UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022059 |
|---|---|
| Receipt number | R000025426 |
| Scientific Title | Clinical effect of long-time intake of beauty foods in preventing ultraviolet(UV)-induced erythema formation in Japanese subjects -Placebo controlled double-blind trial- |
| Date of disclosure of the study information | 2016/04/25 |
| Last modified on | 2016/10/12 10:57:39 |
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Basic information
Public title
Clinical effect of long-time intake of beauty foods in preventing ultraviolet(UV)-induced erythema formation in Japanese subjects -Placebo controlled double-blind trial-
Acronym
Clinical effect of long-time intake of beauty foods in preventing ultraviolet(UV)-induced erythema formation in Japanese subjects
Scientific Title
Clinical effect of long-time intake of beauty foods in preventing ultraviolet(UV)-induced erythema formation in Japanese subjects -Placebo controlled double-blind trial-
Scientific Title:Acronym
Clinical effect of long-time intake of beauty foods in preventing ultraviolet(UV)-induced erythema formation in Japanese subjects
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirmation of the prevention of UV-induced erythema formation after long-time intake of beauty foods in healthy subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)MED(minimal erythema dose) at 0, 5 weeks after the intake
2)Degree of erythema 1 day after 1.5 MED UV irradiation at 0, 5 weeks after the intake
Key secondary outcomes
Degree of melanin formation induced by 1.5 MED UV irradiation at 0, 5 weeks after the intake
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
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Beauty foods (once a day for 6 weeks)
Interventions/Control_2
Placebo (once a day for 6 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
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
1)Subjects giving written informed consent
2) Healthy women whose age 30 to 49 years old, who were conscious of skin dryness.
3)Subjects whose skin will sunburn (from erythema) easily and develop a tan by UV irradiation
Key exclusion criteria
1)Subjects with history of photo sensitivity
2)Subjects who have chronic diseases and administer treatments and medications
3)Subjects with apparent pigmentation, inflammation, and other diseases in the test area
4)Subjects who have milk or gelatin allergy
5)Subjects who have lactose intolerance
6)Subjects who habitually consume yogurt or fermented milk drink more than 2 times a week
7)Subjects who drink more than 200 mL of milk daily
8)Subjects who use pharmaceuticals, quasi-drugs, dietary supplement effective in the treatment of UV-induced skin pigmentation, rough skin, and arthralgia
9)Subjects who use anti-inflammatory drugs more than once a month
10)Subjects who have excessive sunburn in 2 months
11)Subjects who participated in other clinical trials within a month or plan to participate other clinical trials during this study period
12)Subjects who is in pregnancy, or plan to get pregnant during this study period
13)Subjects who is breast-feeding
14)Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taketo Yamaji |
Organization
Meiji Co., Ltd.
Division name
Food Science Research Laboratories, R&D Division
Zip code
Address
540 Naruda, Odawara, Kanagawa, 250-0862 Japan
TEL
0465-37-3652
taketo.yamaji@meiji.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Fukasawa |
Organization
Meiji Co., Ltd.
Division name
Food Science Research Laboratories, R&D Division
Zip code
Address
540 Naruda, Odawara, Kanagawa, 250-0862 Japan
TEL
0465-37-3652
Homepage URL
tomoyuki.fukasawa@meiji.com
Sponsor or person
Institute
Food Science Research Laboratories, R&D Division, Meiji Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Food Science Research Laboratories, R&D Division, Meiji 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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 25 | 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
| 2016 | Year | 04 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
| 2016 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 08 | Month | 03 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 25 | Day |
Last modified on
| 2016 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025426
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| Registered date | File name |
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