UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033447 |
|---|---|
| Receipt number | R000038140 |
| Scientific Title | The effect of MCT oil on cognitive function and neural basis of the elderly |
| Date of disclosure of the study information | 2018/07/23 |
| Last modified on | 2021/04/07 13:00:33 |
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Basic information
Public title
The effect of MCT oil on cognitive function and neural basis of the elderly
Acronym
MCT SMILE project
Scientific Title
The effect of MCT oil on cognitive function and neural basis of the elderly
Scientific Title:Acronym
MCT SMILE project
Region
| Japan |
Condition
Condition
Mild Cognitive Impairment
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The MCT oil, known as included in coconut oil, was traditionally used in medication for dyslipidemia and epilepsy. Moreover, its effects on the cognitive function of the elderly and body fat volume are revealed in recent studies.
The aim of this study is to elucidate the neural basis and biological background of such effects.
Cognitive healthy or mild impaired elderly people asked to intake MCT oil for 3 months. We compare the changes in cognitive function, glucose metabolism, cerebral blood flow, brain morphology, and body composition using PET-CT and MRI.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
3-month change in ADAS-Jcog score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Patients are asked to intake the MCT containing food, yogurt flavored jelly type one, for 3 months.
MCT oil 15g/package, 6g MCT oil contained
start with 1package/day and increase the dose if there is no severe adverse effect.
1st week : MCT 6g= 1 package/day
2nd week : MCT 12g= 2 package/day
3rd-12th week: MCT 18g= 3 package/day
Interventions/Control_2
Participants in control group take testing food which MCT is replaced with LCT (canola oil).
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Cognitive healthy or mild cognitive impaired elderly people
(2) Cognitivi function (both)
Mini Mental State Examinaton (MMSE) 24points or more
Clinical Dementia Rating (CDR) 0~0.5points
(3) Performance Status:0-1
(4) Age: 60-80 years old
(5) Male and Female
(6) Right handed patient admitted to Tohoku University Hosipital from April 2018 on
Key exclusion criteria
(1) Severe past history of brain, psychologycal disease
(2) Clinical hemophilic arthritis
(3) Liver disease accompanying coagulopathy
(4) Metalic implant (pace maker, coronaly stent, artificial joint, etc.)
(5) Claustrophobia
(6) Diabetes Mellitus (FBG<100 mg/dL)
(7) Depression
(8) Severe visual and hearing disturbance
(9) Muscular disease
(10) Excessive obesity/slimming (BMI <17, >30)
(11) Kidney Disease (CCr <15 mL/min)
(12) Problem with digention or metabolism
(13) Psychotic dysorder
(14) Do not (cannot) concent to this study
(15) Who assessed as not suitable for this study by conducting doctors
Target sample size
65
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Taki |
Organization
Depertment of nuclear medicine and Radiology
Division name
IDAC, Tohoku University
Zip code
980-8575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575 JAPAN
TEL
022-717-8559
yasuyuki.taki.c7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Tatsushi |
| Middle name | |
| Last name | Mutoh |
Organization
Depertment of nuclear medicine and Radiology
Division name
IDAC, Tohoku University
Zip code
980-8575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575 JAPAN
TEL
022-717-8559
Homepage URL
tmutoh@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
The Nisshin OilliO Group, Ltd.
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
The Nisshin OilliO Group, Ltd.
Kousei Sendai Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Hospital IRB
Address
2-1 Seiryo-mchi, Aoba-ku, Sendai
Tel
0227284105
rinri-2@proj.med.tohoku.ac.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 23 | 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 | 07 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 19 | Day |
Last modified on
| 2021 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038140
