UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060031 |
|---|---|
| Receipt number | R000068656 |
| Scientific Title | An exploratory randomized controlled trial comparing changes in blood protein expression levels following vegetable juice or mineral water consumption interventions |
| Date of disclosure of the study information | 2025/12/09 |
| Last modified on | 2025/12/09 21:01:56 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
An exploratory randomized controlled trial comparing changes in blood protein expression levels following vegetable juice or mineral water consumption interventions
Acronym
An exploratory randomized controlled trial comparing changes in blood protein expression levels following vegetable juice or mineral water consumption interventions
Scientific Title
An exploratory randomized controlled trial comparing changes in blood protein expression levels following vegetable juice or mineral water consumption interventions
Scientific Title:Acronym
An exploratory randomized controlled trial comparing changes in blood protein expression levels following vegetable juice or mineral water consumption interventions
Region
| Japan |
Condition
Condition
CVD / lung cancer / dementia / chronic kidney disease / eye disease / prostate cancer
Classification by specialty
| Cardiology | Hematology and clinical oncology | Nephrology |
| Ophthalmology | Urology | Neurosurgery |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study randomly assigned participants to either a vegetable juice intake group or a mineral water intake group, and conducted an exploratory comparison of changes in blood proteins after 12 weeks of intake.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in individual blood protein levels
- Individual values for approximately 7,000 types of blood protein data
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
For 12 weeks, consume one bottle (approximately 200 ml) of commercially available vegetable juice every morning.
Interventions/Control_2
For 12 weeks, consume one bottle (approximately 200 ml) of commercially available mineral water every morning.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals who have previously undergone the Fones Visuas Test and meet the following criteria:
(1) Those for whom the Fones Visuas Test item "Risk of myocardial infarction or stroke within the past 4 years [Type I]" is greater than 2.2% (Risk Level 2 or higher)
Key exclusion criteria
Exclude individuals who meet any of the following criteria:
(1) Individuals for whom written or electronic consent to participate in the study cannot be obtained
(2) Individuals with a history of allergies, such as feeling unwell after consuming vegetable juice, or individuals who dislike vegetable juice and cannot drink it consistently
(3) Individuals who are currently pregnant and receiving care at an obstetrics and gynecology clinic
(4) Individuals receiving regular medication
(5) Individuals deemed unsuitable by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Nochioka |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7153
kotaro.nochioka.d5@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Katsuyuki |
| Middle name | |
| Last name | Nagai |
Organization
Tohoku University Graduate School of Medicine
Division name
Well-being Design Joint Research Chair
Zip code
980-8575
Address
2-1, Seiryo-machi, Aoba-ku, Sendai
TEL
090-1451-5689
Homepage URL
katsuyuki.nagai.e2@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1, Seiryo-machi, Aoba-ku, Sendai
Tel
022-728-4105
ec-med@grp.tohoku.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
| 2025 | Year | 12 | Month | 09 | 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
| 2025 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 09 | Day |
Last modified on
| 2025 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068656
