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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030924
Receipt No. R000035315
Scientific Title Body weight control effect of Nozawana pickled product (a pilot study)
Date of disclosure of the study information 2018/01/23
Last modified on 2018/07/24

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Basic information
Public title Body weight control effect of Nozawana pickled product (a pilot study)
Acronym Body weight control effect of Nozawana pickled product (a pilot study)
Scientific Title Body weight control effect of Nozawana pickled product (a pilot study)
Scientific Title:Acronym Body weight control effect of Nozawana pickled product (a pilot study)
Region
Japan

Condition
Condition A healthy male and female between 20 and 65 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 Dosage setting of Nozawana pickled product for randomized controlled trial
Basic objectives2 Others
Basic objectives -Others Functional evaluation of Nozawana pickled product for randomized controlled trial
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Percentage of people who were able to eat 200 g of Nozawana pickled product (Nozawana Zuke) for 5 days / week or more
Key secondary outcomes Change in body weight, body mass index, body fat percentage and intestinal flora

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Administration of Nozawana pickled product of 200 g/day for a month
Interventions/Control_2
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 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) Persons who are planning to travel on business with traveling during the examination period
(4) Heavy alcohol drinkers
(5) Persons with extremely irregular eating habits, those with irregular life rhythms
(6) Persons who have a history of severe disease history and current medical history in the heart, liver, kidney and digestive organs
(7) Persons with salinity limit
(8) Those pregnant or planning pregnancy, and those who are breastfeeding
(9) Participating in clinical trials of other medicinal products or health foods, within 4 weeks after completion of the study, or who plan to participate in other clinical trials after participating in the study
(10) Persons conducting ongoing treatment with drugs
(11) Persons who are allergic to pharmaceuticals and foods (in particular Nozawana pickled product)
(12) Those who donated blood donated from the previous month or started donating 200 mL of whole blood
(13) A man who donated 400 mL of whole blood three months before the start of the test
(14) Women who donated 400 mL of whole blood from 4 months before the start of the test
(15) A man who may donate more than 1,200 mL of whole blood from 12 months plus total blood draw amount of this test.
(16) Women who may donate more than 800 mL of whole blood from 12 months plus total blood draw amount of this test.
(17) Person who judged that participation in the examination is inappropriate by the investigator (medical doctor) or exam sharing physician
Target sample size 22

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michihiro Mutoh
Organization National Cancer Center
Division name Epidemiology and Prevention Division
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL 03-3542-2511
Email mimutoh@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsuhisa Sakano
Organization CPCC Co., Ltd
Division name Clinical Research Planning Department
Zip code
Address 4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo, Japan
TEL 03-5297-3112
Homepage URL
Email k.s@cpcc.co.jp

Sponsor
Institute National Cancer Center
Institute
Department

Funding Source
Organization the Ministry of Agriculture, Forestry and Fisheries
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
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 KGC17C1
Org. issuing International ID_1 CPCC Co., Ltd.
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions チヨダパラメディカルケアクリニック

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 23 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
When counting the days of eating even one pack a day, the ingestion rate was 99.5%.
HDL cholesterol, body fat percentage, and BMI decreased, but no significant difference was observed.
The tested Nozawa vegetables ingestion increased the frequency of defecation.
The taste of tested Nozawa vegetables was slightly more delicious ( 2.8 points ) than normal (3 points).
The amount of the tested Nozawa vegetables who can eat 3 months was calculated as 2.2 packs.
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
2018 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 24 Day
Last follow-up date
2018 Year 03 Month 14 Day
Date of closure to data entry
2018 Year 05 Month 25 Day
Date trial data considered complete
2018 Year 05 Month 29 Day
Date analysis concluded
2018 Year 06 Month 04 Day

Other
Other related information We analyzed the questionnaire, physical measurement (body weight, BMI, body fat percentage), physiological examination, blood biochemical examination, hematological examination, intestinal bacterial examination and questionnaire (ingenuity and idea for consecutive eating). We are now planning to design randomized controlled trial using Nozawa vegetables (the amount, the period, and the number of people by statistical power calculation).

Management information
Registered date
2018 Year 01 Month 22 Day
Last modified on
2018 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035315

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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