UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059473 |
|---|---|
| Receipt number | R000068022 |
| Scientific Title | Evaluation of the effect of a test product on the skin maintenance of skin elasticity |
| Date of disclosure of the study information | 2025/10/21 |
| Last modified on | 2025/10/20 16:19:28 |
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Basic information
Public title
Evaluation of the effect of a test product on the skin maintenance of skin elasticity
Acronym
Evaluation of the effect of a test product on the skin maintenance of skin elasticity
Scientific Title
Evaluation of the effect of a test product on the skin maintenance of skin elasticity
Scientific Title:Acronym
Evaluation of the effect of a test product on the skin maintenance of skin elasticity
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of a test product on the skin elasticity in men and women aged 35 to 50.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The value of skin elasticity (F3) at 12 weeks after the start of intake
Key secondary outcomes
The value of following items measured 12 weeks after the start of intake
･Skin elasticity (R0, R1, R2, R3, R4, R5, R6, R7, R8, R9, R10, F0, F1, F2, F4)
･Moisture content of the dermis
･Skin carotenoid level
･Serum beta-carotene concentration
･Serum malondialdehyde
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
Ingestion of active beverage for 12 weeks
Interventions/Control_2
Ingestion of placebo beverage 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
| 35 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Healthy Japanese men and women aged 35 to 50 at the time of obtaining consent to participate in the study
2.Individuals who are concerned about skin elasticity
Key exclusion criteria
1. Individuals currently receiving outpatient treatment and using medications
2. Individuals consuming vegetable or vegetable-fruit mix juice three or more times per week
3. Individuals consuming either carrots, pumpkin, spinach, or chrysanthemum greens a total of at least three or more times per week
4. Individuals currently consuming supplements containing carotenoids three or more times per week
5. Individuals currently consuming medications, quasi-drugs, specific health foods, nutritional supplements, functional foods, or so-called health foods that claim skin elasticity improvement, moisturizing effects, or estrogen-like effects at least three times per week
6. Individuals unable to refrain from activities involving excessive UV exposure beyond daily life during the study period.
7. Individuals who have undergone cosmetic procedures on the measurement site
8. Individuals who have received body esthetic treatments on the measurement site within the past month
9. Individuals with chronic skin conditions such as atopic dermatitis
10. Individuals with abnormalities on the measurement site, such as wounds or inflammation
11. Smokers
12. Individuals with a physical constitution that may interfere with blood collection
13. Individuals at risk of showing allergic symptoms upon food
14. Individuals whose average weekly alcohol consumption, converted to pure alcohol, exceeds 40 g/day for men and 20 g/day for women
15. Individuals with asthma
16. Individuals with hay fever
17. Individuals with a BMI below 18.5 or above 25.0
18. Individuals planning overseas travel or extended domestic travel during the study period
19. Individuals working night shifts or rotating shifts
20. Women who are pregnant, breastfeeding, or planning to become pregnant during the study period
21. Individuals participating in another clinical study within the past three months
22. Any other individuals deemed ineligible for this study by the principal investigator
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Shigenori |
| Middle name | |
| Last name | Suzuki |
Organization
KAGOME CO., LTD.
Division name
Diet & Well-being Research Institute
Zip code
329-2762
Address
17 Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
0287-36-2935
G167_0@kagome.co.jp
Public contact
Name of contact person
| 1st name | Kanako |
| Middle name | |
| Last name | Sakurai |
Organization
Inforward, inc
Division name
Ebisu skin research center
Zip code
150-0013
Address
5F Sankei Building, 1-11-2 Ebisu, Shibuya-ku, Tokyo
TEL
03-5793-8712
Homepage URL
sakurai@inforward.co.jp
Sponsor or person
Institute
KAGOME CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
KAGOME 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
KAGOME CO.,LTD. Research Ethics Review Committee
Address
Nihonbashi Hamacho F Tower, 3-21-1 Nihonbashi Hamacho, Chuo-ku, Tokyo
Tel
03-5623-8501
IRB@kagome.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 | 10 | Month | 21 | 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 | 10 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 10 | 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 | 10 | Month | 20 | Day |
Last modified on
| 2025 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068022
