UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045834 |
|---|---|
| Receipt number | R000052302 |
| Scientific Title | Differences in efficacy of medium-chain fatty acids (MCTs) depending on the number of carbon atoms (8: 0, 10: 0). |
| Date of disclosure of the study information | 2021/10/23 |
| Last modified on | 2021/10/22 20:27:36 |
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Basic information
Public title
Differences in efficacy of medium-chain fatty acids (MCTs) depending on the number of carbon atoms (8: 0, 10: 0).
Acronym
Is there a difference in the number of carbon atoms (8: 0, 10: 0) of medium-chain fatty acids (MCTs).
Scientific Title
Differences in efficacy of medium-chain fatty acids (MCTs) depending on the number of carbon atoms (8: 0, 10: 0).
Scientific Title:Acronym
Is there a difference in the number of carbon atoms (8: 0, 10: 0) of medium-chain fatty acids (MCTs).
Region
| Japan |
Condition
Condition
Nomal
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the difference in efficacy depending on the carbon number of medium-chain fatty acids.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in muscle strength, muscle function, memory, and concentration are compared before and after the intervention for 1 month and 0.5 months after the end of the intervention.
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 |
Interventions/Control_1
The MCT (8:0) group ingests 6 g of commercially available MCT every meal (morning, lunch, and dinner) every day for one month.
Interventions/Control_2
The MCT (10:0) group ingests 6 g of commercially available MCT every meal (morning, lunch, and dinner) every day for one month.
Interventions/Control_3
The LCT group ingests 6 g of commercially available LCT every meal (morning, lunch and dinner) every day for one month.
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 individuals in their early twenties who received sufficient explanation about the purpose and content of this study and agreed.
Key exclusion criteria
(1) People with type I diabetes, serious heart disease, liver disease, kidney disease, blood disease, etc.
(2) Body mass index (BMI) 23.0 kg / m2 or more.
(3) Persons 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 Life Studies, Department of Food and Nutrition
Zip code
631-8585
Address
Gakuenminami 3-1-3, 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 Life Studies, Department of Food and Nutrition
Zip code
631-8585
Address
Gakuenminami 3-1-3, 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
Gakuenminami 3-1-3, nara-shi, nara-ken
Tel
0742-41-4742
sa-abe@tezukayama-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
03-18
Org. issuing International ID_1
Tezukayama University Human Research Ethics Committee
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 | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 22 | Day |
Last modified on
| 2021 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052302
