UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030924 |
|---|---|
| Receipt number | 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 11:05:12 |
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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
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
k.s@cpcc.co.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
