UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029616 |
|---|---|
| Receipt number | R000033832 |
| Scientific Title | Suppression effect on tooth staining evaluated in the newly developed tea beverage/ Randomized controlled trials with double blind crossover study |
| Date of disclosure of the study information | 2017/10/18 |
| Last modified on | 2018/07/10 19:24:03 |
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Basic information
Public title
Suppression effect on tooth staining evaluated in the newly developed tea beverage/ Randomized controlled trials with double blind crossover study
Acronym
Suppression effect on tooth staining evaluated in the newly developed tea beverage
Scientific Title
Suppression effect on tooth staining evaluated in the newly developed tea beverage/ Randomized controlled trials with double blind crossover study
Scientific Title:Acronym
Suppression effect on tooth staining evaluated in the newly developed tea beverage
Region
| Japan |
Condition
Condition
None (Healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate suppression effect on tooth staining after having tea for 3 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tooth staining
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
Drink the test tea once a day for 3 weeks followed by washout-period, after which drink the placebo tea once a day for 3 weeks.
Interventions/Control_2
Drink the placebo tea once a day for 3 weeks followed by washout-period, after which drink the test tea once a day for 3 weeks.
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
| 18 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Female
Key inclusion criteria
1)Japanese Females aged from 18 to 29, when giving the informed consent.
(2)Subjects who never smoke tobacco.
Key exclusion criteria
1. Subjects who are judged as unsuitable for lifestyle questionnaires.
2. Subjects who may have allergy to test foods.
3. Subjects with big covered product or fillings of the front teeth.
4. Subjects who have chronic diseases requiring regular administration, or who have severe diseases.
5. Subjects who have a medical history of serious disease e.g., diabetes, liver disease, kidney disease, and/or heart disease, thyroid gland disease, adrenal gland disease, and/or metabolic disorder.
6. Individuals who have a medical history of diseases affecting digestion and absorption.
7.Subjects who have participated other clinical studies within 1 month of giving the informed consent or who are planning to participate other clinical studies during this study.
8. Subjects who have a medical history of drug. dependence or alcohol dependence.
9. Subjects who are or willing to be pregnant, or who are breast-feeding during this study.
10. Subjects who are planning to have dental work done during this study.
11.Subjects who work in a company developing or manufacturing functional foods.
12. Subjects who are judged as unsuitable by doctor for other reasons.
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuko Momoi |
Organization
Tsurumi University
Division name
School of Dental Medicine Department of Operative Dentistry
Zip code
Address
2-1-3 Tsurumi Tsurumi-ku Yokohama Kanagawa, Japan
TEL
045-580-8426
momoi-y@tsurumi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaoru Ohmori |
Organization
Tsurumi University
Division name
School of Dental Medicine Department of Operative Dentistry
Zip code
Address
2-1-3 Tsurumi Tsurumi-ku Yokohama Kanagawa, Japan
TEL
045-580-8427
Homepage URL
omori-k@tsurumi-u.ac.jp
Sponsor or person
Institute
Tsurumi University
Institute
Department
Personal name
Funding Source
Organization
Kirin Company, Limited
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
Address
Tel
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
| 2017 | Year | 10 | Month | 18 | 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
| 2017 | Year | 09 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 24 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 24 | Day |
Date trial data considered complete
| 2018 | Year | 07 | Month | 02 | Day |
Date analysis concluded
| 2018 | Year | 07 | Month | 04 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 18 | Day |
Last modified on
| 2018 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033832
