UMIN-CTR Clinical Trial

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	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	1st name Middle name Last name Masakazu Terauchi
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
Email	teragyne@tmd.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Masakazu Terauchi
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
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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	2013 Year 09 Month 09 Day
Date of IRB
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

Other
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://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013882

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