UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060051 |
|---|---|
| Receipt number | R000068427 |
| Scientific Title | Verification Study on the Effects of Test Food Intake on Skin - Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Trial - |
| Date of disclosure of the study information | 2025/12/11 |
| Last modified on | 2025/11/21 09:08:58 |
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Basic information
Public title
Verification Study on the Effects of Test Food Intake on Skin
- Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Trial -
Acronym
Verification Study on the Effects of Test Food Intake on Skin
Scientific Title
Verification Study on the Effects of Test Food Intake on Skin
- Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Trial -
Scientific Title:Acronym
Verification Study on the Effects of Test Food Intake on Skin
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 of consuming the test food on skin function and to confirm its safety.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stratum corneum moisture content
Key secondary outcomes
*Secondary Endpoints
1) Dermal water content
2) Transepidermal water loss
3) Skin viscoelasticity
4) Visual assessment by specialist physician
5) Perceived VAS questionnaire
*Exploratory Endpoints
1) Bowel movement diary
2) Analysis of fecal microbiota, metabolites, and pH
*Safety Evaluation Items
1) Physical examination (blood pressure/pulse, weight/body fat percentage/BMI)
2) Laboratory tests (hematological tests, blood biochemistry tests, urinalysis)
3) Daily activity log
4) Physician interviews and adverse event investigation
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 bottle in a day; 8 weeks)
Interventions/Control_2
Oral intake of the placebo food (1 bottle in a day; 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Men and women aged 35 years or older but under 65 years at the time of obtaining consent to participate in the trial.
2) Healthy individuals without chronic physical diseases, including skin diseases.
3) Individuals who perceive their skin as dry.
4) Individuals who have received sufficient explanation regarding the purpose and content of this trial, possess the capacity to consent, voluntarily volunteer to participate after fully understanding, and can provide written consent to participate in this trial.
5) Individuals who can attend the designated examination date and undergo the examination.
6) Individuals deemed suitable for participation in this trial by the principal investigator.
Key exclusion criteria
Individuals
1) currently suffering from any disease and undergoing drug treatment.
2) undergoing hormone replacement therapy.
3) with skin disease symptoms such as atopic dermatitis.
4) who have taken or applied medication for disease treatment within the past month.
5) with a history or current condition of serious disorders affecting the digestive organs, liver, kidneys, heart, lungs, blood, or mental health.
6) with a BMI of 30.0 kg/m2 or higher.
7) at risk of allergic reactions to components in the test food, or individuals at risk of severe allergic reactions to other foods or pharmaceuticals.
8) with a habit of excessive consumption of soy products such as tofu, natto, or soy milk.
9) with a current or recent (within 3 months) habit of regularly consuming FOSHU, functional foods, or health foods claiming benefits for skin, sleep, stress, or intestinal health.
10) whose average weekly alcohol consumption exceeds 40 g/day for men and 20 g/day for women, calculated as pure alcohol.
11) with smoking habits.
12) who may change their night work schedule or lifestyle habits during the trial period.
13) at risk of itching or other symptoms on evaluation sites during the trial due to seasonal allergies, and those who may use anti-allergy medications or nasal sprays.
14) unable to avoid intentional exposure to direct sunlight, such as sunbathing, during the trial period.
15) with a daily habit of using beauty devices such as facial beauty devices.
16) who have undergone cosmetic procedures or treatments on the evaluation site within the past 6 months, such as esthetic treatments or hyaluronic acid injections.
17) who are pregnant, breastfeeding, or who may become pregnant during the trial period.
18) currently participating in another human clinical trial, or individuals who have not completed 3 months since participating in another human clinical trial.
19) Other individuals deemed unsuitable for this trial by the principal investigator.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Gomi |
Organization
Yakult Honsha Co., Ltd.
Division name
Yakult Central Institute
Zip code
186-8650
Address
5-11 Izumi, Kunitachi-shi, Tokyo
TEL
042-577-8960
atsushi-gomi@yakult.co.jp
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
Yakult Honsha 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
| 2025 | Year | 12 | Month | 11 | 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
| 2025 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 02 | 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 | 12 | Month | 11 | Day |
Last modified on
| 2025 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068427
