UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000057132 |
|---|---|
| Receipt number | R000065305 |
| Scientific Title | A placebo-controlled double-blind study of improvement of skin elasticity and moisture by ingestion of test food in healthy participant |
| Date of disclosure of the study information | 2026/04/30 |
| Last modified on | 2025/02/26 00:36:22 |
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Basic information
Public title
Effect evaluation test on improvement of skin elasticity and moisture by ingestion of test food
Acronym
Effect evaluation test on improvement of skin elasticity and moisture by ingestion of test food
Scientific Title
A placebo-controlled double-blind study of improvement of skin elasticity and moisture by ingestion of test food in healthy participant
Scientific Title:Acronym
Improvement of skin elasticity and moisture test
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect of collagen peptide intake on improving skin elasticity and moisture compared to placebo and before intake by evaluating skin condition before and after intake of the test food (1 week) in a placebo-controlled double-blind study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin elasticity, skin moisture content, skin evaporation rate, collagen content, dermis thickness
Key secondary outcomes
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
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake placebo food for 4 weeks.
Interventions/Control_2
Intake 20g / day of test food A for 4 weeks.
Interventions/Control_3
Intake 10g / day of test food A for 4 weeks.
Interventions/Control_4
Intake 20g / day of test food B for 4 weeks.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Age: 30 years old or older, 60 years old or younger
2) Gender: Male and female
3) Healthy individuals with skin problems
4) Those who can provide written consent to participate in the study
5) Those who expected to be able to complete the study
Key exclusion criteria
1) Pregnant or breastfeeding women
2) Those prone to anemia
3) Those currently undergoing ongoing medical treatment or taking medication
4) Those with a history of cardiovascular disease or renal dysfunction
5) Those with nervous system disease or metabolic disorders
6) Those deemed inappropriate by the principal investigator
7) Those taking medication other than those listed above that may affect the results of the study
8) Those already participating in other clinical trials
9) Those who have taken collagen continuously within the past month prior to starting this study
Target sample size
88
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | Murata |
Organization
Nitta Gelatin Inc.
Division name
Research Department Center
Zip code
581-0024
Address
2-22, Futamata, Yao city, Osaka
TEL
072-948-8256
me-murata@nitta-gelatin.co.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Murata |
Organization
Nitta Gelatin Inc.
Division name
Research Department Center
Zip code
581-0024
Address
2-22, Futamata, Yao city, Osaka
TEL
072-948-8256
Homepage URL
me-murata@nitta-gelatin.co.jp
Sponsor or person
Institute
Nitta Gelatin Inc.
Institute
Department
Personal name
Funding Source
Organization
Nitta Gelatin Inc.
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
Medical Corporation Osaka Nishiumeda Clinic Research Ethics Review Committee
Address
3F Maruito Nishiumeda Build. 3-3-45 Umeda, Kita-ku, Osaka
Tel
06-4797-5660
nouchi@taifukukai.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
| 2026 | Year | 04 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 02 | 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 | 02 | Month | 26 | Day |
Last modified on
| 2025 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065305
