UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination on an influence of continuous intake of a test food product on Toxic AGEs (TAGEs) in blood
Title of the study (Brief title)	Examination on an influence of continuous intake of a test food product on Toxic AGEs (TAGEs) in blood
Region	Japan

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

Objectives
Narrative objectives1	To examine an influence of a test food product on Toxic AGEs (TAGEs) in blood by selecting males aged 30 and over, below 65 as subjects and assigning them to take the test food product for 8 weeks on a continuous basis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Toxic AGEs (TAGEs) in blood
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	30 years-old <=
Age-upper limit	65 years-old >
Gender	Male
Key inclusion criteria	1.Age: 30 or over, below 65 2.Sex: Males
Key exclusion criteria	1.Currently in treatment with medication or currently seeing a doctor for treatment of severe disorder 2.Possible allergic reaction to the test food product 3.Current administration of medication with a possible influence on the study 4.Received vaccination in the past three months or desired to receive vaccination during a study period 5.Extreme faddiness 6.Extremely irregular lifestyle habits such as eating and sleeping habits 7.Current participation in any other clinical study or participation in other clinical study in the past three months 8.Determined by the investigator to be unsuitable for enrollment in this study
Target sample size	12

Research contact person
Name of lead principal investigator	Matsuoka Masao
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Address	Oekkusu Bldg.10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	81-3-3431-1260
Email	matsuoka@huma-c.co.jp

Public contact
Name of contact person	Matsuoka Masao
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Address	Oekkusu Bldg.10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	81-3-3431-1260
Homepage URL
Email	matsuoka@huma-c.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 03 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 13 Day
Anticipated trial start date	2017 Year 10 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2017 Year 10 Month 23 Day
Last modified on	2018 Year 04 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033912