UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the accumulation of AGEs by test food intake
Title of the study (Brief title)	Study on the accumulation of AGEs by test food intake
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is accumulation of AGEs by test food intake and verification of safety. Have a healthy woman aged between 50 and 70 take a test food for 4 weeks. The accumulation of AGEs and safety of it will be verified in a single blind group comparison test with placebo food as a control.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Accumulation of AGEs(Fluorescent AGEs,CML, Pentosidine)
Key secondary outcomes	Safety(Blood biochemistry etc.)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Oral ingestion of the test product A(4 weeks)
Interventions/Control_2	Oral ingestion of the test product B(4 weeks)
Interventions/Control_3	Oral ingestion of the control product(4 weeks)
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	50 years-old <=
Age-upper limit	70 years-old >
Gender	Female
Key inclusion criteria	[1]Japanese females aged 50-69 years [2]Healthy individuals not receiving any medical disease treatment [3]Individuals voluntarily join the study with written informed consent [4]Individuals who can have an examination on a designated check day [5]Individuals judged appropriate to join this study by principal investigators
Key exclusion criteria	[1]Individuals using medical products [2]Individuals with skin disease,such as atopic dermatitis [3]Individuals who have an inflammation or a scar on a measuring area [4]Individuals under treatment or with history of mental disorders, sleep disorders,hypertension,diabetes,lipid metabolism abnormality,or other serious disorders [5]Individuals receiving/received medical drug treatment for the past 1 month except for temporary relief medication for headache,menstrual pain,common cold,etc. [6]Individuals with history of serious diseases (hepatic,renal,cardiovascular,respiratory,hematologic,etc.) [7]Individual who have digestive organ disease [8]Individuals donated blood >200ml in past 1 month or >400ml in past 3 months [9]Individual who have experienced mood disorder or physical condition deterioration due to blood sampling in the past [10] Individuals deemed sensitive to the test product or highly allergic to foods or medical drugs [11]Currently,health food,supplements with continuous ingestion habits,individuals who intend to intake during the examination period (but not those who can stop taking the intake at the time of consent acquisition) [12]Individuals with alcohol intake exceeding 60g/day,as ethanol volume [13]Individuals who may significantly change exercise habit or lifestyle during the study period(ex. travel for a long time) [14]Pregnant or lactating women (expected,desired inclusive) [15]Individuals who will get sunburned during the test period etc. [16]Individuals participating or planning to join the other clinical investigations during the study period [17]Individual with potential conflict of interests [18]Individuals judged inappropriate for the study by the principal
Target sample size	24

Research contact person
Name of lead principal investigator	Yoshikazu Yonei
Organization	Doshisha University
Division name	Graduate School of Life and Medical Sciences
Address	1-3 Tatara Miyakodani Kyotanabe City Kyoto, 610-0394, Japan
TEL	0774-65-6394
Email	yyonei@mail.doshisha.ac.jp

Public contact
Name of contact person	Toshiyasu Tamura
Organization	TES Holdings Co., Ltd.
Division name	Department of Clinical Trial
Address	6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL	03-6801-8480
Homepage URL
Email	info@tes-h.co.jp

Sponsor
Institute	Anti-Aging Bank Co.,Ltd.
Institute
Department

Funding Source
Organization	Sunsho Pharmaceutical 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	一般社団法人オリエンタル労働衛生協会東京支部　オリエンタル上野健診センター（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 11 Day
Anticipated trial start date	2018 Year 01 Month 10 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	2018 Year 01 Month 05 Day
Last modified on	2018 Year 08 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034916