UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055488 |
|---|---|
| Receipt number | R000063334 |
| Scientific Title | Study of the effects of test food intake on skin function and intestinal microflora |
| Date of disclosure of the study information | 2024/09/11 |
| Last modified on | 2025/11/14 16:59:38 |
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Basic information
Public title
Study of the effects of test food intake on skin function and intestinal microflora
Acronym
Study of the effects of test food intake on skin function and intestinal microflora
Scientific Title
Study of the effects of test food intake on skin function and intestinal microflora
Scientific Title:Acronym
Study of the effects of test food intake on skin function and intestinal microflora
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 examine the effects of the consumption of the test food on skin function and intestinal microflora.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin Physical and Chemical Examination
(Week 0, Week 8)
Key secondary outcomes
*Secondary indexes
1) Intestinal Microflora Analysis (Week 0, Week 8)
2) Observation for skin condition by dermatologists (Week 0, Week 8)
3) Visual Analogue Scale (Week 0, Week 8)
*Safety
1) Blood pressure, pulsation (Week 0, Week 8)
2) Weight, body fat percentage, BMI (Week 0, Week 8)
3) Doctor's questions (Week 0, Week 8)
4) Subject's diary (From the first day of ingestion of a test material to the last day of the test)
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 intake of the test food (Dissolve 1 packet per day in about 100mL of water and consume; 8 weeks).
Interventions/Control_2
Oral intake of the placebo food (Dissolve 1 packet per day in about 100mL of water and consume; 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
| 35 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
1) Women between 35 and 65 years of age at the time of obtaining consent to participate in the study.
2) Individuals who are healthy and have no chronic physical disease including skin disease.
3) Individuals concerned about dry or flaky skin.
4) Individuals with spontaneous defecation frequency of 3-4 times per week.
5) Individuals whose written informed consent has been obtained.
6) Individuals who can come to the designated venue for this study and be inspected.
7) Individuals judged appropriate for the study by the principal.
Key exclusion criteria
1) Individuals using medical products.
2) Individuals who have been diagnosed and are under treatment for functional constipation at a medical institution.
3) Individuals who are determined to have chronic constipation in the diagnostic criteria for chronic constipation.
4) Individuals undergoing hormone replacement procedures.
5) Individuals with skin disease symptoms such as atopic dermatitis.
6) Individuals with wounds or inflammation at the site of evaluation.
7) Individuals who used a drug to treat a disease in the past 1 month.
8) Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease.
9) Individuals who are a patient or have a history of or endocrine disease.
10) Individuals with mental disabilities.
11) Individuals whose BMI is over 30 kg/m2.
12) Individuals who are sensitive to test product or other foods, and medical products.
13) Individuals who have been continuously using lactobacillus-enriched foods, foods for specified health uses, foods with functional claims, or health foods that improve skin and bowel movements at present or within the past three months.
14) Individuals who excessively take alcohol.
15) Individuals who are a smoker.
16) Individuals who engage in a night work.
17) Individuals with possible changes of life style during the test period.
18) Individuals who are at risk of developing hay fever or other seasonal allergic symptoms during the study period and may take pharmaceutical medication or use nasal drops.
19) Individuals who will get sunburned during the test period.
20) Individuals who neglect skin care.
21) Individuals with a history of cosmetic treatment or treatment for the evaluation area.
22) Individuals who are or are possibly pregnant, or are lactating.
23) Individuals who participated in other clinical studies in the past 3 months.
24) Individuals judged inappropriate for the study by the principal.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Nakajima |
Organization
Ueno-Asagao Clinic
Division name
Head
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6240-1162
info@ueno-asagao.clinic
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
Fuji Nihon Seito 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
| 2024 | Year | 09 | 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
Completed
Date of protocol fixation
| 2024 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 11 | Day |
Last modified on
| 2025 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063334
