UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031539
Receipt number R000035998
Scientific Title Assessment of brain mechanisms underlying effect of a ketogenic meal on cognitive function
Date of disclosure of the study information 2018/03/01
Last modified on 2019/03/04 15:54:03

* 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

Assessment of brain mechanisms underlying effect of a ketogenic meal on cognitive function

Acronym

Assessment of brain mechanisms underlying effect of a ketogenic meal on cognitive function

Scientific Title

Assessment of brain mechanisms underlying effect of a ketogenic meal on cognitive function

Scientific Title:Acronym

Assessment of brain mechanisms underlying effect of a ketogenic meal on cognitive function

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We aim to assess brain mechanisms underlying possible cognitive enhancement effect of a ketogenic meal in healthy elderly participants. Cognitive tests and neuroimaging methods are employed for that purpose. Also, the possible link between brain morphology and sensitivity to cognitive enhancement effect is assessed.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1. Changes in brain activation related to cognitive enhancement by a ketogenic meal
2. Brain morphology related to individual difference in sensitivity to cognitive enhancement effect by a ketogenic meal

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

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

A single serving of the ketogenic meal consisted of 50 g of Meiji817-B (Meiji Co., Ltd., Tokyo, Japan), which contains 20 g of medium chain triglycerides.

Interventions/Control_2

A single serving of the 50 g placebo meal containing the same ingredients as Meiji817-B except that medium chain triglycerides is substituted by long chain triglycerides.

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

75 years-old >

Gender

Male and Female

Key inclusion criteria

Elderly people who is between 60 and 75 years old

Key exclusion criteria

1. Left-handedness
2. History of psychiatric illnesses
3. History of significant head trauma or neurological disorders
4. Any medical condition that could affect brain function/morphology
5. Pregnancy
6. Any contraindication to MRI scanning (e.g. metal implants, cardiac pace-maker)
7. People who don't want to be informed of incidental findings
8. Allergies to milk, soybean, or pork
9. Lactose intolerance
10. Any other person whom the principal investigator has determined to be unsuitable as a participant of the study.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi 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, Japan

TEL

042-341-2711

Email

hkunugi@ncnp.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yukihito Yomogida

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, Japan

TEL

042-341-2711

Homepage URL


Email

yomogida@ncnp.go.jp


Sponsor or person

Institute

National Center of Neurology and Psychiatry

Institute

Department

Personal name



Funding Source

Organization

The Food Science Institute Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor

Meiji Holdings Co., Ltd.

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

2018 Year 03 Month 01 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

2018 Year 02 Month 08 Day

Date of IRB


Anticipated trial start date

2018 Year 03 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

2018 Year 03 Month 01 Day

Last modified on

2019 Year 03 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035998


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name