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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039215
Receipt No. 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

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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
Email 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
Email mimutoh@ncc.go.jp

Sponsor
Institute National Cancer Center
Institute
Department

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
Email 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
URL(English) https://upload.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


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