UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031279 |
|---|---|
| Receipt number | R000035710 |
| Scientific Title | Examination of salivary secretory reflex by sodium glutamate in minor salivary glands of healthy adults |
| Date of disclosure of the study information | 2018/02/14 |
| Last modified on | 2018/02/13 17:27:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Examination of salivary secretory reflex by sodium glutamate in minor salivary glands of healthy adults
Acronym
Examination of salivary secretory reflex by sodium glutamate in minor salivary glands of healthy adults
Scientific Title
Examination of salivary secretory reflex by sodium glutamate in minor salivary glands of healthy adults
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Shizuko, Satoh-Kuriwada |
Organization
Tohoku University
Division name
Division of Oral Diagnosis
Zip code
Address
4-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL
022-717-8390
kuri-shu@dent.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shizuko, Satoh-Kuriwada |
Organization
Tohoku University
Division name
Division of Oral Diagnosis
Zip code
Address
4-1, seiryo-machi, aoba-ku, sendai, japan
TEL
022-717-8390
Homepage URL
kuri-shu@dent.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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)
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
| 2018 | Year | 02 | Month | 14 | 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
| 2018 | Year | 02 | Month | 13 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035710
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
