UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045525 |
|---|---|
| Receipt number | R000051978 |
| Scientific Title | Effect of the test foods intake test_2021 |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2021/09/21 14:10:38 |
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Basic information
Public title
Effect of the test foods intake test_2021
Acronym
Effect of the test foods intake test_2021
Scientific Title
Effect of the test foods intake test_2021
Scientific Title:Acronym
Effect of the test foods intake test_2021
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of test foods
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood components, skin color, and awareness of sensitive skin and skin condition before and after ingestion of test foods for 8 weeks
Key secondary outcomes
Skin measurements, image data, biological components (stratum layer, flora, SSL-RNA) before and after ingestion of test foods for 4 and 8 weeks
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Consume test foods A twice a day for 8 consecutive days
Interventions/Control_2
Consume test foods B twice a day for 8 consecutive days
Interventions/Control_3
Consume placebo twice a day for 8 consecutive days
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
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
-Healthy females
-Sensitive skin conscious person
Key exclusion criteria
-Subjects have abnormalities on the skin of the test site (face, inside forearm)
-Subjects who attend medical institutions at all times
-Subjects who use the drug at all times
-Subjects with severe atopic dermatitis or hay fever
-Subjects have received cosmetic medicine
-Subjects judged by the person in charge of the examination to be inappropriate
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Tojo |
Organization
Kao Corporation
Division name
Skin Care Products Research Laboratory
Zip code
1318501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, Japan 1318501
TEL
+81-3-5630-9557
tojo.kaori@kao.com
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Haketa |
Organization
Kao Corporation
Division name
Skin Care Products Research Laboratory
Zip code
1318501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, Japan 1318501
TEL
+81-3-5630-7286
Homepage URL
haketa.noriko@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao 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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-7263
morisaki.naoko@kao.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
株式会社インフォワード（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 01 | 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
| 2021 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 21 | Day |
Last modified on
| 2021 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051978
