UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of salivary secretory reflex by sodium glutamate in minor salivary glands of healthy adults
Title of the study (Brief title)	Examination of salivary secretory reflex by sodium glutamate in minor salivary glands of healthy adults
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Dental medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Study of glutamate Na on minor salivary gland secretion
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	Minor Salivation secretion
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Single blind -participants are blinded
Control	Dose comparison
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	5
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Control(0mM Mono-Sodium-Glutamate)
Interventions/Control_2	5mM Mono-Sodium-Glutamate
Interventions/Control_3	10mM Mono-Sodium-Glutamate
Interventions/Control_4	50mM Mono-Sodium-Glutamate
Interventions/Control_5	100mM Mono-Sodium-Glutamate
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy men and women who agreed to participate in this research with written informed consent.
Key exclusion criteria	(1) Persons with eating disorders (2) Persons with taste disorders (3) Persons who have hypersensitive response to sodium glutamate (4) Those who can not self-judge due to dementia or the like (5) Those who wish to become pregnant during pregnancy, breast-feeding, or research period (6) Participating in other exams (7) Others who judged that a dentist is inappropriate for participating in the examin
Target sample size	30

Research contact person
Name of lead principal investigator	Shizuko, Satoh-Kuriwada
Organization	Tohoku University
Division name	Division of Oral Diagnosis
Address	4-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL	022-717-8390
Email	kuri-shu@dent.tohoku.ac.jp

Public contact
Name of contact person	Shizuko, Satoh-Kuriwada
Organization	Tohoku University
Division name	Division of Oral Diagnosis
Address	4-1, seiryo-machi, aoba-ku, sendai, japan
TEL	022-717-8390
Homepage URL
Email	kuri-shu@dent.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Non profit foundation
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	2018 Year 02 Month 14 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 02 Month 13 Day
Anticipated trial start date	2018 Year 02 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 02 Month 13 Day
Last modified on	2018 Year 02 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035710