UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057233 |
|---|---|
| Receipt number | R000065417 |
| Scientific Title | Research on the effects of fermentable dietary fiber on the skin and intestinal environment |
| Date of disclosure of the study information | 2025/03/07 |
| Last modified on | 2025/09/05 09:09:52 |
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Basic information
Public title
Research on the effects of fermentable dietary fiber on the skin and intestinal environment
Acronym
Research on the effects of fermentable dietary fiber on the skin and intestinal environment
Scientific Title
Research on the effects of fermentable dietary fiber on the skin and intestinal environment
Scientific Title:Acronym
Research on the effects of fermentable dietary fiber on the skin and intestinal environment
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects on the skin condition and intestinal environment of adult women between 20 and 50 years of age consuming fermentable dietary fiber-containing foods for 6 consecutive weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin test (stratum corneum moisture content, transepidermal water loss, skin viscoelasticity, VISIA image analysis)
Key secondary outcomes
VAS (Visual Analog Scale) questionnaire
Fecal examination (intestinal microflora, fecal short-chain fatty acid concentration)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consume a fermentable fiber-containing food between meals daily for 6 weeks.
Interventions/Control_2
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
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2.Japanese women who are 20 years old or more and under 50 years old
3.Persons who have concerns about their skin
4.Persons who have concerns about their intestinal health
Key exclusion criteria
1.Persons who have chronic illness, receiving medication, have a serious disease history
2.Persons who are allergic to the test food (especially wheat, eggs, milk, soybeans, peaches, almonds, and oranges)
3.Persons who usually take a large amount of the test food
4.Persons who usually take a large amount of dietary fiber
5.Persons who usually take medicine, specified health food, healthy food and supplements that may have the skin condition or other supplements that are expected to have cosmetic effects
6.Persons who usually take medicine, specified health food, healthy food and supplements that may have the intestinal environment or other supplements that are expected to have cosmetic effects or foods that are expected to have prebiotic or probiotic effects
7.Persons who have experience with cosmetic treatments on the face
8.Persons who have inflammation or skin diseases on the face
9.Persons who are undergoing hormone replacement therapy
10.Persons who have eyelash extensions
11.Persons who have artificial makeup on the outer corner of the eyes
12.Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam
13.Persons who were judged as inappropriate for study participants by the principal investigator
14.Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kosei |
| Middle name | |
| Last name | Nishikawa |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Park Place Bld. 5F, 5-27-1, Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
0368092722
nishikawa@hc-sys.jp
Public contact
Name of contact person
| 1st name | Kosei |
| Middle name | |
| Last name | Nishikawa |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Park Place Bld. 5F, 5-27-1, Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
0368092722
Homepage URL
nishikawa@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Fermentable Dietary Fiber Dissemination Project, Inc.
Mizkan 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
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18 Shirakane, Showa-ku, Nagoya city, Aichi, JAPAN
Tel
0368092722
soumu@hc-sys.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 | 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
14
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
| 2025 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | 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 | 03 | Month | 07 | Day |
Last modified on
| 2025 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065417
