UMIN-CTR Clinical Trial

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
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 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
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	3-1-3 Gakuenminami, nara-shi, nara-ken
Tel	0742-41-4742
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055997