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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018206
Receipt No. R000021081
Scientific Title The study to investigate the anti-metabolic effect of high-carotenoids and glucosinolates included kale "Koiaona"
Date of disclosure of the study information 2015/07/15
Last modified on 2017/07/11

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Basic information
Public title The study to investigate the anti-metabolic effect of high-carotenoids and glucosinolates included kale "Koiaona"
Acronym Functional evaluation of kela
Scientific Title The study to investigate the anti-metabolic effect of high-carotenoids and glucosinolates included kale "Koiaona"
Scientific Title:Acronym Functional evaluation of kela
Region
Japan

Condition
Condition Over weight(BMI>=25)
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The purpose of the study is to verify the validity of the metabolic syndrome by glucosinolate,and carotenoids such as beta-carotene,rutein and by and to verify the influence of the dyslipidemia and body fat visceral fat.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visceral fat area
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 The subjects take the test food during 3 months.
Interventions/Control_2 The subjects take the placebo food during 3 months.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
30 years-old <=
Age-upper limit
65 years-old >=
Gender Male
Key inclusion criteria 1)30yrs<=age<=65yrs
2)Male
3)Outpatients
4)BMI>=25
5)Those who are able to take the test foods during 3 months.
6)Those who don't change the diet or exercise regimen during the study period
7)consent document
Key exclusion criteria 1)People corresponding to the following
*LDL-Cholesterol>=180mg/dl
*Systolic blood pressure>=160mmHg
*Diastolic blood pressure>=90mmHg
*Hemoglobin A1c>=6.5%
*Fasting blood glucose>=140mg/dl
2)Smokers
3)People of dyslipidemia treatment during administration
4)serious heart disease(heart failure,myocardial infarction,myocarditis,etc.)liver disease(liver failure symptoms (fulminant hepatitis),patients with cirrhosis of the liver,liver tumor),renal disease(nephrotic syndrome,renal failure (acute and chronic), uremia, merged, etc.hydronephrosis)
5)Patients who took antihypertensive drugs
6)Those who have participated in other clinical trials within before consent get one month,and those who are currently participating in other clinical trials.
7)At the physician's judgment,who it is determined that there is a possibility that either increased risk to the subject,or sufficient data not obtained
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomohisa Takagi
Organization Kyoto Prefectural University Of Medicine
Division name gastrointestinal medicine
Zip code
Address Kajii-cho,Kawaramachi-Hirokoji,Kamigyo-ku,Kyoto 602-8566,JAPAN.
TEL 075-251-5508
Email takatomo@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Sakurai
Organization imeQ CO. Ltd.
Division name CRO division
Zip code
Address a vous primus Bld, 2-14-6, nishiwaseda,Shinjuku-ku 169-0075
TEL 03-6205-6222
Homepage URL
Email s-sakurai@imeq.co.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 Japanese Governmental office
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
2015 Year 07 Month 15 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 Completed
Date of protocol fixation
2015 Year 02 Month 06 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 16 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
2015 Year 07 Month 06 Day
Last modified on
2017 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021081

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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