UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042757 |
|---|---|
| Receipt number | R000048735 |
| Scientific Title | Evaluation of the anti-glycation effect and damage reduction on the skin of ultraviolet rays by the test food: A randomized, double-blind, placebo-controlled, parallel-group, trial. |
| Date of disclosure of the study information | 2020/12/16 |
| Last modified on | 2021/06/16 07:56:18 |
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Basic information
Public title
Evaluation of the anti-glycation effect and damage reduction on the skin of ultraviolet rays by the test food.
Acronym
Evaluation of the anti-glycation effect and damage reduction on the skin of ultraviolet rays by the test food.
Scientific Title
Evaluation of the anti-glycation effect and damage reduction on the skin of ultraviolet rays by the test food: A randomized, double-blind, placebo-controlled, parallel-group, trial.
Scientific Title:Acronym
Evaluation of the anti-glycation effect and damage reduction on the skin of ultraviolet rays by the test food.
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of ingestion of the test food on the skin damage and glycation stress caused by UV rays.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
MED (Minimal Erythema Dose) judgment
Key secondary outcomes
1. Skin tone
2. Melanin amount and redness
3. Transepidermal water loss
4. Skin moisture content
5. Plasma Pentosidine
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Duration: 8 weeks
Test food: Test food
Administration: Take 1 tablet, three times a day.
The daily dose of 3 tablets should be taken within the same day. If you miss a dose, take it when you notice it and do not carry it over to the next day.
Interventions/Control_2
Duration: 8 weeks
Test food: Test food
Administration: Take 1 tablet, three times a day.
The daily dose 3 tablets should be taken within the same day. If you miss a dose, take it when you notice it and do not carry it over to the next day.
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
1) Subjects who are judged by a doctor to be eligible.
2) Subjects who can confirm 1MED in any of the 6 irradiation fields by MED (Minimal Erythema Dose) judgment. However, if the number of people who meet the conditions exceeds the number to be selected, those who can confirm 1 MED with a smaller irradiation energy will be selected.
Key exclusion criteria
1) Subjects who treatment of illness.
2) Subjects who take medication.(antihistamines, anti-inflammatory agents, analgesics) on a regular basis.
3) Subjects who may show symptoms of skin allergies and skin hypersensitivity.
4) Subjects who are currently visit dermatologist.
5) Subjects who may have blisters due to sunburn.
6) Subjects with extremely thin upper arms.
7) Subjects with predisposition or scars on the medial upper arm of both arms that may affect the results of the test (diseases such as atopic dermatitis and urticarial, inflammation, eczema, trauma, acne, pimples, warts, stain, etc).
8) Subjects who cannot avoid sunburn due to long hours of outdoor work or sports from screening to the end of the test.
9) Subjects who plan to travel abroad or swim in the sea from screening to the end of the test.
10) Smoker.
11) Subjects who have been exposed to artificial ultraviolet rays within the past two months.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Mahamadou |
| Middle name | |
| Last name | Tandia |
Organization
Toyo Sugar Refining Co., Ltd.
Division name
Research & Development Department
Zip code
103-0016
Address
18-20, Nihombashi-Koamicho, Chuo-ku, Tokyo 103-0046, Japan
TEL
03-3668-7894
mtandia@toyosugar.co.jp
Public contact
Name of contact person
| 1st name | Yushi |
| Middle name | |
| Last name | Hashizume |
Organization
Toyo Sugar Refining Co., Ltd.
Division name
Research & Development Department
Zip code
290-0046
Address
1-6-41, Iwasaki-Nishi Ichihara City, Chiba
TEL
0436-21-8127
Homepage URL
hashizume-y@toyosugar.co.jp
Sponsor or person
Institute
SOUKEN Co., Ltd
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Shiba Palace Clinic
Address
DaiwaA Hamamatsucho Building 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, Japan
Tel
03-5408-1599
jimukyoku@mail.souken-r.com
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 | 12 | Month | 16 | 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
| 2020 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 28 | 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 | 12 | Month | 15 | Day |
Last modified on
| 2021 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048735
