Unique ID issued by UMIN | UMIN000018206 |
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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 | 2017/07/11 09:14:48 |
The study to investigate the anti-metabolic effect of high-carotenoids and glucosinolates included kale "Koiaona"
Functional evaluation of kela
The study to investigate the anti-metabolic effect of high-carotenoids and glucosinolates included kale "Koiaona"
Functional evaluation of kela
Japan |
Over weight(BMI>=25)
Medicine in general |
Others
YES
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.
Safety,Efficacy
Visceral fat area
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
The subjects take the test food during 3 months.
The subjects take the placebo food during 3 months.
30 | years-old | <= |
65 | years-old | >= |
Male
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
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
40
1st name | |
Middle name | |
Last name | Tomohisa Takagi |
Kyoto Prefectural University Of Medicine
gastrointestinal medicine
Kajii-cho,Kawaramachi-Hirokoji,Kamigyo-ku,Kyoto 602-8566,JAPAN.
075-251-5508
takatomo@koto.kpu-m.ac.jp
1st name | |
Middle name | |
Last name | Satoshi Sakurai |
imeQ CO. Ltd.
CRO division
a vous primus Bld, 2-14-6, nishiwaseda,Shinjuku-ku 169-0075
03-6205-6222
s-sakurai@imeq.co.jp
Kyoto Prefectural University Of Medicine
National Agriculture and Food Research Organization
Japanese Governmental office
NO
2015 | Year | 07 | Month | 15 | Day |
Unpublished
Completed
2015 | Year | 02 | Month | 06 | Day |
2015 | Year | 07 | Month | 16 | Day |
2015 | Year | 07 | Month | 06 | Day |
2017 | Year | 07 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021081
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