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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037349
Receipt No. R000042576
Scientific Title An evaluation study of free fatty acid by intake of test food
Date of disclosure of the study information 2019/07/31
Last modified on 2019/10/01

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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

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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