UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056289 |
|---|---|
| Receipt number | R000064317 |
| Scientific Title | An examination study of consumption of the test food on transepidermal water loss: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2024/11/28 |
| Last modified on | 2025/01/20 09:58:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
An examination study of consumption of the test food on transepidermal water loss
Acronym
An examination study of consumption of the test food on transepidermal water loss
Scientific Title
An examination study of consumption of the test food on transepidermal water loss: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
An examination study of consumption of the test food on transepidermal water loss
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of consumption of the test food on transepidermal water loss
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The measured values of transepidermal water loss (TEWL) at 12 weeks after the first consumption (12w) (The test food A vs. placebo, the test food B vs. placebo, and the test food C vs. placebo)
Key secondary outcomes
1. The measured values of defecation frequency, number of days with defecation, and amount of defecation in period 2~13*
2. Individuals whose stool shape, stool smell, and exhilarating feeling of defecation improved by >=1 scales in period 2~13* compared to period 1
* Period 1: 7 days prior to screening (before intervention; Scr)
Period 2: For 7 days since the first consumption
Period 3: 8~14 days after consumption
Period 4: 15~21 days after consumption
Period 5: 22~28 days after consumption
Period 6: 29~35 days after consumption
Period 7: 36~42 days after consumption
Period 8: 43~49 days after consumption
Period 9: 50~56 days after consumption
Period 10: 57~63 days after consumption
Period 11: 64~70 days after consumption
Period 12: 71~77 days after consumption
Period 13: From 78 days after consumption to the day before 12w
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
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Test food A
12 weeks
Interventions/Control_2
Test food B
12 weeks
Interventions/Control_3
Test food C
12 weeks
Interventions/Control_4
Placebo
12 weeks
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Japanese
2. Women
3. Adults
4. Healthy individuals
5. Individuals who defecate three to five times in seven days prior to Scr
6. Individuals whose TEWL is high at Scr among those who meet 5
Key exclusion criteria
Individuals who
1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
2. have a pacemaker or an implantable cardioverter defibrillator
3. are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. are taking "Foods for Specified Health Uses (FOSHU)" or "Foods with Functional Claims (FFC)"
5. are taking or using medications and supplements
6. are allergic to medicines or foods related to the test product
7. are engaged in occupations involving outdoor work
8. plan to take trips that will expose them to a lot of sunlight, such as swimming in the sea during this study
9. have been diagnosed with atopic dermatitis
10. use any products except for cosmetic creams, beauty essence, all-in-one cosmetic makeup, skin lotions such as face masks, milky lotions, and sunscreen for daily skincare
11. habitually receive skincare treatment or use instruments for beauty treatment
12. have undergone cosmetic surgery
13. usually take foods containing rich in lactic acid bacteria (LAB), LAB-enriched health foods, or medicines
14. usually take medicines, health foods, FOSHU, or FFC, that may affect bowel movement / take foods fortified with ingredients affecting bowel movement
15. must continue using drug that may affect nasal and eye allergic symptoms during the study, or plan to do so
16. have been diagnosed with premenstrual syndrome or have skin problems before menstruation
17. are pregnant, lactating, or planning to become pregnant during this study
18. have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study
19. are judged as ineligible to participate in this study by the physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Izumi |
Organization
Hiroo Dermatology Clinic & Mentors inc.
Division name
Director
Zip code
150-0012
Address
1&2F Hiroo Masugi Annex Bldg., 5-25-5, Hiroo, Shibuya-ku, Tokyo, Japan
TEL
03-5795-1112
dr_izumi@orthomedico.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
Combi Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hiroo Dermatology Clinic & Mentors inc.
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-clinic.com
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
広尾皮フ科クリニック (東京都)
Hiroo Dermatology Clinic & Mentors inc. (Tokyo, Japan)
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 28 | 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
48
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 29 | 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 | 11 | Month | 28 | Day |
Last modified on
| 2025 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064317
