UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059989 |
|---|---|
| Receipt number | R000068246 |
| Scientific Title | Verification of the Effect of Plant Oil Pressing Cake Extract Intake on Improving Skin Barrier Function |
| Date of disclosure of the study information | 2025/12/07 |
| Last modified on | 2025/11/06 11:38:42 |
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Basic information
Public title
Verification of the Effect of Plant Oil Pressing Cake Extract Intake on Improving Skin Barrier Function
Acronym
Verification of the Effect of Plant Oil Pressing Cake Extract Intake on Improving Skin Barrier Function
Scientific Title
Verification of the Effect of Plant Oil Pressing Cake Extract Intake on Improving Skin Barrier Function
Scientific Title:Acronym
Verification of the Effect of Plant Oil Pressing Cake Extract Intake on Improving Skin Barrier Function
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effects of consuming the test food on skin function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Trans-epidermal water loss
Key secondary outcomes
*Secondary Evaluation Items
1) Skin moisture content
2) Skin viscoelasticity
3) Visual assessment by specialist physician
4) Perceived VAS questionnaire
*Safety Evaluation Items
1) Weight/Body Fat Percentage/BMI
2) Blood Pressure/Pulse Rate
3) Hematological Tests
4) Blood Biochemical Tests
5) Urinalysis
6) Physician Interview/Occurrence of Adverse Reactions/Adverse Event Assessment
7) Subject Diary
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
Oral ingestion of a test food (2 tablets in a day; 8 weeks).
Interventions/Control_2
Oral ingestion of a placebo food (2 tablets in a day; 8 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Males and females aged 20 years or older but under 65 years at the time of obtaining consent to participate in the trial.
2) Healthy individuals without chronic physical diseases, including skin diseases.
3) Individuals concerned about dry skin or rough skin
4) Individuals who have received sufficient explanation regarding the purpose and content of this trial, possess the capacity to consent, voluntarily volunteer to participate after fully understanding, and can provide written consent to participate in this trial.
5) Individuals who can attend the designated examination date and undergo the examination.
6) Individuals deemed suitable for participation in this trial by the principal investigator.
Key exclusion criteria
Individuals
1)currently suffering from any disease and undergoing drug therapy.
2)undergoing hormone replacement therapy.
3)with skin disease symptoms such as atopic dermatitis.
4)with a history of ingesting or applying drugs for disease treatment within the past month.
5)with a history of serious past or current medical conditions involving the liver, kidneys, heart, lungs, blood, digestive tract, or mental disorders.
6)with a BMI of 30.0 kg/m2 or higher.
7)who may experience allergic reactions to components in the test food, or who may experience severe allergic reactions to other foods or pharmaceuticals.
8)who currently have, or have had within the past three months, a habit of continuously using specific health foods, foods with functional claims, or health supplements that promote skin improvement effects.
9)whose average weekly alcohol consumption exceeds 40 g/day for men or 20 g/day for women, converted to pure alcohol.
10)Night shift worker.
11)with a smoking habit.
12)who may have night shifts or changes in lifestyle habits during the trial period.
13)who may have allergy-related itching at the assessment site or may use antiallergic drugs or nasal sprays during the study.
14)unable to refrain from intentional exposure to direct sunlight, such as sunbathing, during the trial period.
15)who neglect skin care to an extreme degree.
16)with a history of cosmetic procedures or treatments on the evaluation site.
17)with wounds or inflammation on the evaluation site, or individuals who feel skin irritation affecting the examination occurs on the evaluation site around the time of menstruation.
18)who are pregnant, breastfeeding, or may become pregnant during the trial period.
19)currently participating in another human clinical trial, or individuals who have not completed participation in another human clinical trial within the past 3 months.
20)Other individuals deemed ineligible for this trial by the principal investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kyoko |
| Middle name | |
| Last name | Shimazu |
Organization
NIPPN CORPORATION
Division name
Central Laboratory
Zip code
243-0041
Address
5-1-3 Midorigaoka, Atsugi-shi, Kanagawa
TEL
046-222-6963
k-shimazu@nippn.co.jp
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
NIPPN CORPORATION
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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 07 | 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 | 10 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 25 | 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 | 12 | Month | 05 | Day |
Last modified on
| 2025 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068246
