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Recruitment status Completed
Unique ID issued by UMIN UMIN000011877
Receipt No. R000013882
Official scientific title of the study 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

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Basic information
Official scientific title of the study Effects of tomato juice on cardiovascular risk markers in middle-aged women
Title of the study (Brief title) Effects of tomato juice on cardiovascular risk markers in middle-aged women
Region
Japan

Condition
Condition cardiovascular risk
Classification by specialty
Cardiology Obsterics and gynecology
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
Food
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
40 years-old <=
Age-upper limit
60 years-old >
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 Masakazu Terauchi
Organization Tokyo Medical and Dental University
Division name Department of Women's Health
Address Yushima 1-5-45, Bunkyo, Tokyo
TEL 03-5803-4605
Email teragyne@tmd.ac.jp

Public contact
Name of contact person Masakazu Terauchi
Organization Tokyo Medical and Dental University
Division name Department of Women's Health
Address Yushima 1-5-45, Bunkyo, Tokyo
TEL 03-5803-4605
Homepage URL
Email 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)

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
2013 Year 09 Month 26 Day

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 09 Month 09 Day
Anticipated trial start date
2013 Year 09 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Published
URL releasing results http://www.nutritionj.com/content/14/1/34
Results
Other related information

Management information
Registered date
2013 Year 09 Month 26 Day
Last modified on
2015 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013882


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