UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020573 |
|---|---|
| Receipt number | R000023753 |
| Scientific Title | Effect of monosodium glutamate on cognitive function in people with dementia |
| Date of disclosure of the study information | 2016/01/15 |
| Last modified on | 2016/01/19 17:06:14 |
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Basic information
Public title
Effect of monosodium glutamate on cognitive function in people with dementia
Acronym
Effect of monosodium glutamate on cognitive function in people with dementia
Scientific Title
Effect of monosodium glutamate on cognitive function in people with dementia
Scientific Title:Acronym
Effect of monosodium glutamate on cognitive function in people with dementia
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate that monosodium glutamate affect on cognitive function in people with dementia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The result of Touch panel-type Dementia Assessment Scale (TDAS) just after intervention.
Key secondary outcomes
The results of Gottfries, Brane and Steen scale (GBSS), questionnaire and blood tests just after intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Subjects take a meal with 0.9g monosodium glutamate three times a day (breakfast, lunch and dinner) for three months. We perform tests three times (before intervention, after intervention and one month after the intervention period).
Interventions/Control_2
Subjects take a meal with 0.28g NaCl three times a day (breakfast, lunch and dinner) for three months. We perform tests three times (before intervention, after intervention and one month after the intervention period).
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Subjects with dementia
2) Subjects that informed consent was provided from the person and the relative
Key exclusion criteria
1) Subjects who are diagnosed taste disturbance
2) Subjects who received chemotherapy within the past one year
3) Subjects who have been performed the dietary therapy for hypertension such as sodium restriction
4) Subjects who are assessed by the principal investigator due to other reasons
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuya Urakami |
Organization
School of Health Science, Faculty of Medicine, Tottori University
Division name
Department of Biological Regulation
Zip code
Address
86 Nishicho, Yonago, Tottori, Japan
TEL
0859-38-6354
kurakami@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Minoru Kouzuki |
Organization
School of Health Science, Faculty of Medicine, Tottori University
Division name
Department of Biological Regulation
Zip code
Address
86 Nishicho, Yonago, Tottori, Japan
TEL
0859-38-6358
Homepage URL
kouzuki@med.tottori-u.ac.jp
Sponsor or person
Institute
Department of Biological Regulation, School of Health Science, Faculty of Medicine, Tottori University
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Co., Inc.
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
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
| 2016 | Year | 01 | Month | 15 | 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
| 2014 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | 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
| 2016 | Year | 01 | Month | 14 | Day |
Last modified on
| 2016 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023753
