UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Suppression effect on tooth staining evaluated in the newly developed tea beverage/ Randomized controlled trials with double blind crossover study
Title of the study (Brief title)	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	Yasuko Momoi
Organization	Tsurumi University
Division name	School of Dental Medicine Department of Operative Dentistry
Address	2-1-3 Tsurumi Tsurumi-ku Yokohama Kanagawa, Japan
TEL	045-580-8426
Email	momoi-y@tsurumi-u.ac.jp

Public contact
Name of contact person	Kaoru Ohmori
Organization	Tsurumi University
Division name	School of Dental Medicine Department of Operative Dentistry
Address	2-1-3 Tsurumi Tsurumi-ku Yokohama Kanagawa, Japan
TEL	045-580-8427
Homepage URL
Email	omori-k@tsurumi-u.ac.jp

Sponsor
Institute	Tsurumi University
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 09 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033832