UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055104 |
|---|---|
| Receipt number | R000062950 |
| Scientific Title | Clinical evaluation of dietary intake of test food in preventing ultraviolet-induced (UV) erythema formation |
| Date of disclosure of the study information | 2024/07/29 |
| Last modified on | 2025/08/13 15:26:37 |
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Basic information
Public title
Clinical evaluation of dietary intake of test food in preventing ultraviolet-induced (UV) erythema formation
Acronym
Preventive effect of test food on UV-induced erythema
Scientific Title
Clinical evaluation of dietary intake of test food in preventing ultraviolet-induced (UV) erythema formation
Scientific Title:Acronym
Clinical evaluation of dietary intake of test food in preventing ultraviolet-induced (UV) erythema formation
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 test food 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
Absolute value of Minimal erythema dose (MED) after ingestion of test food
Key secondary outcomes
Amount of change in MED and absolute value and change in skin color (a* and L*), stratum corneum hydration and concentration of serum plant-derived component after ingestion of test food
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test food (190 g/day for 13 weeks)
Interventions/Control_2
Placebo(190 g/day for 13 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 and Female
Key inclusion criteria
(1) Healthy adults between the ages of 20 and less than 60 years old
(2) Subjects whose Fitzpatrick skin phototype is type II or type III
(3) Subjects who be able to visit the test site on all test days
(4) Subjects who have been fully informed of the purpose and content of the research, have the capacity to consent, and have voluntarily volunteered to participate in the research based on a good understanding of the purpose and content of the research, and have agreed to participate in the research in writing
(5) Subjects whose dorsal skin can be determined to have UV erythema
(6) Subjects who were judged to have MED in the third, fourth, fifth of the six levels of UV radiation at the time of MED judgment before ingestion of the test product
Key exclusion criteria
(1) Subjects who are undergoing or requires medical treatment
(2) Subjects taking anti-inflammatory medicine at least once a month
(3) Subjects who have a medical history for severe disease or abnormality
(4) Subjects who have a medical history of alcoholism or drug addiction
(5) Subjects with a history or current history of atopic dermatitis
(6) Subjects who drink excessive amounts of alcohol on a daily basis
(7) Smokers
(8) Subjects with photosensitivity disorder
(9) Subjects who have symptoms of skin diseases on the evaluation site
(10) Subjects who have had allergic reactions to drugs or foods
(11) Subjects who take medicine that affect light sensitivity of skin
(12) Subjects who have difficulty with taste of test food
(13) Subjects who regularly take foods containing a large amount of plant-derived component
(14) Subjects who take functional foods containing vitamin C
(15) Subjects who take functional foods which has same or similar effect with active ingredient of test food
(16) Subjects who use pharmaceuticals effective in the treatment of skin pigmentation and chloasma
(17) Subjects who use basic skin care products containing vitamin C
(18) Subjects who use skin care products, cosmetics, quasi-drugs that advocate efficacy
related to the efficacy examined in this study
(19) Subjects who received or plan to receive cosmetic treatment to the evaluated site
(20) Subjects who have undergone any special skin care treatment within the past 4 weeks
(21) Subjects who have changed and/or started using functional foods and/or sunscreen on the target area within 4 weeks
(22) Subjects who exposed to ultraviolet rays beyond daily life
(23) Subjects who plan to travel abroad or domestic trip of more than one week
(24) Shiftworkers
(25) Subjects who are pregnant or breastfeeding
(26) Subjects who were involved in another clinical studies within 4 weeks prior to the trial
(27) Subjects who are judged to be inappropriate for the study by the principal investigator
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Takahashi |
Organization
KAGOME CO., LTD.
Division name
Diet & Well-being Research Institute
Zip code
329-2762
Address
17 Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
0287-36-2935
Shingo_Takahashi@kagome.co.jp
Public contact
Name of contact person
| 1st name | Yuhma |
| Middle name | |
| Last name | Yoshida |
Organization
DRC CC., LTD.
Division name
Product Testing Department
Zip code
530-0044
Address
Tabuchi Bldg. No.9 3F, Higashi-Temma, Kita-ku, Osaka 530-0044, Japan
TEL
06-6882-1130
Homepage URL
yoshida@drc-web.co.jp
Sponsor or person
Institute
KAGOME CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
NONE
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
Brain Care Clinic Ethics Review Committee
Address
Shiratori Bldg. 2F, 2-1-2 Shinjyuku, Shinjyuku-ku, Tokyo
Tel
06-6882-1130
ethics_board@drc-web.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
DRC株式会社（大阪府）/ DRC CO., LTD.(Osaka)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 29 | 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
| 2024 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 29 | Day |
Last modified on
| 2025 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062950
