UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042353 |
|---|---|
| Receipt number | R000048350 |
| Scientific Title | Study for the effect of intake of test food on skin SME-2020-02-HRCT(SW08) |
| Date of disclosure of the study information | 2020/11/23 |
| Last modified on | 2021/07/13 09:43:07 |
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Basic information
Public title
Study for the effect of intake of test food on skin
SME-2020-02-HRCT(SW08)
Acronym
Study for the effect of intake of test food on skin
Scientific Title
Study for the effect of intake of test food on skin
SME-2020-02-HRCT(SW08)
Scientific Title:Acronym
Study for the effect of intake of test food on skin
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of food intake on skin
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of skin brightness between before and after the period of food intake
Key secondary outcomes
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
Intake of the test food containing active ingredients for 12 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
| 36 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Women aged 36 to 45 years at the time of acquisition of agreement in participating in this study.
(2) Subjects who can visit the specified institution on the scheduled day of visit
(3) Subjects who adequately understand the objective and details of this study, and give written informed consent
(4) Subjects who are concerned about the skin condition of their face
Key exclusion criteria
(1) Subjects whose are pregnant (including those who may be pregnant) or breastfeeding
(2) Subjects who are; a)With present heart disorder, liver disorder, or kidney disorder, b)With history of cardiac disorder, c)With diabetes mellitus, or d)With allergy to the study foods.
(3) Subjects who are with skin disease, such as atopic dermatitis or with strange skin conditions at measurement points.
(4) Subjects who cannot avoid daylight exposure (such as sunbathing, tanning machine) during the test period.
(5) Subjects who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements claiming to improve skin condition the past 3 months or will ingest those foods during the test period.
(6) Subjects who had been conducted an operation on the test spot in the past 1 year.
(7) Subjects judged inappropriate for the study by the principal.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | OBATA |
Organization
SUNTORY MONOZUKURI EXPERT LIMITED
Division name
HE Center
Zip code
135-8631
Address
2-3-3 Daiba, Minato-ku, Tokyo
TEL
03-5579-1277
Hidenori_Obata@suntory.co.jp
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | IZUMI |
Organization
SUNTORY MONOZUKURI EXPERT LIMITED
Division name
HE Center
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto
TEL
050-3182-0631
Homepage URL
Reiko_Izumi@suntory.co.jp
Sponsor or person
Institute
SUNTORY MONOZUKURI EXPERT LIMITED
Institute
Department
Personal name
Funding Source
Organization
SUNTORY WELLNESS LIMITED
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
Institutional Review Board of Uenoasagao Clinic
Address
2-7-5 Higashiueno, Taito-ku, Tokyo
Tel
03-6240-1162
info@ueno-asagao.clinic
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
| 2020 | Year | 11 | Month | 23 | 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
50
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
| 2020 | Year | 11 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 05 | Day |
Last modified on
| 2021 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048350
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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