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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030691
Receipt No. R000034916
Scientific Title Study on the accumulation of AGEs by test food intake
Date of disclosure of the study information 2018/01/09
Last modified on 2018/08/01

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Basic information
Public title Study on the accumulation of AGEs by test food intake
Acronym Study on the accumulation of AGEs by test food intake
Scientific Title Study on the accumulation of AGEs by test food intake
Scientific Title:Acronym 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
1st name
Middle name
Last name Yoshikazu Yonei
Organization Doshisha University
Division name Graduate School of Life and Medical Sciences
Zip code
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
1st name
Middle name
Last name Toshiyasu Tamura
Organization TES Holdings Co., Ltd.
Division name Department of Clinical Trial
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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
2017 Year 12 Month 11 Day
Date of IRB
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

Other
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

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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