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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028847
Receipt No. R000033012
Scientific Title The inhibitory effects on "UV-induced inflammation and pigmentation " by ingestion of test food in human.
Date of disclosure of the study information 2017/08/27
Last modified on 2018/06/05

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Basic information
Public title The inhibitory effects on "UV-induced inflammation and pigmentation " by ingestion of test food in human.
Acronym The inhibitory effects on "UV-induced inflammation and pigmentation " by ingestion of test food in human.
Scientific Title The inhibitory effects on "UV-induced inflammation and pigmentation " by ingestion of test food in human.
Scientific Title:Acronym 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
1st name
Middle name
Last name Dr. Sumio Kondo
Organization Medical Corporation Kenshokai
Division name Fukushima Healthcare Center
Zip code
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
1st name
Middle name
Last name Masafumi Takano
Organization DRC Co., Ltd.
Division name Product Testing Department
Zip code
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)

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
2017 Year 08 Month 27 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
2017 Year 08 Month 14 Day
Date of IRB
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

Other
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

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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