UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045272 |
|---|---|
| Receipt number | R000051711 |
| Scientific Title | Examination of the relevance between vegetable intake and health management evaluation index |
| Date of disclosure of the study information | 2021/09/04 |
| Last modified on | 2022/04/25 18:56:27 |
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Basic information
Public title
Examination of the relevance between vegetable intake and health management evaluation index
Acronym
Examination of the relevance between vegetable intake and health management evaluation index
Scientific Title
Examination of the relevance between vegetable intake and health management evaluation index
Scientific Title:Acronym
Examination of the relevance between vegetable intake and health management evaluation index
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the relevance between vegetable intake and health management evaluation indicators.
Basic objectives2
Others
Basic objectives -Others
Verifying Relevance
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Estimated Vegetable Intake by Skin Carotenoid Concentration
Presenteeism
Absenteeism
Subjective sense of health
Health literacy
Stress level
Psychological safety
Well-being
Work Engagement
Health-Related Self-efficacy
Key secondary outcomes
Gender, age, height, weight, marital status, number of household members, smoking habits, drinking habits, medical history, sleep duration, sleep quality, exercise habits, 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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Men and women between 20 and 70 years old
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 are judged to be unsuitable as research subjects by their collaborators or research directors.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yukihiro |
| Middle name | |
| Last name | Nobuta |
Organization
KAGOME Co.,LTD.
Division name
Health&Business Department
Zip code
103-8461
Address
Nihonbashi-Hamacho FTower,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&Business Department
Zip code
103-8461
Address
Nihonbashi-Hamacho FTower,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
Nothing
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yamano Gakuen
Yamano College of Aesthetics
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Review Board of KAGOME Co.,LTD.
Address
Nihonbashi-Hamacho FTower,3-21-1,Nihonbashi-Hamacho,Chuo-ku,Tokyo
Tel
03-5623-8501
Takuji_Hayakawa@kagome.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2021-R07
Org. issuing International ID_1
Research Ethics Review Board of KAGOME Co.,LTD.
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | 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
| 2021 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Since there was relevance between vegetable intake and presenteeism in the previous report
Management information
Registered date
| 2021 | Year | 08 | Month | 26 | Day |
Last modified on
| 2022 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051711
