UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000057287 |
|---|---|
| Receipt number | R000065424 |
| Scientific Title | Evaluation of skin condition improvement by ingestion of the test food: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2026/06/19 |
| Last modified on | 2025/03/14 13:54:42 |
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Basic information
Public title
Evaluation of skin condition improvement by ingestion of the test product
Acronym
Evaluation of skin condition improvement by ingestion of the test product
Scientific Title
Evaluation of skin condition improvement by ingestion of the test food: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
Evaluation of skin condition improvement by ingestion of the test food
Region
| Japan |
Condition
Condition
N/A(healthy adults)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effect of the test product ingestion on skin condition improvement
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin elasticity
(Week 0, Week 8)
Key secondary outcomes
Skin moisture content
Skin blood flow
Subjective skin evaluation
(Week 0, Week 8)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral intake of test food once daily for 8 weeks
Interventions/Control_2
Oral intake of placebo food once daily 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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Healthy Japanese males and females aged 35 to 59 years old
2) Subjects who feel dry skin
3) Subjects who feel loss in skin elasticity
4) Subjects who feel rough skin
Key exclusion criteria
1) Subjects who spend a lot of time outdoors or exposed to ultraviolet rays in their daily lives (e.g., those who work night shifts or day/night shifts, those who engage in sales or delivery work, etc.)
2) Subjects who take or apply medications (e.g., medicines with moisturizing effects) that may affect test results
3) Subjects who regularly use specified health foods, functional foods (e.g., food containing sodium hyaluronate, glucosylceramide, astaxanthin), or health foods (including supplements) that may affect the improvement of skin quality and who are unable to discontinue from the time consent is obtained
4) Subjects who have undergone facial beauty treatments or beauty clinics within 2 weeks prior to the start of the examination
5) Subjects who are taking or will take medication for hay fever
6) Subjects who can be allergic to the test food
7) Subjects who may show allergic symptoms to any of the ingredients in the test product
8) Subjects with asthma
9) Subjects who are a smoker
10) subjects who cannot intentionally refrain from direct exposure to the sun, such as sunburns and long-term travel between pre-inspection and the end of the examination
11) Subjects who have irregular lifestyle habits, such as waking and sleeping times that vary by 4 hours or more depending on the day of the week
12) Pregnant or possibly pregnant, and lactating mothers
13) Subjects who have skin allergy symptoms or skin hypersensitivity
14) Subjects who have chronic inflammation of the skin such as atopic dermatitis
15) Subjects who have chronic diseases and regularly use drugs
16) Subjects who have remarkable abnormality on skin condition of the test area
17) Subjects who participate in other clinical trials
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Koikeda |
Organization
Shiba Palace Clinic
Division name
Chair
Zip code
105-0013
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
03-5408-1599
jimukyoku@mail.souken-r.com
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Inoue |
Organization
Hayashikane Sangyo Co., Ltd.
Division name
functional food division
Zip code
750-8608
Address
2-4-8 Yamatomachi, Shimonoseki-Shi, Yamaguchi, JAPAN
TEL
083-267-0094
Homepage URL
yinoue@hayashikane.com
Sponsor or person
Institute
Shiba Palace Clinic
Institute
Department
Personal name
Funding Source
Organization
Hayashikane Sangyo 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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
jimukyoku@mail.souken-r.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
芝パレスクリニック
（Shiba Palace Clinic）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 19 | 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 | 01 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 06 | 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
| 2025 | Year | 03 | Month | 14 | Day |
Last modified on
| 2025 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065424
