UMIN-CTR Clinical Trial

Basic information
Public title	An evaluation study of free fatty acid by intake of test food
Acronym	An evaluation study of free fatty acid by intake of test food
Scientific Title	An evaluation study of free fatty acid by intake of test food
Scientific Title:Acronym	An evaluation study of free fatty acid by intake of test food
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to examine the influence of the intake of the test food on free fatty acid concentration in blood in men aged 20 to 40 years old and BMI >=18.5 kg/m2 and <25 kg/m2.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Free fatty acid
Key secondary outcomes	Adverse event

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	Take test food on the day of the test Wash out Take placebo food on the day of the test
Interventions/Control_2	Take placebo food on the day of the test Wash out Take test food on the day of the test
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	40 years-old >
Gender	Male
Key inclusion criteria	1)Japanese male aged 20 to 40 years of age at the time of the informed consent. 2)Subject with BMI>=18.5 kg/m2 and <25 kg/m2. 3)Subject who has understood the purpose of the study,and agreed to participate it by signing the written informed consent.
Key exclusion criteria	1)Subject who drinks a lot of alcohol. 2)Subject who has a smoking habit. 3)Subject who is taking medication or under medical treatment because of some serious illness. 4)Subject who is under exercise therapy or dietetic therapy. 5)Subject who has an allergy for test food. 6)Subject who has or had a history of either medicine or alcohol dependence syndrome. 7)Subject who has or had a history of mental illness (depression) or sleep disturbance. 8)Subject who is on a night-shift or is a shift worker. 9)Subject whose lifestyle is extremely irregular. 10)Subject who has an unbalanced diet. 11)Subject who is current disease or history of diabetes, liver disease (hepatitis), kidney disease, serious disease such as heart disease, thyroid disease, adrenal disease, other metabolic diseases. 12)Subject who uses health foods and supplements that affect lipid metabolism. 13)Subject who takes medications continuously and can not stop taking them during the study period. 14)Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study. 15)Subject who has blood drawn 200mL within the past 1 months or 400mL within the past 3 months from the day of the consent acquisition. 16)Subject who can't keep the daily records. 17)In addition, subject who judged a study responsibility physician to be inadequate as an object of this study.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Daisuke Middle name Last name Ochitani
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Zip code	108-0014
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	03-3431-1260
Email	ochitani@huma-rd.co.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Ochitani
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Zip code	108-0014
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	03-3431-1260
Homepage URL
Email	ochitani@huma-rd.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	Asahi Quality and Innovations Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committees of Nihonbashi Egawa Clinic
Address	2F Kotobuki Build. 1-1-3 Yaesu Chuo-ku, Tokyo 103-0028 Japan
Tel	03-5204-0311
Email	jim@medipharma.co.jp

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	2019 Year 07 Month 31 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	10
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	2019 Year 06 Month 14 Day
Date of IRB	2019 Year 06 Month 17 Day
Anticipated trial start date	2019 Year 07 Month 10 Day
Last follow-up date	2019 Year 08 Month 06 Day
Date of closure to data entry	2019 Year 08 Month 08 Day
Date trial data considered complete	2019 Year 08 Month 30 Day
Date analysis concluded	2019 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date	2019 Year 07 Month 12 Day
Last modified on	2019 Year 10 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042576