UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041675
Receipt No. R000047526
Scientific Title The effect of grape-derived pomace extract supplementation on oral periodontal disease-related bacteria
Date of disclosure of the study information 2020/10/05
Last modified on 2020/09/03

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 Preinitiation
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

Other
Other related information

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


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.