UMIN-CTR Clinical Trial

Basic information
Public title	Effects of tastant on salivation flow
Acronym	Effects of tastant on salivation flow
Scientific Title	Effects of tastant on salivation flow
Scientific Title:Acronym	Effects of tastant on salivation flow
Region	Japan

Condition
Condition	Xerostomia
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose is to measure changes in saliva flow during long-term taste stimulation by taste substances.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in saliva flow over time
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Factorial
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	6
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Sustained administration of sweet taste
Interventions/Control_2	Sustained administration of sweet taste
Interventions/Control_3	Sustained administration of sweet taste
Interventions/Control_4	Sustained administration of sweet taste
Interventions/Control_5	Sustained administration of umami taste
Interventions/Control_6	Sustained administration of umami taste
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy adults over 20 years old of Okayama University School of Dentistry and staff members of Okayama University Hospital
Key exclusion criteria	Persons with a history of chemotherapy and radiation therapy for endocrine, immunological disease, liver damage, kidney damage or head and neck cancer and cold and Zinc deficiency and Those receiving medication that may have a direct effect on thirst and Those who have saliva at rest for 10 minutes of 1 mL or less and Those who have saliva of 2g or less when stimulating the Saxon test.
Target sample size	22

Research contact person
Name of lead principal investigator	1st name HIKARU Middle name Last name SUGIMOTO
Organization	Okayama University Hospital
Division name	Occlusion and Removable Prosthodontics
Zip code	7008525
Address	2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Okayama
TEL	086-235-6687
Email	sugimoto.hika@s.okayama-u.ac.jp

Public contact
Name of contact person	1st name HIKARU Middle name Last name SUGIMOTO
Organization	Okayama University Hospital
Division name	Occlusion and Removable Prosthodontics
Zip code	7008525
Address	2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Okayama
TEL	086-235-6687
Homepage URL
Email	sugimoto.hika@s.okayama-u.ac.jp

Sponsor
Institute	Okayama University
Institute
Department

Funding Source
Organization	Okayama University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Okayama University Ethics Review Committee
Address	2-5-1 Shikata-cho, Kita-ku, Okayama-shi
Tel	086-235-6938
Email	mae6605@adm.okayama-u.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	2021 Year 08 Month 31 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	2021 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date	2021 Year 09 Month 01 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 06 Month 21 Day
Last modified on	2021 Year 06 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050952