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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033447
Receipt No. 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 2019/01/18

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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 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taki Yasuyuki
Organization Depertment of nuclear medicine and Radiology
Division name IDAC, Tohoku University
Zip code
Address 4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575 JAPAN
TEL 022-717-8559
Email yasuyuki.taki.c7@tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mutoh Tatsushi
Organization Depertment of nuclear medicine and Radiology
Division name IDAC, Tohoku University
Zip code
Address 4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575 JAPAN
TEL 022-717-8559
Homepage URL
Email tmutoh@tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

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
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 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 Open public recruiting
Date of protocol fixation
2018 Year 07 Month 19 Day
Date of IRB
Anticipated trial start date
2018 Year 09 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 07 Month 19 Day
Last modified on
2019 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038140

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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