UMIN-CTR Clinical Trial

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
Email	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
Email	hashizume-y@toyosugar.co.jp

Sponsor
Institute	SOUKEN Co., Ltd
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048735