UMIN-CTR Clinical Trial

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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048363
Receipt No. R000055123
Scientific Title Encouragement to increase vegetable intake using an equipment to measure skin carotenoid levels
Date of disclosure of the study information 2022/08/01
Last modified on 2022/07/13

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Basic information
Public title Encouragement to increase vegetable intake using an equipment to measure skin carotenoid levels
Acronym Increase in vegetable intake using the measurement of skin carotenoids levels
Scientific Title Encouragement to increase vegetable intake using an equipment to measure skin carotenoid levels
Scientific Title:Acronym Increase in vegetable intake using the measurement of skin carotenoids levels
Region
Japan

Condition
Condition healthy subjects
Classification by specialty
Medicine in general Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the improvement of vegetable intake by the dietary education using Veggie Meter that quantifies skin carotenoid levels.
Basic objectives2 Others
Basic objectives -Others To investigate the factors that associate with skin carotenoid levels in healthy children.
Trial characteristics_1 Others
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes skin carotenoid level
Key secondary outcomes

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 Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 dietary education
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

Not applicable
Gender Male and Female
Key inclusion criteria Subjects who agree to participate in this study and submit signed consent forms
Key exclusion criteria none
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Akira
Middle name
Last name Obana
Organization Seirei Hamamatsu General Hospital
Division name Department of Ophthalmology
Zip code 430-8558
Address Naka-ku
TEL 0534742222
Email obana@sis.seirei.or.jp

Public contact
Name of contact person
1st name Mitsuo
Middle name
Last name Kimata
Organization Seirei Hamamatsu General Hospital
Division name Clinical Research Center
Zip code 430-8558
Address 2-12-12 Sumiyoshi Naka-ku, Hamamatsu City, Shizuoka, Japan
TEL 0534742222
Homepage URL
Email m-kimata@sis.seirei.or.jp

Sponsor
Institute Department of Ophthalmology, Seirei Hamamatsu General Hospital
Institute
Department

Funding Source
Organization Health & Welfare department, Public Health Promotion Division, Hamamatsu City
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Tokoha University, Hamamatsu University School of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization Clinical Research Center, Seirei Hamamatsu General Hospital
Address 2-12-12 Sumiyoshi Naka-ku, Hamamatsu City, Shizuoka, Japan
Tel 0534742222
Email m-kimata@sis.seirei.or.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
2022 Year 08 Month 01 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 Preinitiation
Date of protocol fixation
2022 Year 05 Month 11 Day
Date of IRB
2022 Year 05 Month 18 Day
Anticipated trial start date
2022 Year 08 Month 01 Day
Last follow-up date
2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 07 Month 13 Day
Last modified on
2022 Year 07 Month 13 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055123

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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