UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056771 |
|---|---|
| Receipt number | R000064393 |
| Scientific Title | Study to verify the effects of test food intake on skin function and intestinal environment |
| Date of disclosure of the study information | 2025/01/21 |
| Last modified on | 2024/12/25 10:35:09 |
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Basic information
Public title
Study to verify the effects of test food intake on skin function and intestinal environment
Acronym
Study to verify the effects of test food intake on skin function and intestinal environment
Scientific Title
Study to verify the effects of test food intake on skin function and intestinal environment
Scientific Title:Acronym
Study to verify the effects of test food intake on skin function and intestinal environment
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 verify the effects of continuous consumption of the test food on skin function and intestinal environment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Indexes for skin function
(Week 0, Week 8)
Key secondary outcomes
*Secondary indexes
1) Observation for skin condition by dermatologists (1)
2) Sensitivity index (1)
3) Intestinal Environment-Related Indices
Intestinal Microflora Analysis (1)
Diary of bowel movements (2)
*Safety
1) Blood pressure, pulsation (1)
2) Weight, body fat percentage, BMI (1)
3) Hematologic test (1)
4) Blood biochemical test (1)
5) Urine analysis (1)
6) Doctor's questions (1)
7) Side effects/ Adverse events (3)
8) Subject's diary (2)
(1):Week 0, Week 8
(2):Everyday From the seven days before the first day of ingestion of a test material to the last day of the test.
(3):Week 8
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 (1 capsule in a day; 8 weeks).
Interventions/Control_2
Oral intake of the placebo food (1 capsule 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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
Individuals
1)Women between 30 and 59 years of age at the time of obtaining consent to participate in the study.
2)who are healthy and have no chronic physical disease including skin disease.
3)who are aware of dry and sagging skin.
4)with spontaneous defecation frequency of 3-4 times per week.
5)who have been fully informed of the purpose and content of the study, have the capacity to consent, understand the study well, voluntarily volunteer to participate, and are able to consent to participation in the study in writing.
6)who can come to the designated venue for this study and be inspected.
7)judged appropriate for the study by the principal.
Key exclusion criteria
Individuals
1)using medical products.
2)who have been diagnosed and are being treated for functional constipation at a medical institution
3)who are determined to have chronic constipation in the diagnostic criteria for chronic constipation.
4)undergoing hormone replacement procedures.
5)with strange skin conditions at measurement points.
6)who used a drug to treat a disease in the past 1 month.
7)who have a history or current history of serious disorders of the liver, kidney, heart, lungs, blood, etc.
8)who are a patient or have a history of or endocrine disease.
9)with mental disabilities.
10)whose BMI is over 30 kg/m2.
11)who may develop allergic symptoms to any of the ingredients in the test food, or who may develop allergic symptoms to any other food or drug.
12)who have a habit of continuous use of foods, foods for specified health uses, foods with functional claims, or health foods that claim to improve skin and bowel movements at present or within the past 3 months that may affect the results of the study.
13)with a current or history of continuous use of food products that may affect the test results within the past 3 months.
14)who excessively take alcohol.
15)who are a smoker.
16)who engage in a night work.
17)with irregular lifestyle or eating habits, and who may change their lifestyle during the examination period.
18)who may develop hay fever or other seasonal allergic symptoms during the study period and may use pharmaceutical medication or nasal drops.
19)who cannot intentionally refrain from being exposed to direct sunlight during the examination period, such as sunburns.
20)who neglect skin care.
21)with wounds or inflammation at the site of evaluation
22)with a history of cosmetic procedures or treatments in the evaluation area.
23)who are or are possibly pregnant, or are lactating.
24)who participated in other clinical studies in the past 3 months.
25)judged inappropriate for the study by the principal.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shigeo |
| Middle name | |
| Last name | Suzuki |
Organization
NIHON BERUMU CO.,LTD
Division name
Research and Development Division
Zip code
103-0001
Address
7F T-PLUS, 16-12 Nihonbashi-Kodenmacho, Chuo-ku, Tokyo 103-0001, JAPAN
TEL
03-6661-0866
info@brm.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
NIHON BERUMU 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
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 | 01 | Month | 21 | 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
| 2024 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 02 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 05 | 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 | 01 | Month | 21 | Day |
Last modified on
| 2024 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064393
