UMIN-CTR Clinical Trial

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
Email	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
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	Kagome CO., LTD.
Address	Nihonbashi-hamacho F-Tower, 3-21-1 Nihonbashi-hamacho, Chuo-ku, Tokyo 103-8461, Japan
Tel	03-5623-8501
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040326