UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of the Effect of Continuous Intake of test food on Blood Epidermal Growth Factor (EGF)
Title of the study (Brief title)	Investigation of the Effect of Continuous Intake of test food on Blood Epidermal Growth Factor (EGF)
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study was to investigate the effect of the test food on blood Epidermal Growth Factor (EGF) by continuously ingesting the test food for 8 weeks in men aged 20 years or older and younger than 65 years.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood Epidermal Growth Factor (EGF)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	8-week intake of the test food
Interventions/Control_2
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	65 years-old >
Gender	Male
Key inclusion criteria	1. Age: 20 years or older, less than 65 years 2. Male gender
Key exclusion criteria	1. Patients who are currently receiving medication or outpatient treatment due to a serious disease. 2. Persons who are likely to develop allergies to test food 3. Subjects taking medications that may affect the study 4. Persons engaging in extreme prey 5. Extremely irregular lifestyle such as eating and sleeping 6. Subjects who are currently participating in other clinical trials or have participated in other clinical trials within the past 3 months. 7. Other persons for whom the principal Doctor in charge of examination judges it inappropriate for the study.
Target sample size	4

Research contact person
Name of lead principal investigator	Matsuoka Masao
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	03-3431-1260
Email	matsuoka@huma-rd.co.jp

Public contact
Name of contact person	Matsuoka Masao
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	03-3431-1260
Homepage URL
Email	matsuoka@huma-rd.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	Toyo Sugar Refining Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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 10 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 09 Month 14 Day
Anticipated trial start date	2018 Year 10 Month 19 Day
Last follow-up date	2018 Year 12 Month 14 Day
Date of closure to data entry	2018 Year 12 Month 25 Day
Date trial data considered complete	2018 Year 12 Month 25 Day
Date analysis concluded	2019 Year 01 Month 08 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 10 Month 09 Day
Last modified on	2019 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039249