UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046295
Receipt number R000052791
Scientific Title Verification of the correlation between food preferences and daily dietary content or lifestyle
Date of disclosure of the study information 2021/12/06
Last modified on 2022/06/17 08:22:33

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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 or person

Institute

KAGOME CO. LTD.

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052791


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name