UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049166 |
|---|---|
| Receipt number | R000055997 |
| Scientific Title | A study of whether medium-chain fatty acids (MCTs) are effective at breakfast or dinner. |
| Date of disclosure of the study information | 2022/10/09 |
| Last modified on | 2022/10/09 19:35:17 |
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Basic information
Public title
A study of whether medium-chain fatty acids (MCTs) are effective at breakfast or dinner.
Acronym
Influence of medium-chain fatty acid intake time on muscle function and memory.
Scientific Title
A study of whether medium-chain fatty acids (MCTs) are effective at breakfast or dinner.
Scientific Title:Acronym
Influence of medium-chain fatty acid intake time on muscle function and memory.
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the duration of intake of medium-chain fatty acids affects the improvement of muscle strength and memory in healthy subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body composition, Physical ability, Concentration and memory tests
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The first group is the "breakfast group" in which 18g of MCT(10:0) is taken after breakfast for one month.
Interventions/Control_2
The second group is the "dinner group" in which 18g of MCT(10:0) is taken at dinner for one month.
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
| 20 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy people between 20 and 25 years old
Key exclusion criteria
(1)Subjects with type 1 diabetes, serious heart disease, liver disease, renal disease, blood disease, etc.
(2)Persons with a BMI of 24.0 kg/m2 or more.
(3)Subjects with applicable food allergies.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Sakiko |
| Middle name | |
| Last name | Abe |
Organization
Tezukayama University
Division name
Faculty of Contemporary Human Life Studies, Department of Food and Nutrition
Zip code
631-8585
Address
3-1-3 Gakuenminami, nara-shi, nara-ken
TEL
0742-41-4742
sa-abe@tezukayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Sakiko |
| Middle name | |
| Last name | Abe |
Organization
Tezukayama University
Division name
Faculty of Contemporary Human Life Studies, Department of Food and Nutrition
Zip code
631-8585
Address
3-1-3 Gakuenminami, nara-shi, nara-ken
TEL
0742-41-4742
Homepage URL
sa-abe@tezukayama-u.ac.jp
Sponsor or person
Institute
Tezukayama University
Institute
Department
Personal name
Funding Source
Organization
Tezukayama University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tezukayama University
Address
3-1-3 Gakuenminami, nara-shi, nara-ken
Tel
0742-41-4742
sa-abe@tezukayama-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
04-20
Org. issuing International ID_1
Tezukayama University, Medical Research Ethics Review for Human Subjects
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 10 | 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
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 09 | Day |
Last modified on
| 2022 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055997
