UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056580 |
|---|---|
| Receipt number | R000064440 |
| Scientific Title | Effects of a test food on skin conditions |
| Date of disclosure of the study information | 2025/09/25 |
| Last modified on | 2025/09/25 13:34:18 |
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Basic information
Public title
Effects of a test food on skin conditions
Acronym
Effects of a test food on skin conditions
Scientific Title
Effects of a test food on skin conditions
Scientific Title:Acronym
Effects of a test food on skin conditions
Region
| Japan |
Condition
Condition
N/A(healthy adults)
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
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 women aged 30-59 years.
2)Individuals who are healthy without chronic physical illness, including skin diseases.
3)Individuals who are concerned about skin dryness.
4)Individuals whose written informed consent has been obtained.
5)Individulals who can visit an inspection facility and be inspected in designated days.
6)Individuals judged appropriate for the study by the principal.
Key exclusion criteria
1) Individuals using medical products.
2) Individuals who have or are being treated for skin disease symptoms.
3) Individuals with wounds or inflammation at the skin measurement points.
4) Individuals with a history of serious liver, kidney, heart, lung, or blood disease.
5) Individuals with a history of serious gastrointestinal disease.
6) Individuals with alcoholism or a mental illness.
7) Individuals who used or applied medications for disease treatment in the past 1 month.
8) Individuals who may not control seasonal allergy symptoms with regular medications during the trial.
9) Individuals with food allergies.
10) Individuals with serious anemia.
11) Individuals who smoke.
12) Individuals who are or may be pregnant, or lactating.
13) Individuals whose lifestyle will change during the trial.
14) Individuals who will get sunburned during the trial.
15) Individuals 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.
16) Individuals 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.
17) Individuals who had a habit of ingesting or applying pharmaceuticals, quasi-drugs, or cosmetics likely to affect the trial in the past 3 months.
18) Individuals who conducted hormone replacement therapy in the past 6 months.
19) Individuals who received special facial care at external institutions currently or within the past 6 months.
20) Individuals who received cosmetic medicine in the past 6 months.
21) Individuals who were hospitalized and received treatment in the past 6 months.
22) Individuals who participated in other clinical studies within one month of consent for this study or plan to participate in other clinical studies.
23) Individuals judged inappropriate for the study by the principal.
Target sample size
86
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 | Yosuke |
| Middle name | |
| Last name | Seto |
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
y-seto-bd@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
General Incorporated Association Crinical Research Review Center
Address
2972-8-603 Ishikawamachi Hachioji-shi, Tokyo, 192-0032, JAPAN
Tel
090-3547-6398
crrctakashima@kpd.biglobe.ne.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 25 | 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
86
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 | 11 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 03 | 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 | 12 | Month | 26 | Day |
Last modified on
| 2025 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064440
