UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028707 |
|---|---|
| Receipt number | R000032864 |
| Scientific Title | The study to investigate the living body control function of "Koiaona", which is a cultivar of the kale highly including carotenoids and glucosinolates : a randomized, double-blinded, placebo-controlled trial. |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2019/08/20 09:31:43 |
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Basic information
Public title
The study to investigate the living body control function of "Koiaona", which is a cultivar of the kale highly including carotenoids and glucosinolates : a randomized, double-blinded, placebo-controlled trial.
Acronym
The study of living body control function by "Koiaona".
Scientific Title
The study to investigate the living body control function of "Koiaona", which is a cultivar of the kale highly including carotenoids and glucosinolates : a randomized, double-blinded, placebo-controlled trial.
Scientific Title:Acronym
The study of living body control function by "Koiaona".
Region
| Japan |
Condition
Condition
N/A(healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To verify the living body control function by the carotenoids and glucosinolate intake, in particular the effectiveness to lipid metabolism.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Biomarkers of blood lipids such as LDL-C, HDL-C and TG will be measured as primary endpoint. The changes will be compared within each group and between the treatment groups.
Key secondary outcomes
As secondary endpoints, following items will be evaluated; blood examination involving oxidative stress and special items such as s-LOX1, carotenoid, inflammation, mitochondrial function index, urinalysis, physiological parameters, variety and ratio of bacteria in stool and meal nourishment.
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
Duration: 12 weeks
Test material:"Koiaona " powder
Dose: Take one package, two times a day
Administration: Take one package before breakfast and dinner
Interventions/Control_2
Duration: 12 weeks
Test material:Placebo
Dose: Take one package, two times a day
Administration: Take one package before breakfast and dinner
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)20yrs<=age<=65yrs
2)Male and Female
3)Outpatients
4)120mg/dl<=LDL-Cholesterol<=159mg/dl
5)Those who are able to take the test foods during 3 months.
6)Those who don't change living habits such as exercise, diet, sleeping etc during the study period
7)consent document
Key exclusion criteria
1) Smokers
2)Those who are taking drugs for disease treatment
3) 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]
4) Those who have participated in other clinical trials within before consent get one month,
and those who are currently participating in other clinical trials.
5) 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
6) Those who take antibiotics within before consent get one month
7) Those who currently take health foods
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Naito |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
602-8566
Address
Kajii-cho,Kawaramachi-Hirokoji,Kamigyo-ku,Kyoto 602-8566,JAPAN.
TEL
075-251-5519
ynaito@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Tomohisa |
| Middle name | |
| Last name | Takagi |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
602-8566
Address
Kajii-cho,Kawaramachi-Hirokoji,Kamigyo-ku,Kyoto 602-8566,JAPAN.
TEL
075-251-5508
Homepage URL
takatomo@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University Of Medicine
Institute
Department
Personal name
Funding Source
Organization
R&D matching funds on the field for Knowledge Integration and innovation
Organization
Division
Category of Funding Organization
Other
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
| 2018 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished
Number of participants that the trial has enrolled
43
Results
Unpublished
Results date posted
| 2019 | Year | 08 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Unpublished
Participant flow
Unpublished
Adverse events
Unpublished
Outcome measures
Unpublished
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 17 | Day |
Last modified on
| 2019 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032864
