UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042184 |
|---|---|
| Receipt number | R000048122 |
| Scientific Title | Test of re-verification of blood AGEs lowering effect (CML, 3-DG) and evaluation of effectiveness to the skins by intake of test food for 12 weeks |
| Date of disclosure of the study information | 2020/10/22 |
| Last modified on | 2021/10/25 09:42:58 |
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Basic information
Public title
Test of re-verification of blood AGEs lowering effect (CML, 3-DG) and evaluation of effectiveness to the skins by intake of test food for 12 weeks
Acronym
Test of re-verification of blood AGEs lowering effect and evaluation of effectiveness to the skins by intake of test food for 12 weeks
Scientific Title
Test of re-verification of blood AGEs lowering effect (CML, 3-DG) and evaluation of effectiveness to the skins by intake of test food for 12 weeks
Scientific Title:Acronym
Test of re-verification of blood AGEs lowering effect and evaluation of effectiveness to the skins by intake of test food for 12 weeks
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate of blood AGEs lowering effect and effectiveness and safety to the skins by continuous intake of test food
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood AGEs(CML, 3-DG, pentosidine, MRX)
Key secondary outcomes
facial image analysis, trans-epidermal water loss(TEWL),
horny layer water content, skin viscoelasticity, collect of horny layer (analysis of cell area, multiple peeling, carbonylated protein), questionnaire (changes in skin condition, impression of ingesting test food)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of test food 3 times a day for 12 weeks
Interventions/Control_2
Intake of placebo 3 times a day for 12 weeks
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
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
(1)30 to 60 years old at the time of consent
(2)Persons who are concerned about skin quality of face(self-reported)
(3)Persons who can voluntarily consent to participate in the study by consent form
Key exclusion criteria
(1)Having or suspected of having osteoporosis
(2)Those who visit the hospital with s skin disease
(3)Those who were judged to require treatment with liver function, renal function, glucose metabolism
(4)Taking foods and supplements including Vitamin E and using cosmetics, quasi-drugs, health foods, foods (ex. indicating to anti-ageing effect, antioxidant effect) regularly
(5)Having atopic dermatitis, urticarial, inflammation, eczema, trauma, acne, warts, age spots at the evaluation area
(6)Having a experience of receiving aesthetic medicine or plan to receive during the test
(7)Those who have received or plan to receive special skin care treatments at the evaluation area within the past 4 weeks
(8)Those who have changed or started using health foods, basic cosmetics and sunscreens at the evaluation area within the past 4 weeks
(9)Those who have been exposed to UV light beyond their daily lives within the past 4 weeks or who plan to do so during the test period
(10)Night-shift and/or day-shift workers
(11)Those who are receiving treatment at medical institutions or those who are judged to be in need of treatment
(12)Having a history of serious or psychiatric disorders of glucose metabolism, lipid metabolism, liver function, renal function, heart, cardiovascular system, respiratory system, endocrine system, immune system, nervous system
(13)Having a history of alcohol and drug addicts
(14)Having a risk of developing allergies to cosmetics and foods(especially almonds)
(15)Pregnant and nursing woman and those who wish to become pregnant during the test period
(16)Taking part in another test and having plan to take part in another test within the past 4 weeks
(17)Those who are judged not suitable to participate in this test by physician(or examiner)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kawabata |
Organization
EZAKI GLICO Co., Ltd
Division name
R&D LABORATORY
Zip code
555-8502
Address
4-6-5, Utajima, NIshiyodogawa-ku, Osaka
TEL
06-6477-8793
hiroshi.kawabata@glico.com
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Iizuka |
Organization
EZAKI GLICO Co., Ltd.
Division name
R&D LABORATORY
Zip code
555-8502
Address
4-6-5, Utajima, NIshiyodogawa-ku, Osaka
TEL
06-6477-8793
Homepage URL
hiroyuki.iizuka@glico.com
Sponsor or person
Institute
EZAKI GLICO Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Brain Care Clinic Ethics Review Committee
Address
Isobe Build. 2F, Samon-Cho13, Shinjyuku-ku, Tokyo
Tel
06-6882-1130
ethics_board@drc-web.co.jp
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
| 2020 | Year | 10 | Month | 22 | 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
44
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
| 2020 | Year | 08 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 21 | Day |
Last modified on
| 2021 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048122
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