UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058897 |
|---|---|
| Receipt number | R000067341 |
| Scientific Title | A placebo-controlled randomized double-blind parallel-group comparison study on the effects of continued intake of collagen peptides on the skin and scalp |
| Date of disclosure of the study information | 2025/08/27 |
| Last modified on | 2025/08/25 10:19:46 |
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Basic information
Public title
A placebo-controlled randomized double-blind parallel-group comparison study on the effects of continued intake of collagen peptides on the skin and scalp
Acronym
A placebo-controlled randomized double-blind parallel-group comparison study on the effects of continued intake of collagen peptides on the skin and scalp
Scientific Title
A placebo-controlled randomized double-blind parallel-group comparison study on the effects of continued intake of collagen peptides on the skin and scalp
Scientific Title:Acronym
A placebo-controlled randomized double-blind parallel-group comparison study on the effects of continued intake of collagen peptides on the skin and scalp
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effects on skin and scalp by continuously ingestion of test food for 12 weeks
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Moisture content of stratum corneum
Transepidermal water loss
Skin elasticity
Key secondary outcomes
Scalp elasticity(hardness)
Scalp transdermal water evaporation rate
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
Intake of test food for 12 consecutive weeks
Interventions/Control_2
Intake of control placebo food for 12 consecutive 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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy men and women aged 20 to 64
(2) Individuals with dry skin and scalp
(3) Individuals who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing
Key exclusion criteria
(1) Individuals with a history of mental illness, diabetes, liver disease, renal diseases, gastrointestinal disease, cardiac disease, respiratory disease, peripheral vascular disease, or other serious disease.
(2) Individuals who have undergone gastrointestinal surgery.
(3) Individuals showing abnormal liver and kidney function test values.
(4) Individualswith a current medical condition.
(5) Individuals with skin symptoms.
(6) Individuals who are allergic to food and drugs.
(7) Individuals with symptoms of anemia.
(8) Females wishing to become pregnant while participating in this study, pregnant (including those who may be pregnant) or lactating female subjects.
(9) Individuals who participate in strenuous sports and subjects who are trying to lose weight.
(10) Individuals with extremely irregular eating habits.
(11) Individuals who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the study period.
(12) Individuals who are continuously treated with medications (including OTC, prescription drugs).
(13) Individuals who drink more than 40 g of average daily pure alcohol.
(14) Individuals who smoke an average of 21 or more cigarettes a day.
(15) Individuals who are currently participating in other clinical studies or are scheduled to participate in research at the start of this study.
(16) Individuals judged by the principal investigator or the associate investigator to be inappropriate for the examination.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Miura |
Organization
Miura Clinic, Medical Corporation Kanonkai
Division name
Internal medicine
Zip code
5300044
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
TEL
06-6135-5200
info@miura-cl.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Terashima |
Organization
Makoto Terashima
Division name
Clinical Trial Division
Zip code
5300044
Address
Higashitenma building 6F, 1-7-17, Higashitenma, Kita-ku, Osaka
TEL
06-4801-8917
Homepage URL
mterashima@oneness-sup.co.jp
Sponsor or person
Institute
Miura Clinic, Medical Corporation Kanonkai
Institute
Department
Personal name
Funding Source
Organization
Nestle Japan 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
The Ethics Committee of Miura Clinic, Medical Corporation Kanonkai
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
Tel
06-6135-5200
mterashima@miura-cl.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
医療法人花音会みうらクリニック（大阪府）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 27 | 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 | 08 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2025 | 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
| 2025 | Year | 08 | Month | 26 | Day |
Last modified on
| 2025 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067341
