UMIN-CTR Clinical Trial

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
Email	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
Email	sa-abe@tezukayama-u.ac.jp

Sponsor
Institute	Tezukayama University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052302