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

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 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

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

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


Research Plan
Registered date File name
2021/12/02 研究計画書.doc

Research case data specifications
Registered date File name
2021/12/02 倫理申請書書.doc

Research case data
Registered date File name