UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028847 |
|---|---|
| Receipt number | 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 11:03:13 |
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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
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
m.takano@drc-web.co.jp
Sponsor or person
Institute
Iwase Cosfa Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033012
