UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018206 |
|---|---|
| Receipt number | 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 | 2024/05/16 16:18:46 |
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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 | Tomohisa |
| Middle name | |
| Last name | Takagi |
Organization
Kyoto Prefectural University Of Medicine
Division name
gastrointestinal medicine
Zip code
602-8566
Address
Kajii-cho,Kawaramachi-Hirokoji,Kamigyo-ku,Kyoto 602-8566,JAPAN.
TEL
075-251-5508
takatomo@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.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
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
KYOTO PREFECTURAL UNIVERSITY OF MEDICINE Ethics committee
Address
Kajii-cho,Kawaramachi-Hirokoji,Kamigyo-ku,Kyoto
Tel
075-251-5508
takatomo@koto.kpu-m.ac.jp
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
| 2024 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021081
