | |
| Last name | Ishikawa |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
466-0058
Address
1-14-18 Shirokane, Showa-ku, Nagoya City, Aichi Prefecture
TEL
052-734-8885
Homepage URL
oyama.suzuka@hc-sys.jp
Sponsor or person
Institute
National Institute of Biomedical Innovation, Health and Nutrition
Institute
Department
Personal name
Funding Source
Organization
others
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Healthcare Systems Co., Ltd.
National Agriculture and Food Research Organization
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Review Committee, National Institute of Biomedical Innovation, Health and Nutrition
Address
7-6-8 Asagi, Saito, Ibaraki City, Osaka, Japan
Tel
072-641-9829
irb-office@nibiohn.go.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
国立研究開発法人医薬基盤・健康・栄養研究所 （大阪府）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 21 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 21 | Day |
Last modified on
| 2024 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064244
