UMIN-CTR Clinical Trial

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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