UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056762 |
|---|---|
| Receipt number | R000064863 |
| Scientific Title | Evaluation of the Effect of Test Food on skin conditions |
| Date of disclosure of the study information | 2025/08/31 |
| Last modified on | 2025/01/20 18:32:01 |
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Basic information
Public title
Evaluation of the Effect of Test Food on skin conditions
Acronym
Evaluation of the Effect of Test Food on skin conditions
Scientific Title
Evaluation of the Effect of Test Food on skin conditions
Scientific Title:Acronym
Evaluation of the Effect of Test Food on skin conditions
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine effects of a test food on skin conditions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Indexes for skin conditions (0, 8 weeks after ingestion)
Key secondary outcomes
Subject's diary
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
Oral ingestion of a test food for 8 weeks
Interventions/Control_2
Oral ingestion of a placebo food for 8 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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
1)Japanese females aged 30-59 years when informed consent.
2)Individuals who are healthy without chronic physical illness, including skin diseases.
3)Individuals who can detect ultraviolet erythema on the skin of the back.
4)Individuals who are type II or III of Fitzpatric skin type.
5)Individuals whose written informed consent has been obtained.
6)Individulals who can visit an inspection facility and be inspected in designated days.
7)Individuals judged appropriate for the study by the principal.
Key exclusion criteria
Individuals
1)using medical products.
2)who have or are being treated for skin disease symptoms.
3)with wounds or inflammation at the skin measurement points.
4)with a history of serious liver, kidney, heart, lung, or blood disease.
5)with a history of serious gastrointestinal disease.
6)with alcoholism or a mental illness.
7)who used or applied medications for disease treatment in the past 1 month.
8)who have an severe reaction to sunlight.
9)who have irregular menstrual cycles.
10)with food allergies.
11)with allergies or hypersensitivity to drugs or cosmetics.
12)with serious anemia.
13)who smoke.
14)who are or may be pregnant, or lactating.
15)whose lifestyle will change during the trial.
16)who are exposed to exceeded UV-light than in daily life.
17)who had a habit of ingesting foods for specified health uses or supplements containing ingredients of the test food in the past 3 months or will ingest them during the trial.
18)who had a habit of ingesting foods for specified health uses or supplements that improve skin condition in the past 3 months or will ingest them during the trial.
19)who had a habit of ingesting or applying anti-inflammatory drugs or drugs purporting to improve skin in the past 3 months.
20)who conducted hormone replacement therapy in the past 6 months.
21)who currently have undergone aesthetic salon, cosmetic treatment or cosmetic therapy under the supervision of a physician currently or within the past 6 months.
22)who plan to remove hair from the evaluation site during the trial.
23)who were hospitalized and received treatment in the past 6 months.
24)who participated in other clinical studies within one month of consent for this study or plan to participate in other clinical studies.
25)who judged inappropriate for this study by the principal investigator.
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Iemoto |
Organization
Morinaga & Co., Ltd.
Division name
Health Science and Research Center, R&D institute
Zip code
230-8504
Address
2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama
TEL
045-571-6140
n-iemoto-jb@morinaga.co.jp
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Saito |
Organization
Morinaga & Co., Ltd.
Division name
Health Science and Research Center, R&D institute
Zip code
230-8504
Address
2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa
TEL
045-571-6140
Homepage URL
e-saito-jd@morinaga.co.jp
Sponsor or person
Institute
Morinaga & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Morinaga & 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
Society of Glycative Stress Research
Address
3-3-13-6F 11,Nishishinjuku,Shinjuku-ku,Tokyo
Tel
03-6709-8842
rinri-glycativestress@antiaging-bank.com
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
| 2025 | Year | 08 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 12 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 20 | Day |
Last modified on
| 2025 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064863
