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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020573
Receipt No. 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

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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
Email 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
Email kouzuki@med.tottori-u.ac.jp

Sponsor
Institute Department of Biological Regulation, School of Health Science, Faculty of Medicine, Tottori University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023753

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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