UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063203 |
|---|---|
| Receipt number | R000072286 |
| Scientific Title | A Study on the Effects of Intake of the Test Food on Skin Conditions: A randomized, double-blind, placebo-controlled, parallel-group study |
| Date of disclosure of the study information | 2026/10/07 |
| Last modified on | 2026/10/07 13:47:12 |
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Basic information
Public title
A Study on the Effects of Intake of the Test Food on Skin Conditions
Acronym
A Study on the Effects of Intake of the Test Food on Skin Conditions
Scientific Title
A Study on the Effects of Intake of the Test Food on Skin Conditions: A randomized, double-blind, placebo-controlled, parallel-group study
Scientific Title:Acronym
A Study on the Effects of Intake of the Test Food on Skin Conditions: A randomized, double-blind, placebo-controlled, parallel-group study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of 8-week continuous intake of the test food on skin conditions in healthy adult men and women concerned about skin dryness through a randomized, double-blind, placebo-controlled, parallel-group study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Stratum corneum hydration
Key secondary outcomes
(1)Transepidermal water loss
(2)Skin viscoelasticity
(3)Dermal structure measurements
(4)Stratum corneum morphology analysis
(5)Facial skin image analysis
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
Continuous intake of the test food for 8 weeks
Interventions/Control_2
Continuous intake of the 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
| 35 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy Japanese men and women aged 35 to 64 years at the time of providing informed consent.
(2) Individuals concerned about skin dryness.
(3) Individuals who have received a sufficient explanation of the purpose and content of the study, have the capacity to provide consent, fully understand the content, and can provide personal consent via electronic informed consent.
Key exclusion criteria
(1) Persons with skin disease symptoms.
(2) Persons with wounds or inflammation on evaluation sites.
(3) Persons who consume foods that may affect the test results, or who are unable to restrict or discontinue their intake during study.
(4) Persons planning to change basic cosmetics on evaluation sites during study.
(5) Persons with cosmetic procedures on evaluation sites within 12 weeks prior to visit screening 1, and unable to refrain.
(6) Persons consuming health foods/FHC/FFC, or unable to stop.
(7) Persons with severe medical history or chronic disease under medical treatment/medication.
(8) Persons taking medications affecting test results.
(9) Persons with severe history of cerebrovascular, cardiac, hepatic, renal, hematologic, or endocrine diseases.
(10) Persons with severe history of GI surgery.
(11) Persons with risk of severe food allergies.
(12) Persons with significant test abnormalities at visit screening.
(13) Persons with risk of seasonal allergies using drugs during study.
(14) Persons with history of feeling unwell during blood collection.
(15) Blood donors: 200 mL within 4 weeks or component within 2 weeks; 400 mL within 16 weeks (women) or 12 weeks (men).
(16) Excessively sunburned persons, or unable to refrain from direct sunlight.
(17) Current smokers, or non-smokers who smoked within 3 months prior to study start.
(18) Habitual drinkers.
(19) Persons with extremely irregular sleep/dietary habits.
(20) Persons whose living, dietary, or exercise habits may change significantly.
(21) Women lactating, pregnant, possibly pregnant, or planning pregnancy.
(22) Participants in other trials currently, within 4 weeks prior to screening 1, or during study.
(23) Others deemed ineligible by the principal investigator.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Soma |
| Middle name | |
| Last name | Ode |
Organization
Macromill Carenet, Inc.
Division name
Clinical Research Solution Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan
TEL
03-6716-7108
umin_info@macromillcarenet.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Kimoto |
Organization
Macromill Carenet, Inc.
Division name
Clinical Research Solution Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan
TEL
03-6716-7108
Homepage URL
umin_info@macromillcarenet.jp
Sponsor or person
Institute
Macromill Carenet, Inc.
Institute
Department
Personal name
Funding Source
Organization
Yakult Central Institute
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
Institutional Review Board (IRB) of Tokyo Haneda Watanabe Clinic
Address
1-6-15 Haneda, Ota-ku, Tokyo, Japan
Tel
03-3741-0223
wnb.cto@gmail.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
| 2026 | Year | 10 | Month | 07 | 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
| 2026 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 02 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 07 | Day |
Last modified on
| 2026 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072286
