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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014651
Receipt No. R000017045
Scientific Title The effect of ketogenic diet on dementia.
Date of disclosure of the study information 2014/08/01
Last modified on 2019/02/06

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Basic information
Public title The effect of ketogenic diet on dementia.
Acronym The effect of ketogenic diet on dementia.
Scientific Title The effect of ketogenic diet on dementia.
Scientific Title:Acronym The effect of ketogenic diet on dementia.
Region
Japan

Condition
Condition Alzheimer's dementia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 We evaluate the effect of ketogenic diet on the cognition in the healthy adults and Alzheimer's disease.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II,III

Assessment
Primary outcomes The improvement of cognition
Key secondary outcomes The change of molecules for appetite.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Subjects consume a drink containing
emulsified MCTs (20g) or placebo.
Interventions/Control_2 Subjects consume emulsified MCTs (20g) twice a day for 2 montths
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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Subjects fulfill the NINCDS-ADRDA for alzheimer's disease, and age- and sex-matched healthy volunteers.
Key exclusion criteria Participants were excluded if they had a prior medical history
Target sample size 60

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Hirosi Kunugi
Organization National Center of Neurology and Psychiatry
Division name Department of Mental Disorder Research, National Institute of Neuroscience
Zip code
Address 4-1-1, Ogawa-Higashi, Kodaira, Tokyo
TEL 0423412712
Email hkunugi@ncnp.go.jjp

Public contact
1st name of contact person
1st name
Middle name
Last name Miho Ota
Organization National Center of Neurology and Psychiatry
Division name Department of Mental Disorder Research, National Institute of Neuroscience
Zip code
Address 4-1-1, Ogawa-Higashi, Kodaira, Tokyo
TEL 0423412712
Homepage URL http://www.ncnp.go.jp/nin/guide/r3/index.html
Email ota@ncnp.go.p

Sponsor
Institute the ethics committee of the National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization Comissive research funding from the food science institute foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor The food science institute foundation
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 国立精神・神経医療研究センター(東京都)

Other administrative information
Date of disclosure of the study information
2014 Year 08 Month 01 Day

Related information
URL releasing protocol http://www.ncnp.go.jp/nin/guide/r3/index.html
Publication of results Unpublished

Result
URL related to results and publications http://www.ncnp.go.jp/nin/guide/r3/index.html
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 Open public recruiting
Date of protocol fixation
2013 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date
2013 Year 12 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2016 Year 03 Month 31 Day
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 07 Month 25 Day
Last modified on
2019 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017045

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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