UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030691 |
|---|---|
| Receipt number | 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 12:34:16 |
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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
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
info@tes-h.co.jp
Sponsor or person
Institute
Anti-Aging Bank Co.,Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034916
