UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053507 |
|---|---|
| Receipt number | R000061009 |
| Scientific Title | Exploratory study of an intervention method using tomato juice to maintain/reduce the risk of disease for healthy people |
| Date of disclosure of the study information | 2024/02/01 |
| Last modified on | 2024/03/13 17:26:39 |
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Basic information
Public title
Exploratory study of an intervention method using tomato juice to maintain/reduce the risk of disease for healthy people
Acronym
Exploratory study of an intervention method using tomato juice to maintain/reduce the risk of disease for healthy people
Scientific Title
Exploratory study of an intervention method using tomato juice to maintain/reduce the risk of disease for healthy people
Scientific Title:Acronym
Exploratory study of an intervention method using tomato juice to maintain/reduce the risk of disease for healthy people
Region
| Japan |
Condition
Condition
CVD / lung cancer / dementia / chronic kidney disease / eye disease
Classification by specialty
| Cardiology | Hematology and clinical oncology | Nephrology |
| Ophthalmology | Neurosurgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore interventions that may maintain/reduce the risk of disease(CVD, lung cancer, dementia, and chronic renal failure) in healthy people, as determined by the FonesVisuas Test.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint of this study will be the variable value of the risk of CVD after 12 weeks of tomato juice consumption.
Key secondary outcomes
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
Consume 1 bottle (approx. 200 ml) of commercial tomato juice every morning for 12 weeks
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who have FonesVisuas test in March 2023 * However, if the number of participants in the study is small, this condition will be eliminated and recruitment will be conducted without it.
Key exclusion criteria
Exclude those who meet any of the following criteria 1-5
(1)Persons who are undergoing or have undergone treatment for lung cancer
(2)Persons diagnosed with dementia
(3)People with systemic lupus erythematosus (SLE)
(4)Pregnant women
(5)Persons who are unable to give their written or electromagnetic consent to participate in the research
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Yasuda |
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
syasuda@cardio.med.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
0227178007
med-kenkyo@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
| 2024 | Year | 02 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 12 | 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 | 02 | Month | 01 | Day |
Last modified on
| 2024 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061009
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
