UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060288 |
|---|---|
| Receipt number | R000068681 |
| Scientific Title | A Study on the Effects of the Test Food on Skin -A Randomized, Double-blind, Placebo-controlled Parallel-group Study- |
| Date of disclosure of the study information | 2026/01/11 |
| Last modified on | 2026/01/08 17:27:20 |
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Basic information
Public title
A Study on the Effects of the Test Food on Skin -A Randomized, Double-blind, Placebo-controlled Parallel-group Study-
Acronym
A Study on the Effects of the Test Food on Skin
Scientific Title
A Study on the Effects of the Test Food on Skin -A Randomized, Double-blind, Placebo-controlled Parallel-group Study-
Scientific Title:Acronym
A Study on the Effects of the Test Food on Skin
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of continuous 8-week intake of the test food on skin in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Transepidermal water loss at 8 weeks
Key secondary outcomes
1) Stratum corneum water
2) Skin elasticity
3) Stratum corneum analysis
4) Puerefactive products in feces
5) blood phenol
6) blood malondialdehyde
7) concentrations of salivary cortisol
8) Image analysis by VISIA
9) Visual Analogue Scale
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
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of the test food (1 pack a day, 8weeks)
Interventions/Control_2
Consumption of the placebo food (1 pack 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
Female
Key inclusion criteria
1) Premenopausal women aged 20-64 years
2) Subjects with constipation tendencies having mainly 3-5 bowel movements per week at the time of screening
3) Subjects who have a regular diet (three meals a day (breakfast, lunch, and dinner ))
4) Subjects who are concerned about drying of the skin as subjective symptoms
5) Subjects who use only one or two items of skin care products, such as lotion and emulsion, after daily face washing
6) Subjects who have received a sufficient explanation regarding the purpose and details of this study, are capable of providing informed consent, fully understand the information provided, and voluntarily agree in writing to participate in this study
Key exclusion criteria
1) Subjects who meet the diagnostic criteria for chronic constipation in the clinical guidelines for chronic constipation 2023
2) Subjects who regularly consume large amounts of foods containing active ingredient, or health foods containing active ingredient
3) Subjects who regularly take medications, including intestinal regulators, laxatives, and purgatives (regulators are permissible if discontinued from screening to study end)
4) Subjects with severe liver, kidney, digestive, heart, respiratory, endocrine, thyroid, adrenal diseases, or other metabolic disorders (excluding transient conditions such as the common cold)
5) Subjects who have a digestive disease that affects digestion and absorption, or a history of surgery (excluding appendicitis)
6) Subjects who have a history or current medical history of drug dependence or alcoholism
7) Subjects who are diagnosed with chronic constipation
8) Subjects who are unable to stop taking health foods or supplements (including FOSHU/FFC) that may affect this study
9) Subjects who have a habit of drinking excessively (>= 20g pure alcohol eq./day, >= 4 days/week)
10) Subjects who have a habit of smoking excessively (>= 21 cigarettes/day)
11) Shift worker or night-shift worker (excluding daytime shift work)
12) Subjects who plan to travel overseas or domestic long-term for personal or business purposes (> 10 days/month), or be transferred during this study
13) Subjects who have donated > 200 mL blood/component blood within one month or > 400 mL within three months prior to screening test
14) Subjects who consume yogurt, lactic acid bacteria, or bifidobacteria-containing foods >= 3 times/week, or unwillingness to refrain during the study
15) Subjects who have any factors on the skin of the evaluation site that may affect the test results (such as diseases like urticaria, inflammation, eczema, trauma, acne, pimples, warts, spots, or their traces)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Wakako |
| Middle name | |
| Last name | INOUE |
Organization
Yawara Dermatology Clinic
Division name
Director
Zip code
530-0041
Address
4F Sakashin Tenjinbashi Bldg., 5-7-10 Tenjinbashi, Kita-ku, Osaka-shi, Osaka, Japan
TEL
06-6881-1000
drc_shokuhin@drc-web.co.jp
Public contact
Name of contact person
| 1st name | Akifumi |
| Middle name | |
| Last name | NAGATOMO |
Organization
Morishita Jintan Co., Ltd.
Division name
Research and Development Headquarters, Fundamental Research and Development Department
Zip code
573-0128
Address
11-1, Tsudayamate 2-Chome, Hirakata-Shi, Osaka, Japan
TEL
072-800-1044
Homepage URL
a-nagatomo@jintan.co.jp
Sponsor or person
Institute
Morishita Jintan Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Morishita Jintan 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
Brain Care Clinic Ethics Review Committee.
Address
Shiratori Build. 2F, 2-1-2 Shinjuku, Shinjuku-ku, Tokyo
Tel
03-6273-2214
ethics_board@drc-web.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
| 2026 | Year | 01 | Month | 11 | 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 | 30 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Continued Key exclusion criteria)
16) Subjects who have a history or current history of atopic dermatitis, or a predisposition to atopy
17) Subjects who have received cosmetic medical treatments (such as Botox, hyaluronic acid or collagen injections, photofacials, etc.) on the evaluation site, or plan to receive such treatments during the study
18) Subjects who have received or plan to receive specialized skincare treatments (at beauty salons, spas, etc.) on the evaluation site within the past 4 weeks or during the study
19) Subjects using daily skincare products (such as creams, all-in-one gels, serums, or masks), quasi-drugs containing functional ingredients (barrier or skin roughness repair, whitening, etc.), or cosmetics containing potent antioxidants (such as niacinamide or vitamin C) on the evaluation site
20) Subjects who changed or newly started using basic skincare products or sunscreen on the evaluation site within the past 4 weeks
21) Subjects who have been exposed to UV light exceeding normal daily levels (such as prolonged outdoor work, exercise, swimming, or leisure activities) within the past 4 weeks, or who plan to have such exposure during the study
22) Subjects who have undergone or are scheduled to undergo special skin cares (beauty salons, esthetic clinics, etc.) on the evaluation site within the past 4 weeks
23) Subjects at risk of developing allergies to cosmetics and food (including those who have experienced skin abnormalities such as rashes due to cosmetics within the past 1 year)
24) Subjects who are pregnant, lactating, or intending to become pregnant during this study
25) Subjects who have participated in any other human studies (using cosmetics, foods, pharmaceuticals, quasi-drugs, medical devices, etc.) within the past 4 weeks, or scheduled to participate in any other human studies during this study
26) Subjects who are judged by the principal investigator to be ineligible for study participation for other reasons
Management information
Registered date
| 2026 | Year | 01 | Month | 07 | Day |
Last modified on
| 2026 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068681
