UMIN-CTR Clinical Trial

Basic information
Public title	Verification of the correlation between food preferences and health status or daily dietary content
Acronym	The effect of the food preferences on health status and daily dietary content
Scientific Title	Verification of the correlation between food preferences and health status or daily dietary content
Scientific Title:Acronym	The effect of the food preferences on health status and daily dietary content
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the correlation between food preferences and health status or daily diet.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation between food preferences and health screening data or daily diet record
Key secondary outcomes

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	65 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 65 years old 2) Subjects who obtained informed consents
Key exclusion criteria	1) Subjects who have food allergy to the test meals 2) Subjects who have restrictions on their daily diet according to the instructions of their family doctor or other health care provider 3) Subjects who get pregnant or breast-feed during the study period 4) Subjects who join other human studies 5) Subjects who are judged unsuitable for this study by investigators
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Shigenori Middle name Last name Suzuki
Organization	KAGOME CO., LTD.
Division name	Nature & Wellness Research Department
Zip code	329-2762
Address	17 Nishitomiyama, Nasushiobara city, Tochigi, Japan
TEL	+81-287-36-2935
Email	Shigenori_Suzuki@kagome.co.jp

Public contact
Name of contact person	1st name Shigenori Middle name Last name Suzuki
Organization	KAGOME CO., LTD.
Division name	Nature & Wellness Research Department
Zip code	329-2762
Address	17 Nishitomiyama, Nasushiobara city, Tochigi, Japan
TEL	+81-287-36-2935
Homepage URL
Email	Shigenori_Suzuki@kagome.co.jp

Sponsor
Institute	KAGOME CO., LTD.
Institute
Department

Funding Source
Organization	KAGOME CO., LTD.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kagome Ethics Committee
Address	Nihonbashi-hamacho F-Tower, 3-21-1 Nihonbashi-hamacho, Chuo-ku, Tokyo
Tel	+81-3-5623-8501
Email	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 10 Month 05 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	2020 Year 09 Month 17 Day
Date of IRB	2020 Year 09 Month 30 Day
Anticipated trial start date	2020 Year 10 Month 06 Day
Last follow-up date	2020 Year 11 Month 30 Day
Date of closure to data entry	2020 Year 12 Month 15 Day
Date trial data considered complete	2020 Year 12 Month 31 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information	Observation study (Cross-sectional study) Subjects are recruited from employees of KAGOME CO., LTD. in 2020 Oct..

Management information
Registered date	2020 Year 10 Month 02 Day
Last modified on	2020 Year 10 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047912

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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