UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014482 |
|---|---|
| Receipt number | 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 11:10:10 |
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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
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
takatomo@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto prefectural university of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016847
| Research Plan | |
|---|---|
| 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 |
