UMIN-CTR Clinical Trial

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
Email	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
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	Tohoku University Hospital IRB
Address	2-1 Seiryo-mchi, Aoba-ku, Sendai
Tel	0227284105
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038140