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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044454
Receipt No. R000050750
Scientific Title Examination of the chewing number of foods
Date of disclosure of the study information 2021/06/07
Last modified on 2021/06/07

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Basic information
Public title Examination of the chewing number of foods
Acronym Examination of the chewing number of foods
Scientific Title Examination of the chewing number of foods
Scientific Title:Acronym Examination of the chewing number of foods
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Measurement of chewing number
Basic objectives2 Others
Basic objectives -Others Consideration of how much familiar foods are chewed
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Number of chews
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 over 20 years of age
(2) Subjects giving written informed consent
(3)Subjects who eat 10g of fish sausage with one mouth and chew 39-53 times before swallowing
Key exclusion criteria (1)Individuals who may develop allergies in connection with the test
(2) Individuals who have the will of pregnancy or are breast-feeding during the study period
(3)Individuals deemed inappropriate by the study director to participate in the study
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Kenji
Middle name
Last name Osawa
Organization Lotte Co., Ltd.
Division name Central Laboratory, Kamukoto Research Department
Zip code 336-8601
Address 1-1, Numakage-3chome, Minami-ku, Saitama
TEL 048-837-0744
Email oosawa_kenji@lotte.co.jp

Public contact
Name of contact person
1st name Misaki
Middle name
Last name Matsui
Organization Lotte Co., Ltd.
Division name Central Laboratory, Kamukoto Research Department
Zip code 336-8601
Address 1-1, Numakage-3chome, Minami-ku, Saitama
TEL 048-837-0744
Homepage URL
Email matsui_misaki@lotte.co.jp

Sponsor
Institute Lotte Co., Ltd.
Institute
Department

Funding Source
Organization Lotte 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 Shiba Palace Clinic
Address 6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel 03-5408-1590
Email jimukyoku@mail.souken-r.com

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 06 Month 07 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
2021 Year 05 Month 20 Day
Date of IRB
2021 Year 06 Month 03 Day
Anticipated trial start date
2021 Year 06 Month 14 Day
Last follow-up date
2021 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Elastic foods and hard foods are chewed more often.

Management information
Registered date
2021 Year 06 Month 07 Day
Last modified on
2021 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050750

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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