UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063464 |
|---|---|
| Receipt number | R000072176 |
| Scientific Title | A Study on the Effects of Consuming a Test Food on Skin Function -- A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Trial -- |
| Date of disclosure of the study information | 2026/10/29 |
| Last modified on | 2026/09/25 17:23:26 |
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Basic information
Public title
A Study on the Effects of Consuming a Test Food on Skin Function
-- A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Trial --
Acronym
A Study on the Effects of Consuming a Test Food on Skin Function
Scientific Title
A Study on the Effects of Consuming a Test Food on Skin Function
-- A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Trial --
Scientific Title:Acronym
A Study on the Effects of Consuming a Test Food on Skin Function
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effects on skin function and the safety of consuming the test food for 12 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin viscoelasticity
Key secondary outcomes
* Secondary Endpoints
1) Skin hydration
2) Trans-epidermal water loss
3) VISIA image analysis
4) Skin wrinkle replica analysis
5) Collagen score
6) Visual assessment by a specialist
7) Subjective VAS questionnaire
* Safety Assessment Items
1) Weight / Body Fat Percentage / BMI
2) Blood Pressure / Pulse
3) Hematological Tests
4) Blood Biochemistry Tests
5) Urinalysis
6) Physician Interview / Presence or Absence of Side Effects / Adverse Event Assessment
7) Daily Activity Log
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 intake of the test food (1 stick in a day; 12 weeks).
Interventions/Control_2
Oral intake of the placebo food (1 stick in a day; 12 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
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
1) Healthy women aged 35 or older but under 65 at the time of obtaining consent to participate in the study.
2) Healthy individuals with no chronic physical conditions, including skin conditions.
3) Individuals concerned about their skin's elasticity and firmness.
4) Individuals who have been fully informed of the purpose and content of the study, have the capacity to consent, understand the study well, voluntarily volunteer to participate, and are able to consent to participation in the study in writing.
5) Individuals who can come to the designated venue for this study and be inspected.
6) Individuals deemed suitable for participation in the study by the principal investigator.
Key exclusion criteria
Individuals
1) currently suffering from any medical condition and undergoing drug therapy.
2) undergoing hormone replacement therapy.
3) with symptoms of skin conditions such as atopic dermatitis.
4) who, within the past month, have taken or applied medications for the purpose of treating a medical condition.
5) with a history of serious past or current medical conditions affecting the liver, kidneys, heart, lungs, blood, digestive system, or mental health.
6) whose BMI is over 30 kg/m2.
7) at risk of allergic reactions to the test food ingredients, other foods, or drugs.
8) who currently or within the past 3 months regularly used health foods claiming skin benefits or containing ingredients similar to the test food.
9) whose average weekly alcohol consumption, calculated as pure alcohol, exceeds 20 g/day.
10) Smokers.
11) Night shift workers.
12) likely to change their lifestyle or have significantly different routines, such as overseas travel, during the study.
13) who may develop seasonal allergies affecting the test site or use antiallergic drugs or nasal sprays during the study.
14) unable to avoid intentional sun exposure during the study.
15) who are extremely negligent in their skin care.
16) with a history of cosmetic procedures or treatments on the evaluation area.
17) with wounds or inflammation on the evaluation area.
18) with severe premenstrual or menstrual skin worsening that significantly affects daily life.
19) who are pregnant, breastfeeding, or who may become pregnant during the trial period.
20) currently in another clinical trial or within 3 months after participation.
21) judged inappropriate for the study by the principal.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Miyoshi |
Organization
MEGMILK SNOW BRAND Co., Ltd.
Division name
Milk Science Research Institute
Zip code
350-1165
Address
1-1-2, Minamidai, Kawagoe-shi, Saitama, 350-1165, Japan
TEL
+81-49-242-8064
m-miyoshi@meg-snow.com
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
MEGMILK SNOW BRAND 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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 19 | 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 | 29 | Day |
Last modified on
| 2026 | 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=R000072176
