UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035048 |
|---|---|
| Receipt number | R000039957 |
| Scientific Title | Effect of food material on oral bacteria |
| Date of disclosure of the study information | 2020/12/31 |
| Last modified on | 2022/06/01 11:22:16 |
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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
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
r11akifusa@fa.kyu-dent.ac.jp
Sponsor or person
Institute
Kyushu Dental Univsersity
Institute
Department
Personal name
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
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
https://prtimes.jp/main/html/rd/p/000000017.000009541.html
Publication of results
Unpublished
Result
URL related to results and publications
https://prtimes.jp/main/html/rd/p/000000017.000009541.html
Number of participants that the trial has enrolled
49
Results
There was no significant difference in total bacterial count and ADCHECK score before and after the intervention. TCI (tongue coating index) was significantly reduced in intervention group after intervention.
In the parsons with score 3 of ADCHECK at baseline, ADCHECK score was significantly lowered in the intervention group, but not in the control group. In contrast, total bacterial count did not change in both groups.
Results date posted
| 2021 | Year | 12 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
residents of nursing homes
Participant flow
there was no withdraw
Adverse events
not observed
Outcome measures
AADCHECK
TCI
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2022 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039957
