UMIN-CTR Clinical Trial

Recruitment status Completed
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 2019/08/01 (Ver. 6)

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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
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Kunugi
Organization National Center of Neurology and Psychiatry
Division name Department of Mental Disorder Research, National Institute of Neuroscience
Zip code 187-8502
Address 4-1-1, Ogawa-Higashi, Kodaira, Tokyo
TEL 0423412712
Email hkunugi@ncnp.go.jjp

Public contact
Name of contact person
1st name Miho
Middle name
Last name Ota
Organization National Center of Neurology and Psychiatry
Division name Department of Mental Disorder Research, National Institute of Neuroscience
Zip code 187-8502
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 National Center of Neurology and Psychiatry
Address 4-1-1, Ogawa-Higashi, Kodaira, Tokyo
Tel 0423412711
Email ota@ncnp.go.jp

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 Published

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 20
Results 
Twenty patients with AD underwent neurocognitive tests before and after intake of a ketogenic formula. These patients took the ketogenic formula daily for up to 12 weeks, and underwent neurocognitive tests. After the single intake, there was no significant difference, but after the chronic intake of the ketogenic formula, they showed significant improvements in the digit symbol coding test and immediate logical memory test compared with baseline.
Results date posted
2019 Year 08 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Subjects were 20 patients (11 males; mean age: 73.4 years) who were diagnosed
with AD according to the criteria of the NINCDS/ADRDA.
Participant flow 
All 20 of these　patients participated in the first trial of this study, which examined the possible effect of　a single administration of ketogenic formula on cognitive function. For the second trial,　which was a longitudinal, open-label 12-week trial, 19 of the 20 patients gave their
consent to participate, and 3 dropped out prior to the end of the 12-week administration　period.
Adverse events 
Three dropped out prior to the end of the 12-week administration　period　due to diarrhea.
Outcome measures 
Immediate logical memory, delayed logical memory, digit span and visual memory span
tests from the Wechsler Memory Scale-Revised, block-design and digit　symbol coding tests from the Wechsler Adult Intelligence Scale-3rd,　the Stroop test and the Trail Making Test.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 10 Month 30 Day
Date of IRB
2014 Year 09 Month 19 Day
Anticipated trial start date
2014 Year 11 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 08 Month 01 Day


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