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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014482
Receipt No. R000016847
Scientific Title The verified study to investigate and develop the technological assistance of antimetabolic food focusing on living body control function by carotenoids.
Date of disclosure of the study information 2014/07/05
Last modified on 2014/07/05

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Basic information
Public title The verified study to investigate and develop the technological assistance of antimetabolic food focusing on living body control function by carotenoids.
Acronym The study of living body control function by carotenoids.
Scientific Title The verified study to investigate and develop the technological assistance of antimetabolic food focusing on living body control function by carotenoids.
Scientific Title:Acronym The study of living body control function by carotenoids.
Region
Japan

Condition
Condition metabolic syndrome
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Investigation of the effectiveness to the metabolic syndrome by the carotenoid intake such as the beta-carotene lycopene particularly lipid abnormality and the effectiveness to body fat, internal organs fat.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes In this study, the patients of metabolic syndrome (tendency) are included. Kyo Kurenai and TCL-499 involved drink are used to intake of carotenoids. The period of intake is 8 weeks (60days) and before and after the intake, blood examination involving metaboloam-related item and special items such as s-LOX1, carotenoid, immunity, inflammation, mitochondrial function index, urinalysis, physiological function, measuring visceral fat area, and meal nourishment investigation.
Key secondary outcomes Using blood samples, DNS micro array is performed and based on its data, effective biomarker is screened.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 The vegetables juice which assumes a contrast carrot (low beta-caroten) and contrast cabbage (low beta-caroten)
Interventions/Control_2 The vegetable juice which assumes Kyo Kurenai and contrast cabbage (low beta-caroten)
Interventions/Control_3 The vegetables juice which assumes a contrast carrot (low beta-caroten) and TCL-499
Interventions/Control_4 The vegetable juice which assumes Kyo Kurenai and TCL-499
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
40 years-old <=
Age-upper limit
65 years-old >=
Gender Male
Key inclusion criteria The level of BMI (body mass index) is over 25.0
Key exclusion criteria 1. Who has a serious disease under treatment.
2. Who is taking in pharmaceutical products, a supplement
3. Who participates in other clinical trials within three months before agreement acquisition
Target sample size 28

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomohisa Takagi
Organization Kyoto prefectural university of medicine
Division name Molecular Gastroenterology and Hepatology
Zip code
Address 465 Kajiicho Hirokoji Kawaramachidori Kamigyo-ku Kyoto, Japan
TEL 075-251-5519
Email takatomo@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohisa Takagi
Organization Kyoto prefectural University of Medicine
Division name Molecular Gastroenterology and Hepatology
Zip code
Address 465 Kajiicho Hirokoji, Kawaramachidori, Kamigyo-ku, Kyoto
TEL 075-251-5519
Homepage URL
Email takatomo@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto prefectural university of medicine
Institute
Department

Funding Source
Organization National Agriculture and Food Research Organization
Organization
Division
Category of Funding Organization
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
2014 Year 07 Month 05 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 Open public recruiting
Date of protocol fixation
2014 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 14 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
2014 Year 07 Month 05 Day
Last modified on
2014 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016847

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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