UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057214 |
|---|---|
| Receipt number | R000065388 |
| Scientific Title | Study on the effect of test food intake on skin function |
| Date of disclosure of the study information | 2025/03/07 |
| Last modified on | 2025/08/29 15:20:21 |
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Basic information
Public title
Study on the effect of test food intake on skin function
Acronym
Study on the effect of test food intake on skin function
Scientific Title
Study on the effect of test food intake on skin function
Scientific Title:Acronym
Study on the effect of test food intake on skin function
Region
| Japan |
Condition
Condition
N/A (healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to examine the effects on skin function and to confirm the safety of a beverage containing mangosteen extract.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Transepidermal water loss,Moisture of the skin surface,Skin viscoelasticity,Skin color quantification,Observation for skin condition by dermatologists
Key secondary outcomes
Fluorescent AGEs (AF)
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
Intake of one bottle (25 mL) of the test food per day for 8 weeks.
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
| 35 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
[1]Female aged between 35 and 60 at the time of informed consent
[2]Individuals who are healthy and have no chronic physical disease including skin disease.
[3]Individuals who are aware of skin deterioration such as elasticity and sagging
[4]Individuals whose written informed consent has been obtained.
[5]Individuals who can come to the designated venue for this study and be inspected.
[6]Individuals judged appropriate for this study by a responsible doctor.
Key exclusion criteria
Individuals (who)
[1]contract disease and are under treatment.
[2]undergoing hormone replacement procedures.
[3]with skin disease,such as atopic dermatitis.
[4]used a drug to treat a disease in the past 1 month.
[5]have a history of and/or contract serious diseases (eg,liver disease,kidney disease, heart disease,lung disease,blood disease).
[6]whose BMI are 30 or more.
[7]have allergic reaction to ingredients of test foods and other foods or drugs.
[8]have a habit to use Foods with Function Claims, functional foods and/or supplements claiming to improve skin function and/or Anti-glycation in the past 3 months and/or are planning to use those foods during test periods.
[9]drink more than 60g/day on average in terms of pure alcohol.
[10]are smokers.
[11]night worker.
[12]with possible changes of life style during test periods.
[13]will develop seasonal allergy symptoms, such as pollinosis, use an anti-allergic drug.
[14]can't avoid direct sunlight exposure, such as sunburn, during test periods.
[15]had been conducted an operation or beauty treatment on the test spot.
[16]with scars or inflammation at the evaluation site, or feel that skin irritation affecting the examination occurs at the evaluation site before or after menstruation.
[17]are or are possibly pregnant, or are breastfeeding.
[18]are participating and/or had participated in other clinical studies within the last 3 months.
[19]are judged as not appropriate to this study by a responsible doctor.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Yonei |
Organization
Faculty of Life and Medical Sciences,Doshisha University
Division name
Anti-Aging Medical Research Center
Zip code
6100394
Address
1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
TEL
0774-65-6394
yyonei@mail.doshisha.ac.jp
Public contact
Name of contact person
| 1st name | Toshiyasu |
| Middle name | |
| Last name | Tamura |
Organization
TES Holdings Co., Ltd.
Division name
Department of Clinical Trial
Zip code
1100015
Address
6F,Kairaku Bldg,2-7-5 Higashi-Ueno,Taitou-ku,Tokyo
TEL
03-6801-8400
Homepage URL
info@tes-h.co.jp
Sponsor or person
Institute
Anti-Aging Bank Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
AXXZIA Inc.
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
うえのあさがおクリニック(東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | 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
Completed
Date of protocol fixation
| 2025 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2025 | Year | 07 | Month | 04 | Day |
Date analysis concluded
| 2025 | Year | 07 | Month | 22 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 05 | Day |
Last modified on
| 2025 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065388
