UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035043 |
|---|---|
| Receipt number | R000039953 |
| Scientific Title | Study for the effect of intake of test drink on skin SWE-2018-05-HD1101 |
| Date of disclosure of the study information | 2018/12/02 |
| Last modified on | 2019/12/24 18:45:38 |
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Basic information
Public title
Study for the effect of intake of test drink on skin
SWE-2018-05-HD1101
Acronym
Study for the effect of intake of test drink on skin
Scientific Title
Study for the effect of intake of test drink on skin
SWE-2018-05-HD1101
Scientific Title:Acronym
Study for the effect of intake of test drink on skin
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of drink intake on skin
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of skin condition (screening, Week 0, Week 4, Week 8, Week 12)
Key secondary outcomes
questionnaire (screening, Week 0, Week 4, Week 8, Week 12)
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Drink containing food ingredients, 12 Weeks
Interventions/Control_2
Drink not containing food ingredients, 12 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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
(1)Women aged 40 to 64 years at the time of acquisition of agreement in participating in this study.
(2)Those who can visit the specified institution on the scheduled day of visit
(3)Those who adequately understand the objective and details of this study, and give written informed consent
Key exclusion criteria
(1)Subjects who are or are possibly pregnant, or are lactating.
(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 treatment
(4)Subjects who are with skin disease, such as atopic dermatitis.
(5)Subjects who are with strange skin conditions at measurement points.
(6)Subjects who cannot avoid daylight exposure (such as sunbathing, tanning machine) during the test period.
(7)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.
(8)Subjects who had been conducted an operation on the test spot in the past 1 year.
(9)Subjects who have a habit to use drug claiming to improve skin condition in the past 3 months.
(10)Subjects judged inappropriate for the study by the principal.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao Tanaka |
Organization
SUNTORY WELLNESS LIMITED
Division name
Institute for Health Care Science
Zip code
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL
050-3182-0590
Takao_Tanaka@suntory.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Wakana Taguchi |
Organization
SUNTORY WELLNESS LIMITED
Division name
Institute for Health Care Science
Zip code
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL
050-3182-6122
Homepage URL
Wakana_Taguchi@suntory.co.jp
Sponsor or person
Institute
SUNTORY WELLNESS LIMITED
Institute
Department
Personal name
Funding Source
Organization
SUNTORY WELLNESS LIMITED
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 12 | Month | 02 | 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
| 2018 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 28 | Day |
Last modified on
| 2019 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039953
