UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory study on the change of oral hygiene condition by the food containing aroma component in elderly who requires nursing care
Acronym	Study on the change of oral hygiene condition by the food containing aroma component
Scientific Title	Exploratory study on the change of oral hygiene condition by the food containing aroma component in elderly who requires nursing care
Scientific Title:Acronym	Study on the change of oral hygiene condition by the food containing aroma component
Region	Japan

Condition
Condition	Elderly who requires nursing care
Classification by specialty	Geriatrics Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate the effect of the food containing aroma component intake on oral hygiene condition in elderly who requires nursing care.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Total number of oral bacteria
Key secondary outcomes	1) Number of oral opportunistic pathogen 2) Oral condition 3) Activities of daily living 4) Disease morbidity (fever, pneumonia, etc.) 5) Periodontal bacteria 6) Periodontal pocket 7) Others (dietary intake, water intake, arterial oxygen saturation and body weight)

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Subjects will receive oral administration of 5 g gel including aroma component twice daily (10 g/day).
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	117 years-old >=
Gender	Male and Female
Key inclusion criteria	Oral hygiene condition: total number of oral bacteria > mean of healthy adults
Key exclusion criteria	1) Severe disease 2) Swallowing is extremely difficult 3) Diagnosis of inappropriate by physician
Target sample size	50

Research contact person
Last 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
1st 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	1) School of Pharmaceutical Sciences, University of Shizuoka 2) Welgarden Ikoen
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Research Ethics Committee, Gifu Pharmaceutical University
Address	1-25-4 Daigakunishi, Gifu, JAPAN
Tel	058-230-8100
Email	tanakam@gifu-pu.ac.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	社会福祉法人ウエルガーデン・ウエルガーデン伊興園（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 08 Month 24 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	50
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	2018 Year 08 Month 01 Day
Date of IRB	2018 Year 08 Month 01 Day
Anticipated trial start date	2018 Year 08 Month 24 Day
Last follow-up date	2019 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	2018 Year 08 Month 24 Day
Last modified on	2019 Year 04 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038647