UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039695 |
|---|---|
| Receipt number | R000045277 |
| Scientific Title | The validity assessment of vegetable intake by handy diet record |
| Date of disclosure of the study information | 2020/03/04 |
| Last modified on | 2021/05/12 16:00:41 |
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Basic information
Public title
The validity assessment of vegetable intake by handy diet record
Acronym
The validity assessment of vegetable intake by handy diet record
Scientific Title
The validity assessment of vegetable intake by handy diet record
Scientific Title:Acronym
The validity assessment of vegetable intake by handy diet record
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to verify the validity of vegetable intake measured by hand
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation with vegetable intake by handy diet record and by photographic diet record
Key secondary outcomes
Sex, Age, Living state, marriage, Occupation, Height, Weight, Number of household members, Economic comfort, Frequency of cooking, TTM stage of vegetable intake
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Healthy adults whose age at the time of consent acquisition date is from 20 years old to under 69 years old
2) Subjects who obtained informed consents
Key exclusion criteria
1)Persons without informed consent
2)Persons who are difficult to measure by hand due to injury or illness
3)Persons who receive dietary advice from health care workers (doctor,nutrition,public health nurse) and keep a dietary record
(Excluding voluntary dietary record)
4)Persons who are judged to be unsuitable as research subjects by their collaborators or research directors
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yukihiro |
| Middle name | |
| Last name | Nobuta |
Organization
KAGOME CO.,LTD.
Division name
Health & Wellness Business Department
Zip code
103-8461
Address
Nihonbashi-Hamacho F Tower,3-21-1,Nihonbashi-Hamacho,Chuo-ku,Tokyo
TEL
03-5623-8501
Yukihiro_Nobuta@kagome.co.jp
Public contact
Name of contact person
| 1st name | Yukihiro |
| Middle name | |
| Last name | Nobuta |
Organization
KAGOME CO.,LTD.
Division name
Health & Wellness Business Department
Zip code
103-8461
Address
Nihonbashi-Hamacho F Tower,3-21-1,Nihonbashi-Hamacho,Chuo-ku,Tokyo
TEL
03-5623-8501
Homepage URL
Yukihiro_Nobuta@kagome.co.jp
Sponsor or person
Institute
KAGOME CO.,LTD.
Institute
Department
Personal name
Funding Source
Organization
KAGOME CO.,LTD.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kagawa Nutrition University
Name of secondary funder(s)
MyVoice Communications, Inc
IRB Contact (For public release)
Organization
KAGOME Co.,LTD.
Address
Nihonbashi-hamacho F-Tower, 3-21-1 Nihonbashi-hamacho, Chuo-ku, Tokyo 103-8461, Japan
Tel
03-5623-8501
Takuji_Hayakawa@kagome.co.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 | 03 | Month | 04 | 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
Completed
Date of protocol fixation
| 2020 | Year | 03 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 17 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We verify correlation with vegetable intake by handy diet record and by photographic diet record
Management information
Registered date
| 2020 | Year | 03 | Month | 04 | Day |
Last modified on
| 2021 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045277
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
