UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035471 |
|---|---|
| Receipt number | R000040326 |
| Scientific Title | Clinical evaluation of dietary intake of carrot juice in preventing ultraviolet-induced (UV) erythema formation |
| Date of disclosure of the study information | 2019/01/08 |
| Last modified on | 2019/09/04 11:06:20 |
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Basic information
Public title
Clinical evaluation of dietary intake of carrot juice in preventing ultraviolet-induced (UV) erythema formation
Acronym
Preventive effect of carrot juice on UV-induced erythema
Scientific Title
Clinical evaluation of dietary intake of carrot juice in preventing ultraviolet-induced (UV) erythema formation
Scientific Title:Acronym
Preventive effect of carrot juice on UV-induced erythema
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to demonstrate the efficacy of dietary intake of carrot juice in preventing UV-induced erythema in healthy Japanese subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin color (a* and erythema index) on the UV -irradiated region and minimum erythema dose (MED) at 0, 8, and 12 weeks after intake of test foods
Key secondary outcomes
Skin color (L*), Melanin index, Stratum corneum hydration, Transepidermal water loss, Index of skin regeneration
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Carrot juice (200 mL/day for 12 weeks)
Interventions/Control_2
Placebo (200 mL/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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Japanese men whose age at the time of consent acquisition date is from 20 years old to under 59 years old
2) Subjects whose skin will sunburn (form erythema) easily by UV irradiation and does not develop or cause less a tan after irradiation
3) Subjects who has fair skin or not dark skin
4) Subjects who can avoid to have alcohol during from the day before test day to test end
5) Subjects who can agree to remain sunburn marks in test areas about half-year
6) Subjects who agree to trial purpose and contents, and give written informed consent
Key exclusion criteria
1) Subjects who are hospitalized for their disease treatment or who takes medicine
2) Subjects who habitually takes medicine such as anti-histamine drugs, anti-inflammatory drugs, and sedatives
3) Subjects who have risk of skin allergies and subjects with a diagnosis of photo sensitive disorder
4) Subjects who are hospitalized in dermatology department
5) Subjects who have risk of pollen allergies and using medicine during the study period
6) Subjects who have risk of allergies to carrot juice
7) Subjects who dislike carrot juice or vegetable juice
8) Subjects who have blister after sunburn
9) Subjects whose upper arms are extremely skinny
10) Subjects with apparent pigmentation, inflammation, and other diseases in the test area
11) Subjects who cannot avoid to be exposed to exceeded UV-light than in daily life by activities including long hours of outwork, sports, and leisure activities
12) Subjects who have a plan to go abroad, sea bathing, etc. during the study period
13) Subjects who take special care of facial skin
14) Subjects who are feeding vegetable-based diet
15) Subjects who habitually consume carrot juice, vegetable juice, or beta-carotene-rich foods
16) Subjects who habitually consume carotenoid-rich supplements
17) Subjects who habitually use pharmaceuticals, quasi-drugs, and supplements effective in the treatment of UV-induced skin pigmentation and chloasma, such as L-cysteine-containing drugs, vitamin-C-containing drugs, and tranexamic acid-containing drugs
18) Subjects who habitually use pharmaceuticals, quasi-drugs, supplements, and health claim foods effective in skin moisture retention
19) Subjects with smoking habit
20) Subjects who habitually consume higher amount of alcohol
21) Subjects who have participated in other human studies within the past 2 months, or who are participating
22) Subjects who had artificial UV-treatment within the past 2 months
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Aizawa |
Organization
Kagome CO.,LTD.
Division name
Innovation Division
Zip code
329-2762
Address
17 Nishitomiyama, Nasushiobarashi, Tochigi
TEL
0287-36-2935
Koichi_Aizawa@kagome.co.jp
Public contact
Name of contact person
| 1st name | Miwa |
| Middle name | |
| Last name | Kaneko |
Organization
SOUKEN Co., Ltd.
Division name
Office
Zip code
105-0012
Address
3F Daiwa A Hamamatsucho Building, 1-9-10 Hamamatsucho, Minato-ku, Tokyo
TEL
03-5408-1555
Homepage URL
m_kaneko@mail.souken-r.com
Sponsor or person
Institute
Kagome CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
Kagome CO., LTD.
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
Kagome CO., LTD.
Address
Nihonbashi-hamacho F-Tower, 3-21-1 Nihonbashi-hamacho, Chuo-ku, Tokyo 103-8461, Japan
Tel
03-5623-8501
Takuji_Hayakawa@kagome.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
| 2019 | Year | 01 | Month | 08 | 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
68
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
| 2018 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 07 | Day |
Last modified on
| 2019 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040326
