UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035929 |
|---|---|
| Receipt number | R000040928 |
| Scientific Title | A verification study for kale "Koiaona" effects on serum uric acid level regulation: a randomized, double-blinded, placebo-controlled trial. |
| Date of disclosure of the study information | 2019/07/15 |
| Last modified on | 2021/02/22 09:29:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A verification study for kale "Koiaona" effects on serum uric acid level regulation: a randomized, double-blinded, placebo-controlled trial.
Acronym
A verification study for "Koiaona" effects on serum uric acid level regulation.
Scientific Title
A verification study for kale "Koiaona" effects on serum uric acid level regulation: a randomized, double-blinded, placebo-controlled trial.
Scientific Title:Acronym
A verification study for "Koiaona" effects on serum uric acid level regulation.
Region
| Japan |
Condition
Condition
N/A(healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects on serum uric acid level reduction by "Koiaona".
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum uric acid level
Key secondary outcomes
Urine dithiocarbamates concentration, Blood carotenoid concentration, Variety and ratio of bacteria in stool, Urine uric acid level / urinary creatinine level ratio.
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
Key inclusion criteria
1)20yrs<=age<=65yrs
2)Male
3)Outpatients
4)6.0 mg/dl<=uric acid level <=7.9 mg/dl
5)Those who don't change living habits such as exercise, diet, etc. during the study period.
6) Those who received a full explanation of the procedures in the study, and informed consent was documented and signed.
Key exclusion criteria
1) Those who are receiving medication and/or treatment such as hyperuricemia or gout.
2) Those who are under treatment of diseases (urinary stone, kidney stone, rheumatoid arthritis) which may influence the outcome of the study, or diseases (urinary tract infections, renal disorders, hypertension, diabetes) that are related to the study.
3)Those who are usually taking drugs and health foods affecting the study results (e.g. Chitosan, anserine, chrysanthemum polyphenols, lactic acid bacteria PA-3, supplement containing DNA / RNA, beer yeast, health food including vegetables (vegetable enzyme drink, green juice), etc.).
4) Whose diet is extremely irregular.
5) Those who are routinely drinking a large amount of alcohol.
6) Those who are habitually exercising such as marathon.
7) Currently, exercise therapy and diet therapy are performed/ planning to under the supervision of a physician .
8) 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]
9) Those who have participated in other clinical trials within before consent get one month, and those who are currently participating in other clinical trials.
10) At the physician's judgment, who are determined that there is a possibility that either increased risk to the subject, or sufficient data not obtained.
Target sample size
80
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
| 2019 | 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
87
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
| 2019 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 19 | Day |
Last modified on
| 2021 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040928
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
