UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000029694
Receipt No. R000033934
Scientific Title Effects of continuous ingestion of food containing plant extract on plaque adhesion
Date of disclosure of the study information 2019/01/01
Last modified on 2020/06/14 (Ver. 5)

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Basic information
Public title Effects of continuous ingestion of food containing plant extract on plaque adhesion
Acronym Effects of continuous ingestion of food containing plant extract on plaque adhesion
Scientific Title Effects of continuous ingestion of food containing plant extract on plaque adhesion
Scientific Title:Acronym Effects of continuous ingestion of food containing plant extract on plaque adhesion
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation of plaque adhesion effects of food containing plant extract
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Plaque adhesion (first observation, second observation)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Oral intake of the food containing plant extract (continuous)
Interventions/Control_2 Oral intake of placebo food (continuous)
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
65 years-old >
Gender Female
Key inclusion criteria Healthy females who are age from 20 to 64.
Key exclusion criteria 1) Patients who have serious disease or subjects who have serious disease history.
2) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination.
3) Subjects who are judged unfit to enroll in this trial by the investigator.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Mikiko
Middle name
Last name Kawaguchi
Organization Otsuma Women's University
Division name Department of Food Science Faculty of Home Economics
Zip code 102-8357
Address 12 Sanbancho, Chyyoda-ku, Tokyo, 102-8357 JAPAN
TEL 03-5275-6117
Email mikiko-kawa@otsuma.ac.jp

Public contact
Name of contact person
1st name Zenta
Middle name
Last name Yasukawa
Organization Taiyo Kagaku Co., Ltd.
Division name Nutrition division
Zip code 510-0844
Address 1-3, Takara-cho, Yokkaichi-shi, Mie, 510-0844, JAPAN
TEL 059-347-5411
Homepage URL
Email zyasukawa@taiyokagaku.co.jp

Sponsor
Institute Otsuma Women's University
Institute
Department

Funding Source
Organization Taiyo Kagaku Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Nihon University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Otsuma Women's University
Address 12 Sanbancho, Chyyoda-ku, Tokyo, 102-8357 JAPAN
Tel 03-5275-6117
Email mikiko-kawa@otsuma.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
2019 Year 01 Month 01 Day

Related information
URL releasing protocol None
Publication of results Published

Result
URL related to results and publications None
Number of participants that the trial has enrolled 20
Results 
EGCg-containing foods have an inhibitory effect on dental plaque formation and adhesion
Results date posted
2020 Year 01 Month 09 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Healthy female university students aged between 20 and 23 years
Participant flow 
Recruited as paid volunteers, and explanatory documents and a consent form were handed over to them. Full explanations were provided, and after informed consent based on the participants' free will was obtained in written form.
Adverse events 
There was no report of any adverse event.
Outcome measures 
plaque adhesion (plaque index)
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 07 Month 24 Day
Date of IRB
2017 Year 10 Month 25 Day
Anticipated trial start date
2017 Year 10 Month 25 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Jpn Pharmacol Ther, 47(3), 409-414, 2019

Management information
Registered date
2017 Year 10 Month 24 Day
Last modified on
2020 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033934