UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045970 |
|---|---|
| Receipt number | R000052470 |
| Scientific Title | Exploratory study on effects of continuous intake of food containing medium-chain triglycerides on maintaining and improving health in elderly people |
| Date of disclosure of the study information | 2021/11/03 |
| Last modified on | 2023/02/22 16:07:00 |
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Basic information
Public title
Effects of medium-chain triglycerides intake on mental health in elderly people
Acronym
Medium-chain triglycerides and elderly mental health
Scientific Title
Exploratory study on effects of continuous intake of food containing medium-chain triglycerides on maintaining and improving health in elderly people
Scientific Title:Acronym
Study on medium-chain triglycerides intake and elderly health
Region
| Japan | Asia(except Japan) |
Condition
Condition
Healthy elderly
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effects of continuous intake of low-dose medium-chain triglycerides on mental health in healthy elderly.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function(Trail Making Test, Stroop Test, Brief Assessment of Cognition in Schizophrenia)
at baseline and after 12 weeks administration
Key secondary outcomes
1.Mini Mental State Examination
2.Beck Depression Inventory, State-Trait Anxiety Inventory, Hopkins Symptoms Checklist, Pittsburgh Sleep Quality Index
3.body weight, body mass index, skeletal muscle mass index, handgrip strength
4.blood inflammatory marker (C-reactive protein) milligram/dl
5.blood metabolites [medium-chain triglycerides(caprylic acid, capric acid), ketone bodies(beta-hydroxybutyric acid, acetoacetic acid)] microgram/ml
6.blood metabolic marker (ghrelin, des-acyl ghrelin, insulin-like growth factor-1,brain-derived neurotrophic factor) femtomol/ml
at baseline and after 12 weeks administration
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
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Medium-chain triglycerides (dose 1) once a day for 12 weeks
Interventions/Control_2
Medium-chain triglycerides (dose 2) once a day for 12 weeks
Interventions/Control_3
Long-chain triglycerides (control) once a day for 12 weeks
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
People with a score of 24 or more in the Mini-Mental State Examination
Key exclusion criteria
1.Patients with dementia
2.Patients being treated for diabetes mellitus, brain or heart diseases, and psychiatric disorders
3.People who are diagnosed with psychiatric disorders in the Mini-International Neuropsychiatric Interview
4.People who are on a low-carbohydrate diet or a ketogenic diet
5.People who daily take medicines or healthy foods that may affect cognitive function
6.People who daily take medium-chain triglycerides or coconut oil
7.People who have food allergies for milk or soybeans
8.People with lactose intolerance
9.People who have difficulty performing cognitive function and mental health tests
10.People with significant abnormalities in physical and blood tests
11.People who are positive for infectious diseases in blood test
12.People with 30 or more body mass index
13.People who participated in other clinical trials within 1 month before the start of this study, or people who plan to participate in other clinical studies within 12 weeks after the start of this study
14.People who are judged to be inappropriate by principal investigator
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kunugi |
Organization
Teikyo University School of Medicine
Division name
Department of Psychiatry
Zip code
173-8605
Address
2-11-1, Kaga, Itabashi-ku, Tokyo
TEL
03-3964-1462
hkunugi@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Akari |
| Middle name | |
| Last name | Takeuchi |
Organization
Teikyo University School of Medicine
Division name
Department of Psychiatry
Zip code
173-8605
Address
2-11-1, Kaga, Itabashi-ku, Tokyo
TEL
03-3964-1462
Homepage URL
takeuchi.a@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Funding Source
Organization
Food Research Group
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Meiji Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo University Ethical Review Board for Medical and Health Research Involving Human Subjects
Address
2-11-1, Kaga, Itabashi-ku, Tokyo
Tel
03-3964-7256
turb-office@teikyo-u.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
| 2021 | Year | 11 | Month | 03 | 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
| 2021 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 03 | Day |
Last modified on
| 2023 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052470
