UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060289 |
|---|---|
| Receipt number | R000068935 |
| Scientific Title | Effects of salmon nasal cartilage proteoglycan intake on the skin |
| Date of disclosure of the study information | 2026/01/08 |
| Last modified on | 2026/01/07 17:55:14 |
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Basic information
Public title
Verification of the effects of ingesting salmon nasal cartilage components on the skin
Acronym
Effects of salmon cartilage intake on the skin
Scientific Title
Effects of salmon nasal cartilage proteoglycan intake on the skin
Scientific Title:Acronym
Effects of proteoglycan intake on the skin
Region
| Japan |
Condition
Condition
Adult men and women
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effectiveness of proteoglycan intake in preventing and improving skin fragility
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in dermal collagen density over 20 weeks
Key secondary outcomes
Changes in stratum corneum moisture content over 20 weeks, Changes in dermal collagen thickness, Changes in the Mini-Nutrition Assessment (MNA-Short Form), Change in skin elasticity, Change in width of the area where elastin is denatured just below the epidermis
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Participants will take one packet of proteoglycan-containing food (10 mg, Ichimaru Pharcos Co., Ltd.) between meals (between breakfast and lunch, lunch and dinner, or dinner and before bedtime) for 12 weeks. Primary and secondary endpoints will be measured at baseline, 4 weeks, 8 weeks, 12 weeks, and 20 weeks.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Adult males and females
(2) Subjects who can be evaluated at the start of the study and at weeks 4, 8, 12, and 20
Key exclusion criteria
(1) Subjects with skin disorders currently using topical medications (including moisturizers) on the measurement area.
(2) Subjects currently using steroids.
(3) Subjects with severe liver or renal dysfunction.
(4) Subjects with heart failure (NYHA classification II or higher) that limits physical activity.
(5) Subjects with severe infections, serious injuries, or arthritis.
(6) Subjects with a salmon allergy.
(7) Subjects currently or within the past three months have been taking functional foods, health foods, or supplements that claim to improve skin health.
(8) Subjects with a history of cosmetic procedures or treatments on the measurement area within the past six months.
(9) Subjects deemed inappropriate for this clinical study by the attending physician or principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Noboru |
| Middle name | |
| Last name | Makabe |
Organization
Kansai Electric Power Hospital
Division name
Center for Metabolism and Clinical Nutrition
Zip code
553-0003
Address
2-1-7 Fukushima, Fukushima Ward, Osaka City, Osaka
TEL
06-6458-5821
nmakabe@cocoa.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Moyama |
Organization
Kansai Electric Power Hospital
Division name
Center for Metabolism and Clinical Nutrition
Zip code
553-0003
Address
2-1-7 Fukushima, Fukushima Ward, Osaka City, Osaka
TEL
06-6458-5821
Homepage URL
shota0531@gmail.com
Sponsor or person
Institute
Kansai Electric Power Medical Research Institute
Institute
Department
Personal name
Funding Source
Organization
Ichimaru Pharcos 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
Kansai Electric Power Hospital
Address
2-1-7 Fukushima, Fukushima Ward, Osaka City, Osaka
Tel
06-6458-5821
nishioka.yasunori@e4.kepco.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
関西電力病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 08 | 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 | 12 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 07 | Day |
Last modified on
| 2026 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068935
