UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of brain mechanisms underlying effect of a ketogenic meal on cognitive function
Title of the study (Brief title)	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	Hiroshi Kunugi
Organization	National Center of Neurology and Psychiatry
Division name	Department of Mental Disorder Research, National Institute of Neuroscience
Address	4-1-1, Ogawa-Higashi, Kodaira, Tokyo, Japan
TEL	042-341-2711
Email	hkunugi@ncnp.go.jp

Public contact
Name of contact person	Yukihito Yomogida
Organization	National Center of Neurology and Psychiatry
Division name	Department of Mental Disorder Research, National Institute of Neuroscience
Address	4-1-1, Ogawa-Higashi, Kodaira, Tokyo, Japan
TEL	042-341-2711
Homepage URL
Email	yomogida@ncnp.go.jp

Sponsor
Institute	National Center of Neurology and Psychiatry
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035998