UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018346 |
|---|---|
| Receipt number | R000021234 |
| Scientific Title | Effects of tomato juice intake on health parameters in Kuriyama residents |
| Date of disclosure of the study information | 2015/07/18 |
| Last modified on | 2021/07/21 16:31:21 |
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Basic information
Public title
Effects of tomato juice intake on health parameters in Kuriyama residents
Acronym
Effects of tomato juice intake on health parameters in Kuriyama residents
Scientific Title
Effects of tomato juice intake on health parameters in Kuriyama residents
Scientific Title:Acronym
Effects of tomato juice intake on health parameters in Kuriyama residents
Region
| Japan |
Condition
Condition
cardiovascular risk
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of tomato juice intake on health parameters including cardiovascular risk markers in Kuriyama residents
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cardiovascular risk makers
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
the Kuriyama residents who have their health checked
Key exclusion criteria
people who can not keep diarty of tomato juice intake
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Masakazu |
| Middle name | |
| Last name | Terauchi |
Organization
Tokyo Medical and Dental University
Division name
Department of Women's Health
Zip code
113-8510
Address
Yushima 1-5-45, Bunkyo, Tokyo
TEL
03-5803-4605
teragyne@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Masakazu |
| Middle name | |
| Last name | Terauchi |
Organization
Tokyo Medical and Dental University
Division name
Department of Women's Health
Zip code
113-8510
Address
Yushima 1-5-45, Bunkyo, Tokyo
TEL
03-5803-4605
Homepage URL
teragyne@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
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
Tokyo Medical and Dental University
Address
Yushima 1-5-45, Bunkyo, Tokyo
Tel
03-3813-6111
info.bec@tmd.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
| 2015 | Year | 07 | Month | 18 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1002/fsn3.1066
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1002/fsn3.1066
Number of participants that the trial has enrolled
481
Results
BP in 94 participants with untreated prehypertension or hypertension was significantly lowered (systolic BP, 141.2 +- 12.1-137.0 +- 16.3 mmHg, p = 0.003; diastolic BP, 83.3 +- 10.1-80.9 +- 11.1 mmHg, p = 0.012, paired t test). Further, the serum low-density lipoprotein cholesterol (LDL-C) level in 125 participants with untreated dyslipidemia significantly decreased (155.0 +- 23.2-149.9 +- 25.0 mg/dl, p = 0.005, paired t test).
Results date posted
| 2021 | Year | 07 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Four hundred and eighty-one local residents in Kuriyama, Japan
Participant flow
Throughout the year of the study, they were provided with as much unsalted tomato juice as they wanted
Adverse events
none
Outcome measures
blood pressure (BP), serum lipid profile, and glucose tolerance
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 04 | Month | 03 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 28 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
to compare the health parameters before and after 1-year intake of arbitrary amount of unsalted tomato juice
Management information
Registered date
| 2015 | Year | 07 | Month | 17 | Day |
Last modified on
| 2021 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021234
| 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 |
