UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The inhibitory effects on "UV-induced inflammation and pigmentation " by ingestion of test food in human.
Title of the study (Brief title)	The inhibitory effects on "UV-induced inflammation and pigmentation " by ingestion of test food in human.
Region	Japan

Condition
Condition	Healthy people
Classification by specialty	Dermatology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether skin inflammatory reactions induced by ultraviolet rays are reduced by consecutive ingestion of foods which contains lactic acid bacteria stored in Nissin Foods
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) MED (minimal erythemal dose)
Key secondary outcomes	1) Erythemal and pigmentation in the MED site and nearby areas of the MED site 2) Erythemal and pigmentation in the 1.5 MED site and nearby areas of the MED site 3) Antioxidant effect: Catalase activity in the stratum corneum of the exposed area 4) Questionnaire for use feedbacks 5) Adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of the lactic acid bacteria stored in Nissin Foods A food 2 capsules per day for 9 weeks.
Interventions/Control_2	Ingestion of the lactic acid bacteria stored in Nissin Foods B food 2 capsules per day for 9 weeks.
Interventions/Control_3	Ingestion of the placebo food 2 capsules per day for 9 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	30 years-old <=
Age-upper limit	49 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Japanese adults aged from 30 to 49 years old at the time of informed consent was provided 2) Male and female 3) Type II or III of Fitzpatric Skin Type 4) Voluntary test participants who provided written informed consent
Key exclusion criteria	1)Persons who are photosensitivity 2)Persons who take medications for light sensitivity of the skin 3)Persons who are prone to allergies for foods or have lactose intolerance 4)Persons who are a regular patient at the hospital for treatment in dermatological issues 5)Persons who have factors and symptoms of skin diseases on the skin of the evaluation site (diseases such as atopic dermatitis and urticaria, inflammation, eczema, etc., extreme sunburn history on the back), which may affect the test results 6)Persons who have subjective symptoms of severe anemia 7)Persons who are receiving treatment at a medical institution or those who judged to be in the relevant condition requires treatment 8)Persons who have the following medical history : severe diseases (such as sugar metabolism, lipid metabolism, liver function, renal function, heart, circulatory organs, respiratory organs, endocrine system, the nervous system), psychiatric diseases, or alcohol and drug dependence 9)Persons who have received skincare and spa treatment to the evaluation site within the past 4 weeks 10)Persons who have been exposed to ultraviolet rays beyond their daily life within the past 2 months 11)Persons who have irregular or disturbed life style such as night shifts 12)Persons who have participated in other clinical studies within the past 4 weeks 13)Persons who are pregnant or lactating, or who hope to become pregnant during the test 14)Persons who have difficulties with filling the subject diary 15)Persons who are identified inappropriate for the test by the investigator 16)Persons who smoke 17)Persons who continuously ingested health foods, supplements, nutrition-enhanced foods (especially, yoghurt, lactic acid bacteria preparations, vitamins, polyphenols, etc) within the past 4 weeks 18)Persons whose menstrual cycle is disturbed within the past 2 months 19)Persons who consume 40 g or more per day for males and 20 g or more per day for females by pure alcohol conversion
Target sample size	90

Research contact person
Name of lead principal investigator	Dr. Sumio Kondo
Organization	Medical Corporation Kenshokai
Division name	Fukushima Healthcare Center
Address	2-12-13, Tamagawa Fukushima-ku, Osaka, Japan
TEL	06-6882-1130
Email	s.kondo@drc-web.co.jp

Public contact
Name of contact person	Masafumi Takano
Organization	DRC Co., Ltd.
Division name	Product Testing Department
Address	No.9 Tabuchi Bldg. 3F, 2-10-31, Higashi-Temma, Kita-ku, Osaka
TEL	06-6882-1130
Homepage URL
Email	m.takano@drc-web.co.jp

Sponsor
Institute	Iwase Cosfa Co., Ltd.
Institute
Department

Funding Source
Organization	Nissin Foods Holdings Co., Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 08 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 14 Day
Anticipated trial start date	2017 Year 08 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 08 Month 26 Day
Last modified on	2018 Year 06 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033012