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
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
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
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
