UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy test of oral stimuli on salivary secretion and components
Acronym	The efficacy test of oral stimuli on salivary secretion and components
Scientific Title	The efficacy test of oral stimuli on salivary secretion and components
Scientific Title:Acronym	The efficacy test of oral stimuli on salivary secretion and components
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of oral stimuli on salivary secretion.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Salivary secretion and components volume
Key secondary outcomes	Salivary secretion and components rate

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Single ingestion of the product. More than 24 hours washout between the ingestions. Ingestion order: product 1, product 2, product3, product4, product5.
Interventions/Control_2	Single ingestion of the product. More than 24 hours washout between the ingestions. Ingestion order: product 2, product 3, product1, product5, product4.
Interventions/Control_3	Single ingestion of the product. More than 24 hours washout between the ingestions. Ingestion order: product 3, product 1, product2, product4, product5.
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	50 years-old >
Gender	Male
Key inclusion criteria	Healthy subjects giving written informed consent.
Key exclusion criteria	1) Subjects with a history of allergy or might be liable to allergy related to the study 2) Subjects who have serious historical disease, marked impairment, or treatment in the liver, kidney, heart, lung, gastrointestinal tract, blood, endocrine system, or metabolism system 3) Subjects with low salivary secretion. 4) Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Shinji Middle name Last name Yamamoto
Organization	Kao Corporation
Division name	Personal Health Care Products Research
Zip code	131-8501
Address	2-1-3, Bunka Sumida-ku Tokyo, 131-8501, JAPAN
TEL	03-5630-9416
Email	yamamoto.shinji@kao.com

Public contact
Name of contact person	1st name Kenkichi Middle name Last name Yamamoto
Organization	Kao Corporation
Division name	Personal Health Care Products Research
Zip code	131-8501
Address	2-1-3, Bunka Sumida-ku Tokyo, 131-8501, JAPAN
TEL	03-5630-9416
Homepage URL
Email	yamamoto.kenkichi@kao.com

Sponsor
Institute	Kao Corporation
Institute
Department

Funding Source
Organization	Kao Corporation
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	Human Research Ethics Committee, Kao Corporation
Address	2-1-3, Bunka Sumida-ku Tokyo, 131-8501, JAPAN
Tel	03-5630-9786
Email	uesaka.toshio@kao.com

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	花王株式会社（東京都）

Other administrative information
Date of disclosure of the study information	2019 Year 04 Month 19 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	Completed
Date of protocol fixation	2019 Year 01 Month 22 Day
Date of IRB	2019 Year 01 Month 22 Day
Anticipated trial start date	2019 Year 04 Month 22 Day
Last follow-up date	2019 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 04 Month 15 Day
Last modified on	2020 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041599