UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048597 |
|---|---|
| Receipt number | R000055359 |
| Scientific Title | Observational study to investigate the relationship between skin condition, internal health condition and habitual dietary intake |
| Date of disclosure of the study information | 2024/12/31 |
| Last modified on | 2025/09/29 18:16:52 |
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Basic information
Public title
Observational studies to investigate the relationship between skin, body and diet
Acronym
Observational studies on skin and diet
Scientific Title
Observational study to investigate the relationship between skin condition, internal health condition and habitual dietary intake
Scientific Title:Acronym
Observational study of skin
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For healthy women, comprehensively examine the relationship between skin condition (transepidermal water loss, skin color, etc.), oxidative stress condition in the body, autonomic nerve function, and habitual dietary intake.
Basic objectives2
Others
Basic objectives -Others
Investigate the relationship between skin condition (transepidermal water loss, skin color, etc.), oxidative stress condition in the body, autonomic nerve function, and habitual dietary intake.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Transepidermal water loss
Skin color
Intake of green and yellow vegetables
Dermal carotenoid levels
Serum carotenoid concentrations
Key secondary outcomes
Moisture content of the stratum corneum
State of the stratum corneum
AGEs
Full face photo
Body composition
Vital data
Autonomic nerves
Dietary survey
questionnaire
Blood factors
Urinary factors
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 30 | years-old | <= |
Age-upper limit
| 45 | years-old | > |
Gender
Female
Key inclusion criteria
1. healthy women
2. Aged 30 to 44 years
3. Regular menstrual cycle between 25-38 days
4. The blood sampling date does not correspond to the ovulation period, and the skin measurement date does not correspond to the luteal phase
* As much as possible
5. Outdoor activity time less than 20 hours per week
6. Daily rhythm of waking up in the morning and going to bed at night (excluding night shifts and two shifts)
7. Daily sleep time of 5 hours or more continuously
8. Individuals who agree to participate in the study
Key exclusion criteria
1. Individuals with hay fever
2. Individuals with significant abnormalities in the measurement site
3. Individuals with chronic skin symptoms such as atopic dermatitis at the measurement site
4. Individuals who have undergone treatments that affect the measurement site (stain removal laser, chemical peeling, iontophoresis, etc.) within the past 2 months
5. Individuals who go to the hospital and are using medicines (including taking low-dose pills)
6. Individuals who have participated in other studies within the last 2 months
7. Individuals who are currently taking medicines, foods for specified health uses, foods with nutrition claims, foods with functional claims, and so-called health foods (including beauty supplements) on a daily basis.
8. Individuals who routinely consume nutritionally functional foods intended to supplement vitamins and minerals
9. Individuals who have been using whitening cosmetics (tranexamic acid, hydroquinone-containing quasi-drugs, etc.) in the last 3 months
10. Individuals who have used cosmetics (peeling gel, scrubbed face wash, etc.) for exfoliating the measurement site in the past 3 months
11. Individuals who consume excessive alcohol
12. Smoker
13. Individuals whose lifestyle may change from one week before the exam to the day before the exam (night shift, long trip, etc.)
14. Asthma patients
15. Individuals with symptoms of insomnia
16. Pregnant or planned or lactating individuals
17. Infant parenting individuals
18. Individuals with a BMI of less than 18.5 or a BMI of 25 or higher
19. In addition, individuals (non-cooperative subjects, etc.) who are judged to be inappropriate by the person in charge of the examination or the person in charge of the examination.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Ueda |
Organization
Shiseido Co., ltd.
Division name
Frontier Business R&D
Zip code
220-0011
Address
1-2-11 Takashima nishi-ku Yokohama-shi Kanagawa Japan
TEL
045-222-1600
osamu.ueda@shiseido.com
Public contact
Name of contact person
| 1st name | miho |
| Middle name | |
| Last name | miyanaga |
Organization
Shiseido Co., ltd.
Division name
Frontier Business R&D
Zip code
220-0011
Address
1-2-11 Takashima nishi-ku Yokohama-shi Kanagawa Japan
TEL
045-222-1600
Homepage URL
miho.miyanaga@shiseido.com
Sponsor or person
Institute
Shiseido Co., ltd.
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
KAGOME CO., LTD
Name of secondary funder(s)
IRB Contact (For public release)
Organization
SHISEIDO Research Ethics Committee
Address
1-2-11 Takashima nishi-ku Yokohama-shi Kanagawa Japan
Tel
070-3859-1419
norio.hanzawa@shiseido.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
| 2024 | Year | 12 | Month | 31 | 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
| 2022 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Individuals who meet the inclusion criteria will be recruited and selected by snowball sampling.
Selection will start on August 6, 2022 and will end when the target sample size is reached.
Management information
Registered date
| 2022 | Year | 08 | Month | 05 | Day |
Last modified on
| 2025 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055359
