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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035471
Receipt No. 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 2018/12/28

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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
Middle name
Last name Koichi Aizawa
Organization Kagome CO.,LTD.
Division name Innovation Division
Zip code
Address 17 Nishitomiyama, Nasushiobarashi, Tochigi
TEL 0287-36-2935
Email Koichi_Aizawa@kagome.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Miwa Kaneko
Organization SOUKEN Co., Ltd.
Division name Office
Zip code
Address 3F Daiwa A Hamamatsucho Building, 1-9-10 Hamamatsucho, Minato-ku, Tokyo
TEL 03-5408-1555
Homepage URL
Email m_kaneko@mail.souken-r.com

Sponsor
Institute Kagome CO., LTD.
Institute
Department

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
Address
Tel
Email

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
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 Preinitiation
Date of protocol fixation
2018 Year 12 Month 14 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 09 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
2019 Year 01 Month 07 Day
Last modified on
2018 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040326

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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