UMIN-CTR Clinical Trial

Basic information
Public title	The effect of grape-derived pomace on improving oral environment
Acronym	Grape pomace and oral environment
Scientific Title	The effect of grape-derived pomace extract supplementation on oral periodontal disease-related bacteria
Scientific Title:Acronym	Grape pomace extract trial on periodontal disease-related bacteria
Region	Japan

Condition
Condition	Nothing
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of grape-derived pomace extract supplementation on preventing the increase of periodontal disease-related bacteria.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The ocnsentration of P. gingivalis in saliva
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
Dynamic allocation
Institution consideration
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Participants consume 1 tablet including 27 mg oleanolic acid every day before night sleeping.
Interventions/Control_2	Participants consume 1 placebo tablet not including oleanolic acid every day before night sleeping.
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	(1) 20 years old or over, and less than 80 years. (2) 20 % or over in Bleeding of Probing(BOP) (4) Applicants who understand well the purpose and contents of this trial. Additionally, who can agree to participate by his/her will.
Key exclusion criteria	(1) Having allergy against grape or starch (2) Pregnant of breath feeding (3) Who need medical treatment for periodontal disease. (4) Participated in another clinical trial within 3 month. (5) Who used antibiotics within 2 weeks (6) Smoker (7) Others who are judged to be ineligible by the dentist.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Tetsu Middle name Last name Kinoshita
Organization	Institute of Community Life Sciences Co., Ltd.
Division name	Social Epidemiology Institute
Zip code	791-0243
Address	1383-2 Hiraimachi, Matsuyama-city, Ehime
TEL	089-904-7811
Email	tetsu.prospective@gmail.com

Public contact
Name of contact person	1st name Tetsu Middle name Last name Kinoshita
Organization	Institute of Community Life Sciences Co., Ltd.
Division name	Social Epidemiology Institute
Zip code	791-0243
Address	1383-2 Hiraimachi, Matsuyama-city, Ehime
TEL	089-904-7811
Homepage URL
Email	tetsu.prospective@gmail.com

Sponsor
Institute	Institute of Community Life Sciences Co., Ltd.
Institute
Department

Funding Source
Organization	NIPPON FLOUR MILLS 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	Ehime University Hospital Institutional Review Board
Address	Shitsukawa, Toon, Ehime
Tel	089-960-5172
Email	rinri@m.ehime-u.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 10 Month 05 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	Completed
Date of protocol fixation	2020 Year 09 Month 28 Day
Date of IRB	2020 Year 09 Month 28 Day
Anticipated trial start date	2020 Year 09 Month 29 Day
Last follow-up date	2020 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2020 Year 09 Month 03 Day
Last modified on	2021 Year 02 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047526