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UMIN-CTR Clinical Trial |
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Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000011877 |
Receipt No. | R000013882 |
Scientific Title | Effects of tomato juice on cardiovascular risk markers in middle-aged women |
Date of disclosure of the study information | 2013/09/26 |
Last modified on | 2015/09/26 |
Basic information | ||
Public title | Effects of tomato juice on cardiovascular risk markers in middle-aged women | |
Acronym | Effects of tomato juice on cardiovascular risk markers in middle-aged women | |
Scientific Title | Effects of tomato juice on cardiovascular risk markers in middle-aged women | |
Scientific Title:Acronym | Effects of tomato juice on cardiovascular risk markers in middle-aged women | |
Region |
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Condition | |||
Condition | cardiovascular risk | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To compare the effects of tomato juice on cardiovascular risk markers and heath-related quality of life in middle-aged women |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | cardiovascular risk makers |
Key secondary outcomes |
In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field. |
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 | Treatment | |
Type of intervention |
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Interventions/Control_1 | 8-week treatment with 400 mL/day of tomato juice | |
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 |
In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required. |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Female | |||
Key inclusion criteria | women at cardiovascular risk | |||
Key exclusion criteria | women who have already been treated for hypertension, dyslipidemia, or diabetes | |||
Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Tokyo Medical and Dental University | ||||||
Division name | Department of Women's Health | ||||||
Zip code | |||||||
Address | Yushima 1-5-45, Bunkyo, Tokyo | ||||||
TEL | 03-5803-4605 | ||||||
teragyne@tmd.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Tokyo Medical and Dental University | ||||||
Division name | Department of Women's Health | ||||||
Zip code | |||||||
Address | Yushima 1-5-45, Bunkyo, Tokyo | ||||||
TEL | 03-5803-4605 | ||||||
Homepage URL | |||||||
teragyne@tmd.ac.jp |
Sponsor | |
Institute | Tokyo Medical and Dental University |
Institute | |
Department |
Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one. |
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 | |
Address | |
Tel | |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | http://www.nutritionj.com/content/14/1/34 |
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 | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013882 |