UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048363
Receipt number 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 2023/01/12 09:03:29

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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 or person

Institute

Department of Ophthalmology, Seirei Hamamatsu General Hospital

Institute

Department

Personal name



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

Enrolling by invitation

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

2023 Year 01 Month 12 Day



Link to view the page

Value
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