UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018903 |
|---|---|
| Receipt number | R000021876 |
| Scientific Title | Clinical evaluation of dietary intake of tomato juice in preventing ultraviolet-induced (UV) erythema formation in Japanese subjects |
| Date of disclosure of the study information | 2015/09/05 |
| Last modified on | 2016/03/04 03:56:11 |
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Basic information
Public title
Clinical evaluation of dietary intake of tomato juice in preventing ultraviolet-induced (UV) erythema formation in Japanese subjects
Acronym
Preventive effect of tomato juice on UV-induced erythema in Japanese
Scientific Title
Clinical evaluation of dietary intake of tomato juice in preventing ultraviolet-induced (UV) erythema formation in Japanese subjects
Scientific Title:Acronym
Preventive effect of tomato juice on UV-induced erythema in Japanese
Region
| Japan |
Condition
Condition
UV-induced erythema
Classification by specialty
| Dermatology | Aesthetic surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to demonstrate the efficacy of dietary intake of tomato juice in preventing UV-induced erythema in Japanese subjects, and confirm the contribution of lycopene to the effect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Erythema formation induced by UV radiation at 0, 8, and 12 weeks after beginning the study
Key secondary outcomes
Increased level of malondialdehyde in stratum corneum, increased pigmentation, and changes in serum carotenoids (lycopene, beta-carotene, etc. and vitamin E)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
tomato juice (once a day for 12 weeks)
Interventions/Control_2
Lycopene-rich tomato juice (once a day for 12 weeks)
Interventions/Control_3
Placebo (once a day for 12 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
| 25 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Healthy Japanese Subjects
2) Subjects whose skin will sunburn (form erythema) easily and develop a tan by UV irradiation
Key exclusion criteria
1) Subjects with apparent pigmentation, inflammation, and other diseases in the inside of both upper arms
2) Subjects with history of photo sensitivity
3) Subjects who habitually consume tomato juice or lycopene-rich foods
4) Subjects who use pharmaceuticals and quasi-drugs effective in the treatment of UV-induced skin pigmentation and chloasma
5) Female subjects who is breast-feeding or in pregnancy, or plan to get pregnant during this study period
6) Subjects with risk of allergy regarding to this study
7) Subjects with smoking habit
8) Subjects who habitually consume higher amount of alcohol (> avg 60 g alcohol/day)
9) Subjects who participated in other clinical trials within 2 months.
10) Subjects who are judged unsuitable for this study by principal investigator and doctors.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Suganuma |
Organization
Kagome Co., Ltd.
Division name
Research & Development Division
Zip code
Address
17 Nishitomiyama, Nasushiobara, Tochigi 3292762, Japan
TEL
0287-36-2935
Hiroyuki_Suganuma@kagome.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunori Takashima |
Organization
Inforward, Inc
Division name
Ebisu Skin Research Center
Zip code
Address
1-11-2 Ebisu, Shibuya, Tokyo 1500013, Japan
TEL
03-5447-6411
Homepage URL
takashima@inforward.co.jp
Sponsor or person
Institute
Kagome 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
Inforward, Inc
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
株式会社インフォワード恵比寿スキンリサーチセンター（東京都）
Ebisu Skin Research Center, Inforward, Inc (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 05 | 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
| 2015 | Year | 08 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | 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
| 2015 | Year | 09 | Month | 03 | Day |
Last modified on
| 2016 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021876
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
