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
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
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
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
