UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014651 |
|---|---|
| Receipt number | 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 12:07:28 |
* 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
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
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
ota@ncnp.go.p
Sponsor or person
Institute
the ethics committee of the National Center of Neurology and Psychiatry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017045
