UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059929 |
|---|---|
| Receipt number | R000068516 |
| Scientific Title | Study of the effects of food ingredients on skin |
| Date of disclosure of the study information | 2025/12/14 |
| Last modified on | 2025/12/01 09:02:35 |
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Basic information
Public title
Study of the effects of food ingredients on skin
Acronym
Study of the effects of food ingredients on skin
Scientific Title
Study of the effects of food ingredients on skin
Scientific Title:Acronym
Study of the effects of food ingredients on skin
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of food ingredients on skin
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Trans Epidermal Water Loss(TEWL)
Key secondary outcomes
skin condition, subjective symptoms
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
Intake of the test foods for 12 weeks.
Interventions/Control_2
Intake of the control foods for 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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy men and women who are between 20 and 59 years old from the time of consent to participate in the study until the end of the study.
(2) Subjects who are able to attend the designated facility on the scheduled visit date.
(3) Subjects who are aware of dry skin.
(4) Subjects who have fully understood the purpose and content of this study and have given their consent.
Key exclusion criteria
(1) Subjects with a systolic blood pressure of less than 90 mmHg
(2) Subjects wishing pregnancy, pregnant or lactating during the study.
(3) Subjects participating in other study or participated within the past 4weeks, or are planning to participate in another clinical trial during the study.
(4) Subjects who fall under any of the following categories:
a) disease on heart, liver, kidney or other organs complications
b) having a history of cardiovascular disease
c) diabetes
d) allergic to the test foods or prescribed diet
e) having a history of serious diseases such as cancer or tuberculosis
f) symptoms of inflammatory skin diseases
(5) Smokers or those who have quit smoking for less than 6months.
(6) Subjects who heavy use of alcohol.
(7) Subjects with extremely irregular eating habits.
(8) Subjects whose lifestyles may become irregular during the study.
(9) Subjects whose assessment areas are deemed difficult to measure.
(10) Subjects who have undergone surgery in the assessment areas within the past year.
(11) Subjects who currently or in the past 3months have been taking or applying medications, quasi-drugs, or cosmetics for the purpose of treating a medical condition.
(12) Subjects who may develop seasonal allergies such as hay fever during the study period and may use medications.
(13) Subjects who currently or within the past three months have taken or are planning to take or apply health foods, foods for specified health uses, pharmaceuticals, quasi-drugs, or cosmetics that may affect the evaluation results, or who plan to do so during the study.
(14) Subjects who regularly engage in sunburn-inducing activities.
(15) Subjects who have undergone any medical procedure or treatment within the past 3months that may affect the evaluation area.
(16) Females with irregular menstrual cycles at the consent.
(17) Females with significant skin irritation during menstruation.
(18) Others who are judged inappropriate for participant by the investigator.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Tanaka |
Organization
Suntory beverage & Food limited.
Division name
Development & Designed Department
Zip code
2110067
Address
13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN
TEL
050-1804-0114
Yasuhiro_Tanaka@suntory.co.jp
Public contact
Name of contact person
| 1st name | Kyoko |
| Middle name | |
| Last name | Takata |
Organization
Suntory beverage & Food limited.
Division name
Development & Designed Department
Zip code
2110067
Address
13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN
TEL
050-1734-6653
Homepage URL
Kyoko_Takata@suntory.co.jp
Sponsor or person
Institute
Suntory Beverage & Food Limited
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.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 | 14 | 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 | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 08 | 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 | 01 | Day |
Last modified on
| 2025 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068516
