UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029694 |
|---|---|
| Receipt number | 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 08:27:02 |
* 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
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
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
zyasukawa@taiyokagaku.co.jp
Sponsor or person
Institute
Otsuma Women's University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033934
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
