UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051740 |
|---|---|
| Receipt number | R000059051 |
| Scientific Title | A randomized, placebo-assigned, randomized, double-blind study of improvement in skin condition by ingestion of test food in healthy participant |
| Date of disclosure of the study information | 2025/03/31 |
| Last modified on | 2025/02/25 10:44:00 |
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Basic information
Public title
Skin condition improvement test by ingestion of test food
Acronym
Skin condition improvement test
Scientific Title
A randomized, placebo-assigned, randomized, double-blind study of improvement in skin condition by ingestion of test food in healthy participant
Scientific Title:Acronym
Skin condition improvement study
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the skin condition (skin hydration, elasticity, etc.) is measured before and after intake of the test food (8 weeks), and compared with placebo in a randomized, double-blind study. To evaluate the safety of ingestion the test food by collecting blood and urine.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin hydration (Corneometer)
Skin elasticity (Cutometer)
Transepidermal water evaporation (Tewameter)
Collagen density (Dermalab)
Key secondary outcomes
Physical condition check
Height
Body weight
Blood pressure
Blood/urine collection
Questionnaire
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
6
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake 2.5g / day of placebo food for 8 weeks.
Interventions/Control_2
Intake 2.5g / day of test food A for 8 weeks.
Interventions/Control_3
Intake 2.5g / day of test food B for 8 weeks.
Interventions/Control_4
Intake 2.5g / day of test food C for 8 weeks.
Interventions/Control_5
Intake 2.5g / day of test food D for 8 weeks.
Interventions/Control_6
Intake 2.5g / day of test food E for 8 weeks.
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Healthy women aged 20-70 years.
2) A person who is assumed to be able to receive, agree and complete all explanations.
3) Healthy Japanese with skin concerns.
Key exclusion criteria
1) Pregnant or breastfeeding
2) Those who are prone to anemia
3) Those who are continuously receiving treatment and taking medication for illness
4) Those with a history of cardiovascular disease or renal function
5) Those with nervous system diseases or metabolic disorders
6) Those who are judged to be ineligible by the investigator
7) Those who are taking medication other than the above that may affect the test results
8) Those who have already participated in other clinical trials
9) Those who take collagen peptide every day
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Seiko |
| Middle name | |
| Last name | Koizumi |
Organization
Nitta Gelatin Inc.
Division name
Research & Department Center
Zip code
581-0024
Address
2-22, Futamata, Yao city, Osaka
TEL
072-948-8256
se-koizumi@nitta-gelatin.co.jp
Public contact
Name of contact person
| 1st name | Seiko |
| Middle name | |
| Last name | Koizumi |
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
se-koizumi@nitta-gelatin.co.jp
Sponsor or person
Institute
Nitta Gelatin Inc.
Institute
Department
Personal name
Seiko Koizumi
Funding Source
Organization
Nitta Gelatin Inc.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Kyoso-kai AMC Nishi-Umeda Clinic Ethics Review Committee
Address
3F Maruito Nishiumeda Build. 3-3-45 Umeda, Kita-ku, Osaka
Tel
06-4797-5660
fujimoto@amc-clinic.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
| 2025 | Year | 03 | Month | 31 | 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
Completed
Date of protocol fixation
| 2023 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 01 | 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
| 2023 | Year | 07 | Month | 28 | Day |
Last modified on
| 2025 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059051
