UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060732 |
|---|---|
| Receipt number | R000069359 |
| Scientific Title | A study to examine the effects of test food intake on skin function |
| Date of disclosure of the study information | 2026/02/23 |
| Last modified on | 2026/02/22 17:13:04 |
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Basic information
Public title
A study to examine the effects of test food intake on skin function
Acronym
A study to examine the effects of test food intake on skin function
Scientific Title
A study to examine the effects of test food intake on skin function
Scientific Title:Acronym
A study to examine the effects of test food intake on skin function
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this trial is to conduct human testing and evaluate the effects on the skin of continuous consumption of 'To-jun', a food product developed by Rosavista Co., Ltd. containing mulberry leaf extract, tobi fruit peel extract, and acetic acid bacteria ferment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in SAF values before and after continued consumption of the test food
Key secondary outcomes
Questionnaire Survey (Anti-Ageing QOL Common Questionnaire and Skin Type Questionnaire)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Consume the test food.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
1) Women aged 20 years or older but under 70 years at the time of obtaining consent to participate in the trial
2) Healthy individuals without chronic physical illnesses
3) Individuals who have received sufficient explanation regarding the purpose and content of this trial, possess the capacity to consent, have fully understood the information, voluntarily wish to participate, and can provide written consent to participate in this trial
4) Individuals who can attend the centre on the designated examination date and undergo the examination
5) Individuals deemed suitable for participation in this trial by the principal investigator
Key exclusion criteria
1) Individuals currently suffering from any disease and undergoing drug treatment
2) Individuals with a history or current condition of impaired glucose tolerance, mental illness, sleep disorders, hypertension, diabetes, hyperlipidaemia, or other serious diseases
3) Individuals with a history of regular medication use within the past month for disease treatment (excluding occasional use for headaches, menstrual pain, colds, etc.)
4) Individuals with a history or current condition of severe impairment of the liver, kidneys, heart, lungs, blood, etc.
5) Individuals with concomitant diseases or a history of diseases of the digestive organs (excluding a history of appendicitis)
6) Individuals with a BMI of 30 kg/m2 or above
7) Individuals at risk of developing allergic reactions to the test food, or those at risk of severe allergic reactions to other foods or medicines
8) Individuals who have donated blood exceeding 200 mL within the past month, or 400 mL within the past three months
9) Individuals with severe anaemia
10) Individuals who are pregnant, breastfeeding, or who may be pregnant
11) Individuals who currently have, or have had within the past three months, a habit of continuously consuming functional foods or health foods marketed for skin quality improvement, or who plan to consume such products during the trial period (consumption for general health maintenance is permissible)
12) Individuals with photosensitivity
13) Other individuals deemed unsuitable for this trial by the principal investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Karen |
| Middle name | |
| Last name | Tagashira |
Organization
rosavista Co., Ltd.
Division name
Representative Director
Zip code
150-0013
Address
M Residence Ebisu 203 2-13-17 Ebisu, Shibuya-ku, Tokyo
TEL
03-3572-7550
tagashira.k@rosavista.co.jp
Public contact
Name of contact person
| 1st name | Karen |
| Middle name | |
| Last name | Tagashira |
Organization
rosavista Co., Ltd.
Division name
Representative Director
Zip code
150-0013
Address
M Residence Ebisu 203 2-13-17 Ebisu, Shibuya-ku, Tokyo
TEL
03-3572-7550
Homepage URL
tagashira.k@rosavista.co.jp
Sponsor or person
Institute
rosavista Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Rosavista 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
6F,Nishishinjuku Mizuma Bldg,3-3-13 Nishishinjuku,Shinjuku-ku,Tokyo
Tel
03-6868-4364
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
| 2026 | Year | 02 | Month | 23 | 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 | 01 | Month | 29 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 31 | 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 | 02 | Month | 22 | Day |
Last modified on
| 2026 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069359
