UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063078 |
|---|---|
| Receipt number | R000072211 |
| Scientific Title | B-SKIN Trial |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/09/28 15:54:58 |
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Basic information
Public title
Effects of Balenine-Containing Whale Meat Extract Supplementation on Skin Conditioning in Healthy Female University Students
Acronym
B-SKIN Study
Scientific Title
B-SKIN Trial
Scientific Title:Acronym
Balenine Skin Study
Region
| Japan |
Condition
Condition
Healthy adult women
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to investigate the effects of four-week oral supplementation with a balenine-containing whale meat extract on skin condition in healthy female university students. Changes in skin moisture, oil content, elasticity, skin age, skin care index, skin pigmentation, and subjective skin condition before and after the intervention will be compared among the balenine, whale oil, and placebo groups to evaluate the potential beneficial effects of balenine-containing whale meat extract on skin conditioning.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in skin moisture content from baseline (Week 0) to the end of the 4-week intervention (Week 4). Skin moisture content of the right cheek and the dorsum of the right hand will be measured three times using a peipai Skin Checker, and the mean value will be used for analysis.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Participants will orally consume soft capsules containing balenine-containing whale meat extract (100 mg of whale extract B8 plus 150 mg of safflower oil) three times daily after meals for four weeks.
Interventions/Control_2
Participants will orally consume soft capsules containing 300 mg of refined whale oil three times daily after meals for four weeks.
Interventions/Control_3
Participants will orally consume placebo soft capsules containing 300 mg of safflower oil, matched in appearance, weight, and color to the active study products, three times daily after meals for four weeks.
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
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Healthy female university students aged 18-25 years.
2. Individuals who provide written informed consent voluntarily.
3. Individuals who agree not to substantially change their usual dietary and skin-care habits during the study period.
4. Individuals who are able to attend all scheduled measurement sessions.
Key exclusion criteria
1. Individuals with an allergy to whale meat or seafood.
2. Individuals with skin diseases such as atopic dermatitis or psoriasis.
3. Individuals currently receiving treatment for scalp disease or alopecia.
4. Pregnant or breastfeeding women.
5. Individuals judged by a physician to be unsuitable for participation in the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Yamamoto |
Organization
Japanese Red Cross Hokkaido College of Nursing
Division name
Department of Health Sciences
Zip code
0900011
Address
664-1, Akebono-chou, Kitami, Hokkaido
TEL
0157663390
yama@rchokkaido-cn.ac.jp
Public contact
Name of contact person
| 1st name | Noriyuki |
| Middle name | |
| Last name | Yamamoto |
Organization
Japanese Red Cross Hokkaido College of Nursing
Division name
Department of Health Sciences
Zip code
0900011
Address
664-1, Akebono-chou, Kitami, Hokkaido
TEL
0157663390
Homepage URL
yama@rchokkaido-cn.ac.jp
Sponsor or person
Institute
Japanese Red Cross Hokkaido College of Nursing
Institute
Department
Personal name
Funding Source
Organization
Japanese Red Cross Hokkaido College of Nursing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Japanese Red Cross Hokkaido College of Nursing
Address
664-1, Akebono-chou, Kitami, Hokkaido
Tel
0157663311
uemurak@rchokkaido-cn.ac.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 | 10 | Month | 01 | 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
| 2026 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2028 | Year | 03 | 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 | 09 | Month | 28 | Day |
Last modified on
| 2026 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072211
