![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
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 |
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 |
|
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 |
|
|
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 |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 |
|
||||||
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 | |
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 | |
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 |
|
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 |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry |
|
||||||
Date trial data considered complete |
|
||||||
Date analysis concluded |
|
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 |
|
||||||
Last modified on |
|
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 |