UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055370 |
|---|---|
| Receipt number | R000063280 |
| Scientific Title | The relationship between acute and chronic impacts of Medium Chain Triglyceride on cognitive function in young individuals? |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2025/01/24 12:39:50 |
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Basic information
Public title
Could Medium Chain Triglyceride improve cognitive function even in young individuals?
Acronym
Medium Chain Triglyceride and cognitive function
Scientific Title
The relationship between acute and chronic impacts of Medium Chain Triglyceride on cognitive function in young individuals?
Scientific Title:Acronym
ketone body and cognitive function
Region
| Japan |
Condition
Condition
Healthy young individuals
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will examine whether a single intake and/or habitual intake of medium-chain triglyceride improve cognitive function in healthy individuals.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
We will measure cognitive function in response to 1 day and/or 28 days of medium-chain triglyceride consumptions
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Medium Chain Triglyceride
Interventions/Control_2
Long Chain Triglyceride
Interventions/Control_3
Medium Chain Triglyceride + Exercise
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
| 18 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy individuals
Key exclusion criteria
Non-smoker
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hayato |
| Middle name | |
| Last name | Tsukamoto |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
04-2947-6772
hayato.tsukamoto@aoni.waseda.jp
Public contact
Name of contact person
| 1st name | Hayato |
| Middle name | |
| Last name | Tsukamoto |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
04-2947-6772
Homepage URL
hayato.tsukamoto@aoni.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the promotion of science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ritsumeikan University Ethics Review Committee for Research Involving Human Participants
Address
1-1-1 Nojihigashi, Kusatsu, Shiga
Tel
077-599-4175
b-rinri@st.ritsumei.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
| 2024 | Year | 09 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
| 2025 | Year | 01 | Month | 20 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 30 | Day |
Last modified on
| 2025 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063280
