UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Solubilized medium-chain triacylglycerols on energy metabolism
Acronym	Effect of Solubilized medium-chain triacylglycerols on energy metabolism
Scientific Title	Effect of Solubilized medium-chain triacylglycerols on energy metabolism
Scientific Title:Acronym	Effect of Solubilized medium-chain triacylglycerols on energy metabolism
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to investigate the effects of the test meal on exercise performance and energy metabolism of healthy adults have regular exercise habits.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood sugar level, blood ketone body, lactic acid level, respiratory quotient, the mileage
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	To take a supplement, if necessary with water.
Interventions/Control_2	To take a placebo, if necessary with water.
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	39 years-old >=
Gender	Male
Key inclusion criteria	1.Japanese male aged 20-39 at the screening visit. 2.Healthy adults.(no serious disease by self-report). 3.Those who do regular exercise habits. 4.Those who are able to sign an informed consent, after fully informed the purpose and contents of the study. 5.Those who are able to come to the hospital on the day of the study.
Key exclusion criteria	1.Those with serious or progressive diseases and symptoms, those with motor function disorders. 2.Currently under medications. 3.Severely damaged exerciser such as bone fracture, tendon rupture, muscle tear in the past year. 4.Those who are stopped to exercise by a doctor. 5.Those who do weight training everyday. 6.Smokers or those who quit smoking for less than 1 year. 7.Those who drink alcohol on the day before the study visit. 8.Those who with an abnormality in the blood test value at the time of screening, except for judged by the Principal doctor as physiological fluctuation range. 9.Those who are participated in other clinical trials within a month before the screening test. 10.Those who with any food or medicine allergies. 11.Those who judged to be inappropriate for participating in the study by Principal Investigator (or other doctor).
Target sample size	4

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yuki Kamioka
Organization	NOF CORPORATION
Division name	FUNCTIONAL FOODS RESEARCH LABORATORY 3GROUP
Zip code
Address	3-3 CHIDORI-CHO,KAWASAKI-KU,KAWASAKI,KANAGAWA ,JAPAN
TEL	044-281-2502
Email	yuki_kamioka@nof.co.jp

Public contact
Name of contact person	1st name Middle name Last name Yuki Kamioka
Organization	NOF CORPORATION
Division name	FUNCTIONAL FOODS RESEARCH LABORATORY 3GROUP
Zip code
Address	3-3 CHIDORI-CHO,KAWASAKI-KU,KAWASAKI,KANAGAWA ,JAPAN
TEL	044-281-2502
Homepage URL
Email	yuki_kamioka@nof.co.jp

Sponsor
Institute	NOF CORPORATION
Institute
Department

Funding Source
Organization	NOF CORPORATION
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
Address
Tel
Email

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	2018 Year 03 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	Completed
Date of protocol fixation	2018 Year 01 Month 23 Day
Date of IRB
Anticipated trial start date	2018 Year 03 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 01 Day
Last modified on	2018 Year 03 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036002

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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