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

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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 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

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

Value
https://center6.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