UMIN-CTR Clinical Trial

Basic information
Public title	Verification of the correlation between food preferences and daily dietary content or lifestyle
Acronym	The effect of the food preferences on daily dietary content
Scientific Title	Verification of the correlation between food preferences and daily dietary content or lifestyle
Scientific Title:Acronym	Verification of the correlation between food preferences and daily dietary content or lifestyle
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 daily diet or lifestyle.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation between food preferences and 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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Healthy adults whose age at the time of consent acquisition date is 20 years old and over 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	800

Research contact person
Name of lead principal investigator	1st name Shigenori Middle name Last name SUZUKI
Organization	KAGOME CO. LTD.
Division name	Nature and Wellness Research Department
Zip code	329-2762
Address	17 Nishitomiyama, Nasushiobara city, Tochigi,JAPAN
TEL	0287-36-2935
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 and Wellness Research Department
Zip code	329-2762
Address	17 Nishitomiyama, Nasushiobara city, Tochigi,JAPAN
TEL	0287-36-2935
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	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	The ethics committees of KAGOME CO., LTD.
Address	3-21-1, F tower, Hamacho, Nihonbashi, Tyuo-ku, Tokyo, Japan
Tel	03-5623-8501
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	2021 Year 12 Month 06 Day

Related information
URL releasing protocol	No plans to release
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	1500
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 12 Month 02 Day
Date of IRB	2021 Year 12 Month 03 Day
Anticipated trial start date	2021 Year 12 Month 06 Day
Last follow-up date	2022 Year 01 Month 31 Day
Date of closure to data entry	2022 Year 02 Month 28 Day
Date trial data considered complete	2022 Year 03 Month 31 Day
Date analysis concluded	2022 Year 04 Month 30 Day

Other
Other related information	The study design is a cohort study, and we will recruit healthy subjects who reside in Tokyo, Kanagawa, Saitama and Chiba prefectures as of December 2021. Salt and other intake and taste preference will be investigated by dietary survey.

Management information
Registered date	2021 Year 12 Month 06 Day
Last modified on	2022 Year 06 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052791