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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035048
Receipt No. R000039957
Scientific Title Effect of food material on oral bacteria
Date of disclosure of the study information 2020/12/31
Last modified on 2020/03/03

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Basic information
Public title Effect of food material on oral bacteria
Acronym Effect of food material on oral bacteria
Scientific Title Effect of food material on oral bacteria
Scientific Title:Acronym Effect of food material on oral bacteria
Region
Japan

Condition
Condition aspirate pneumonia
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 A purpose of this study is to evaluate effect of food containing glycine as base material
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes quality of sleep (1-week after administration)
number of oral bacteria (1-week after administration)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 group of glycine-including food, for 1 week, at bedtime
Interventions/Control_2 group of non-glycine-including food, for 1 week, at bedtime
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 older adult without cognitive problems
Key exclusion criteria person who stop taking examination food for the duration of examination
sickness person
person who drink alcohol before sleeping
Target sample size 240

Research contact person
Name of lead principal investigator
1st name Sumio
Middle name
Last name Akifusa
Organization Kyushu Dental University
Division name School of Oral Health Sciences
Zip code 803-8580
Address 2-6-1, Manazuru, Kokurakita-ku, Kitakyushu
TEL 093-285-3107
Email r11akifusa@fa.kyu-dent.ac.jp

Public contact
Name of contact person
1st name Sumio
Middle name
Last name Akifusa
Organization Kyushu Dental University
Division name School of Oral Health Sciences
Zip code 803-8580
Address 2-6-1, Manazuru, Kokurakita-ku, Kitakyushu
TEL 093-285-3107
Homepage URL
Email r11akifusa@fa.kyu-dent.ac.jp

Sponsor
Institute Kyushu Dental Univsersity
Institute
Department

Funding Source
Organization FINE JAPAN 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 Ethics review board of Kyushu Dental University
Address 2-6-1, Manazuru, Kokurakita-ku, Kitakyushu, Japan
Tel 093-285-3107
Email gakusei@kyu-dent.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

Other administrative information
Date of disclosure of the study information
2020 Year 12 Month 31 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 No longer recruiting
Date of protocol fixation
2019 Year 04 Month 01 Day
Date of IRB
2019 Year 03 Month 22 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2020 Year 09 Month 08 Day
Date of closure to data entry
2020 Year 10 Month 31 Day
Date trial data considered complete
2020 Year 11 Month 30 Day
Date analysis concluded
2020 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 11 Month 28 Day
Last modified on
2020 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039957

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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