UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039215 |
|---|---|
| Receipt number | R000044725 |
| Scientific Title | Fecal and body fat percentage improvement effect confirmation test by functional nozawana processed food in Japan |
| Date of disclosure of the study information | 2020/01/22 |
| Last modified on | 2020/01/21 16:25:13 |
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Basic information
Public title
Randomized control trial for functional nozawana processed food to improve defecation and body fat percentage
Acronym
J-Knock study
Scientific Title
Fecal and body fat percentage improvement effect confirmation test by functional nozawana processed food in Japan
Scientific Title:Acronym
J-Knock study
Region
| Japan |
Condition
Condition
A healthy male and female between 20 and 64 years old with a BMI of 25 or more and less than 30
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of functional nozawana processed food on body fat percentage improvement
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Change in body fat percentage after intervention
Key secondary outcomes
Change in serum lipid level, body weight, BMI,
Intestinal flora, stool frequency / week and shape
Base
Study type
Interventional
Study design
Basic design
Factorial
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
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Administration of functional nozawana processed food withhigh-glucosinolates + Lactic acid bacteria of 5 g/day for three months
Interventions/Control_2
Administration of functional nozawana processed food withhigh-glucosinolates + without Lactic acid bacteria of 5 g/day for three months
Interventions/Control_3
Administration of functional nozawana processed food withlow-glucosinolates + Lactic acid bacteria of 5 g/day for three months
Interventions/Control_4
Administration of functional nozawana processed food withlow-glucosinolates + without Lactic acid bacteria of 5 g/day for three months
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Candidate patients have to meet all the following inclusion criteria to participate in
the study.
(1) Male and female aged 20 to 65 years old at the time of acquisition
(2) Persons whose BMI is 25 or more and less than 30
(3) A person who received a sufficient explanation about the examination, can understand the contents, obtains document consent by the principal
Key exclusion criteria
(1) Persons who regularly eat medicines, functional display foods, foods for specified health use, health foods, etc., which are likely to affect the test results
(2) Those currently on a diet or planning to diet
(3) Those who eat more than 200 g of Nozawana pickles a day
(4) Heavy alcohol drinkers
(5) Persons with extremely irregular eating habits, those with irregular life rhythms
(6) Persons who have a severe current medical history in the heart, liver, kidney and digestive organs
(7) Those pregnant or planning pregnancy, and those who are breastfeeding
(8) Persons who are allergic to pharmaceuticals and foods (in particular Nozawana product)
(9) Those who donated blood donated from the previous month or started donating 200 mL of whole blood
(10) A man who donated 400 mL of whole blood three months before the start of the test
(11) Women who donated 400 mL of whole blood from 4 months before the start of the test
(12) A man who may donate more than 1,200 mL of whole blood from 12 months plus total blood draw amount of this test.
(13) Women who may donate more than 800 mL of whole blood from 12 months plus total blood draw amount of this test.
(14) Person who judged that participation in the examination is inappropriate by the investigator (medical doctor) or exam sharing physician
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Michihiro |
| Middle name | |
| Last name | Mutoh |
Organization
Research Center for Cancer Prevention and Screening, National Cancer Center
Division name
Division of Prevention
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3547-5201
mimutoh@ncc.go.jp
Public contact
Name of contact person
| 1st name | Michihiro |
| Middle name | |
| Last name | Mutoh |
Organization
Research Center for Cancer Prevention and Screening, National Cancer Center
Division name
Division of Prevention
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3547-5201
Homepage URL
mimutoh@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Agriculture, Fishery and Forestry, Japan
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
National Cancer Center Research Ethics Review Committee
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
Tel
03-3542-2511
irst@ml.res.ncc.go.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
| 2020 | Year | 01 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2021 | 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
| 2020 | Year | 01 | Month | 21 | Day |
Last modified on
| 2020 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044725
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/12/29 | 野沢菜試験横並びデータ(割付結果あり)_20201228.xlsx |
