UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory study about changes of oral hygiene condition by eating the food containing aroma component in dementia patients
Acronym	Exploratory study about changes of oral hygiene condition by eating the food containing aroma component in dementia patients
Scientific Title	Exploratory study about changes of oral hygiene condition by eating the food containing aroma component in dementia patients
Scientific Title:Acronym	Exploratory study about changes of oral hygiene condition by eating the food containing aroma component in dementia patients
Region	Japan

Condition
Condition	Dementia patients
Classification by specialty	Geriatrics Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of the food containing aroma component intake on oral hygiene condition in dementia patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Total number of oral bacteria
Key secondary outcomes	(1) Number of oral opportunistic pathogen (2) Number of oral periodontal bacteria (3) Oral hygiene conditions (tongue coating, bad breath, etc.) (4) Prevalence (fever, pneumonia, etc.) (5) Doctor's opinion

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	The food containing aroma component
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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) 65 years of age or older (2) Male and Female (3) Dementia (4) Diagnosed by a physician or a speech therapist as being capable of feeding training with food (in the case of tube feeding)
Key exclusion criteria	(1) Severe disease (2) Difficulty with Swallowing (3) Not permitted to join the study by doctors
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Michiko Middle name Last name Obara
Organization	Gifu Pharmaceutical University
Division name	Community Healthcare Pharmacy
Zip code	501-1196
Address	1-25-4 Daigakunishi, Gifu, Japan
TEL	058-230-8100
Email	obara@gifu-pu.ac.jp

Public contact
Name of contact person	1st name Michiko Middle name Last name Obara
Organization	Gifu Pharmaceutical University
Division name	Community Healthcare Pharmacy
Zip code	501-1196
Address	1-25-4 Daigakunishi, Gifu, Japan
TEL	058-230-8100
Homepage URL
Email	obara@gifu-pu.ac.jp

Sponsor
Institute	Community Healthcare Pharmacy, Gifu Pharmaceutical University
Institute
Department

Funding Source
Organization	UHA Mikakuto Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Medical Corporation Toujinkai Fujitate Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Japan Association of Health care Initiative
Address	1-15-10, Toranomon, Minato-ku, Tokyo
Tel	03-5157-3341
Email	info@jahi.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	医療法人藤仁会 藤立病院（大阪府）

Other administrative information
Date of disclosure of the study information	2021 Year 04 Month 21 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	2020 Year 11 Month 11 Day
Date of IRB	2020 Year 11 Month 13 Day
Anticipated trial start date	2021 Year 04 Month 21 Day
Last follow-up date	2021 Year 12 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	2021 Year 04 Month 20 Day
Last modified on	2021 Year 04 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050233