UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048464 |
|---|---|
| Receipt number | R000055233 |
| Scientific Title | Evaluation of the health effects of chewing food |
| Date of disclosure of the study information | 2022/07/28 |
| Last modified on | 2023/02/07 07:55:47 |
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Basic information
Public title
Evaluation of the health effects of chewing food
Acronym
Evaluation of the health effects of chewing food
Scientific Title
Evaluation of the health effects of chewing food
Scientific Title:Acronym
Evaluation of the health effects of chewing food
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Verification of effects on gene expression
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Gene analysis using miRNA seq
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test food (continuous intake)
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
| 65 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy adults in their 65 to 74
(2) Individuals who are independent in activities of daily living such as excretion, bathing, walking, eating, and grooming
(3) Individuals who have 20 or more remaining teeth
(4) Individuals who can eat tasteless chewing gum
(5) Individuals who do not usually eat chewing gum
(6) Individuals who agree to fast 8 hours before the time of arrival
(7) Individuals who agree that the cooperation fee cannot be paid if the non-ingestion date is 9 days or more out of the 30-day intake period.
(8) Individuals who agree to discard the surplus test sample
(9) The analysis of this test is scheduled to be completed this year, but it may be re-analyzed several years later and published in a treatise. Individuals who agree with that point.
Key exclusion criteria
(1)Individuals with a history of systemic diseases such as cerebral infarction and orthopedic diseases
(2)Individuals with cognitive problems
(3)Individuals who are currently receiving dental treatment
(4)Individuals with diabetes, dyslipidemia (hyperlipidemia), liver disease
(5)Individuals taking medications
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Ando |
Organization
Lotte Co., Ltd.
Division name
Central Laboratory, Future Value R&D Department, Frontier R&D Section
Zip code
336-8601
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0187
andou_tomonori@lotte.co.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Sato |
Organization
Lotte Co., Ltd.
Division name
Central Laboratory, Future Value R&D Department, Frontier R&D Section
Zip code
336-8601
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0187
Homepage URL
Satou_Shouta@lotte.co.jp
Sponsor or person
Institute
Lotte Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Lotte Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
The University of Tokyo
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
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
| 2022 | Year | 07 | Month | 28 | 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
16
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 29 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 26 | Day |
Last modified on
| 2023 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055233
