UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058242 |
|---|---|
| Receipt number | R000066582 |
| Scientific Title | Evaluation of the effect of plant-derived extract on the maintenance of skin elasticity: a randomized, double-blind, placebo-controlled, parallel-group study |
| Date of disclosure of the study information | 2025/06/24 |
| Last modified on | 2025/06/20 17:16:14 |
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Basic information
Public title
Evaluation of the effect of plant-derived extract on the maintenance of skin elasticity
Acronym
Evaluation of the effect of plant-derived extract on the maintenance of skin elasticity
Scientific Title
Evaluation of the effect of plant-derived extract on the maintenance of skin elasticity: a randomized, double-blind, placebo-controlled, parallel-group study
Scientific Title:Acronym
Evaluation of the effect of plant-derived extract on the 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 plant-derived extract on the maintenance of skin elasticity in healthy Japanese men and women aged 20 years or older who are concerned about skin elasticity, and to additionally evaluate its effects on blood flow and blood levels of nitric oxide metabolites (NOx) as secondary outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The measured value of cheek R7 at 8 weeks after the start of intervention
Key secondary outcomes
a. The measured value of arm R7 at 8 weeks after the start of intervention
b. Measured values at 8 weeks after the start of intervention for the following parameters:
- Cheek skin elasticity (R0, R1, R2, R3, R4, R5, R6, R8, R9)
- Arm skin elasticity (R0, R1, R2, R3, R4, R5, R6, R8, R9)
- Blood flow in the cheek
- Blood flow in the arm
- Blood levels of nitric oxide metabolites (NOx)
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 plant-derived extract capsules for 8 weeks
Interventions/Control_2
Ingestion of placebo 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
i. Japanese participants
ii. Male and female
iii. Aged 20 years or older
iv. In good health
v. Individuals who are concerned about their skin elasticity
Key exclusion criteria
1.Individuals under treatment for or with a history of malignant tumors, heart failure, or myocardial infarction.
2.Individuals with implanted devices such as pacemakers or defibrillators.
3.Individuals under treatment for chronic diseases: arrhythmia, hepatic disorders, chronic kidney disease, cerebrovascular disorders, rheumatic diseases, diabetes, dyslipidemia, hypertension, or other diseases.
4.Individuals under treatment or requiring treatment for other diseases.
5.Individuals with severe anemia.
6.Individuals with drug or food allergies.
7.Individuals with a history of alcohol or drug dependence.
8.Individuals using pharmaceuticals, quasi-drugs, or health foods that claim efficacy for skin health.
9.Individuals with chronic skin conditions such as atopic dermatitis.
10.Individuals with conditions affecting the skin at the evaluation sites.
11.Individuals regularly use skin care products other than basic cosmetics and sunscreen.
12.Individuals regularly receive skin treatments or use beauty devices.
13.Individuals who received cosmetic surgery or special skin treatments last 4 weeks or plan to during the study period.
14.Individuals who changed or started using basic cosmetics or sunscreen last 4 weeks.
15.Individuals who are exposed to excessive ultraviolet rays beyond daily life last 4 weeks or plan to during the study period.
16.Individuals taking hay fever medication.
17.Individuals consuming excessive alcohol.
18.Individuals who smoke or quit within 1 year prior to informed consent.
19.Individuals who plan to travel abroad or go on extended domestic business trips or vacations lasting one week or more during the study period.
20.Women who are pregnant, breastfeeding, or planning to become pregnant during the study period.
21.Individuals working night or rotating shifts.
22.Individuals who participated in another clinical trial last 4 weeks or plan to during the study period.
23.Individuals deemed unsuitable by the principal investigator.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Shigenori |
| Middle name | |
| Last name | Suzuki |
Organization
KAGOME CO., LTD.
Division name
Diet and 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 | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO, Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL
03-3818-0610
Homepage URL
nao@orthomedico.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
医療法人社団盛心会 タカラクリニック（東京都）
Medical Corporation Seishinkai, Takara Clinic（Tokyo, Japan）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 24 | 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 | 06 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 11 | 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 | 06 | Month | 20 | Day |
Last modified on
| 2025 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066582
