UMIN-CTR Clinical Trial

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
Email	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
Email	Yukihiro_Nobuta@kagome.co.jp

Sponsor
Institute	KAGOME Co.,LTD.
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051711